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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 07/11/2023, has been considered by the examiner.
Claim Rejections - 35 USC § 112
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 31 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 31, which depends directly from independent claim 21, repeats the limitation of “wherein the outer structural layer is capable of independently operating as a balloon having a rated burst pressure of at least about 30 atm” (as recited in claim 21), without any additional limitations. As such, the claim is not further limiting. 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.
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 21-23, 26, 28, 30-32, 35, 36, and 38-40, are rejected under 35 U.S.C. 103 as being unpatentable over Beyar et al. (PGPub 2006/0190022), in view of Devens, Jr. et al. (USPN 9,180,620).
[Claims 21, 31, and 32] Beyar teaches a medical balloon (figure 5e, item 540) comprising:
an inner structural layer (figure 5e, item 526) comprising a polymeric material (Beyer describes item 526 as an “inner balloon”; the examiner notes all balloons are polymeric, also see [0229]), wherein the inner structural layer (figure 5e, item 526) is free from reinforcing fibers (figure 5e; the layer 526 is free from reinforcing fibers) (figure 5e; paragraph [0270]);
an outer structural layer (figure 5e, item 502) disposed radially outward of the inner structural layer (figure 5e, item 526) (figure 5e; paragraph [0270]),
wherein the outer structural layer (figure 5e, item 502) is capable of independently operating as a balloon having a rated burst pressure of at least about 40 atm (Beyar teaches the outer balloon 502 does not rupture at pressures below at least 100 atmospheres) (paragraph [0271]).
Beyar does not specifically disclose the outer structural layer comprises reinforcing fibers suspended in a polymeric matrix.
However, Devens, Jr. teaches a medical balloon (figure 1, item 22) comprising an inner structural layer (figure 2, item 26) and an outer structural layer (figure 2, item 28); wherein the outer structural layer (figure 2, item 28) comprises reinforcing fibers (“LCP fibers”) suspended in a polymeric matrix (“LCP fibers can reinforce the other polymer(s) contained in the layer (e.g., matrix polymer(s))”) (column 6, lines 63-67; column 7, lines 58-67; column 8, lines 1-20).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Beyar, with the use of reinforcing fibers in the outer structural layer, as taught by Devens, Jr., in order to provide increased functionality and control, by allowing for a means by which the geometry of the outer balloon might be maintained during inflation, thereby providing precision during the application of treatment (Devens, Jr.; column 8, lines 14-20). Further, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
[Claim 22] Beyar and Devens, Jr. teach the limitations of claim 21, upon which claim 22 depends. In addition, Beyar discloses the inner structural layer (figure 5e, item 526) is capable of independently operating as a balloon having a rated burst pressure of less than 30 atm (Beyar teaches the inner balloon 526 can have a burst pressure of less than 30 atmospheres) (paragraph [0271]).
[Claims 23, 26, and 30] Beyar and Devens, Jr. teach the limitations of claims 21 and 22, upon which claims 23, 26, and 30, depend. Beyar further discloses the inner structural layer (figure 5e, item 526) has a compliance and elasticity that is greater than the outer structural layer (figure 5e, item 502) (the examiner notes that the inner layer 526 has a lower burst pressure than the outer layer 502; thus, the inner layer has a compliance and elasticity greater than the outer layer) (paragraphs [0271], [0272]).
[Claim 28] Beyar and Devens, Jr. teach the limitations of claim 21, upon which claim 28 depends. Beyar does not specifically disclose the inner structural layer has a shore hardness that is less than a shore hardness of the outer structural layer.
However, Devens, Jr. teaches the layers may be of progressively increasing hardness from the innermost layer to the outermost layer (column 7, lines 13-18).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Beyar and Devens, Jr., such that the inner structural layer has a shore hardness that is less than a shore hardness of the outer structural layer, as taught by Devens, Jr., in order to provide increased control and safety, by allowing for a means by which the outer layer of the balloon might be less susceptible to damage and/or rupture during delivery of therapy.
[Claims 35, 36, and 38-40] Beyar and Devens, Jr. teach the limitations of claim 21, upon which claims 35, 36, and 38-40, depend. In addition, Beyar teaches a structure and method of forming wherein:
each of the inner structural layer (figure 5e, item 526) and the outer structural layer (figure 5e, item 502) includes a balloon body section (see annotated figure below), opposite distal and proximal waist sections (see annotated figure below), and
opposite distal and proximal cone sections (see annotated figure below) between the balloon body and the respective distal and proximal waist sections (see annotated figure below),
wherein the inner structural layer (figure 5e, item 526) and the outer structural layer (figure 5e, item 502) are secured to one another at the corresponding distal and proximal waist sections (see annotated figure below),
wherein the inner structural layer (figure 5e, item 526) and the outer structural layer (figure 5e, item 502) are unsecured to one another along the balloon between the distal and proximal waist sections (figure 5e);
wherein the inner structural layer (figure 5e, item 526) and the outer structural layer (figure 5e, item 502) are configured to slide relative to one another at the respective body sections (figure 5e) (the examiner notes the claim does not define how the two layers are required to “slide” relative to one another).
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Claims 24, 25, 27 are rejected under 35 U.S.C. 103 as being unpatentable over Beyar et al. (PGPub 2006/0190022), in view of Devens, Jr. et al. (USPN 9,180,620), in further view of Pendleton et al. (PGPub 2016/0228662).
[Claims 24 and 27] Beyar and Devens, Jr. teach the limitations of claims 23 and 26, upon which claims 24 and 27 depend. Beyar and Devens, Jr. do not specifically disclose the compliance of the inner structural layer is from about 4% to about 7%.
However, Pendleton teaches a medical balloon (figure 11, item 42) having an inner structural layer (figure 11, item 46) and an outer structural layer (figure 11, item 48), wherein the inner structural layer (figure 11, item 46) has a compliance from about 4% to about 7% (paragraph [0046]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Beyar and Devens, Jr., to have an inner structural layer with a compliance from about 4% to about 7%, as taught by Pendleton, as applicant appears to have placed no criticality on the claimed range and since it has been held to “in the case where the ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
[Claim 25] Beyar, Devens, Jr., and Pendleton, teach the limitations of claim 24, upon which claim 25 depends. Beyar does not specifically disclose the inner structural layer has a shore hardness that is less than a shore hardness of the outer structural layer.
However, Devens, Jr. teaches the layers may be of progressively increasing hardness from the innermost layer to the outermost layer (column 7, lines 13-18).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Beyar, Devens, Jr., and Pendleton, such that the inner structural layer has a shore hardness that is less than a shore hardness of the outer structural layer, as taught by Devens, Jr., in order to provide increased control and safety, by allowing for a means by which the outer layer of the balloon might be less susceptible to damage and/or rupture during delivery of therapy.
Claims 29, 33, and 34, are rejected under 35 U.S.C. 103 as being unpatentable over Beyar et al. (PGPub 2006/0190022), in view of Devens, Jr. et al. (USPN 9,180,620), in further view of Gianotti et al. (PGPub 2013/0253467).
[Claims 29 and 33] Beyar and Devens, Jr. teach the limitations of claim 21, upon which claims 29 and 33 depend. Beyar and Devens, Jr. do not specifically disclose the inner structural layer has a tensile elongation at break point that is greater than a tensile elongation at break point of the outer structural layer.
However, Gianotti teaches a medical balloon (figure 23a, item 140) comprising an inner structural layer (figure 23a, item 31) and an outer structural layer (figure 23a, item 30) (paragraph [0144]), wherein the inner structural layer (figure 23a, item 31) has a tensile elongation at break point that is greater than a tensile elongation at break point of the outer structural layer (figure 23a, item 30) (paragraph [0150]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Beyar and Devens, Jr., to have an inner structural layer have a tensile elongation at break point that is greater than a tensile elongation at break point of the outer structural layer, as taught by Gianotti, in order to provide increased functionality and control, by allowing for a means by which the geometry of the outer balloon might be maintained during inflation, thereby providing precision during the application of treatment.
[Claim 34] Beyar, Devens, Jr., and Gianotti, teach the limitations of claim 33, upon which claim 34 depends. Beyar, Devens, Jr., and Gianotti, do not specifically disclose the tensile elongation at break of the inner structural layer is at least 350% greater than the tensile elongation at break of the outer structural layer.
However, Gianotti discloses the teaching of a balloon wherein the tensile elongation of layers increases from the outermost layer inward (“each layer is typically about 10% to about 50%, and more specifically about 20% more than the elongation of the outer layer immediately adjacent thereto”) (paragraph [0150]), such that the tensile elongation is a result effective variable for controlling the geometry of the balloon during inflation.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the inner structural layer with a tensile elongation as claimed as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Beyar et al. (PGPub 2006/0190022), in view of Devens, Jr. et al. (USPN 9,180,620), in further view of Stupecky et al. (PGPub 2007/0167973).
[Claim 37] Beyar and Devens, Jr. teach the limitations of claim 36, upon which claim 37 depends. Beyar and Devens, Jr. do not specifically disclose a lubricant between the inner structural layer and the outer structural layer to promote sliding between the inner structural layer and the outer structural layer.
However, Stupecky teaches a medical balloon (figure 21, not labeled) comprising an inner structural layer (figure 21, item 15) and an outer structural layer (figure 21, item 16), wherein a lubricant (figure 21, item 18) between the inner structural layer (figure 21, item 15) and the outer structural layer (figure 21, item 16) promotes sliding between the inner structural layer (figure 21, item 15) and the outer structural layer (figure 21, item 16) (paragraph [0111]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Beyar and Devens, Jr., to have a lubricant between the inner structural layer and the outer structural layer, as taught by Stupecky, in order to provide increased control and safety, by allowing for a means by which friction between layers might be reduced, preventing unequal distribution of stress, and thereby preventing premature failure (Stupecky; paragraph [0111]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 11/12/2025