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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 10/15/2025.
Status of the claims:
Claims 1 – 5 and 8 – 15 are pending in the application.
Claims 1 – 5 and 8 – 15 are amended.
Claim Objections
The objections to claims 1 – 15 in the previous action dated 07/29/2025 have been withdrawn in light of the Applicant’s amendments filed 10/15/2025. Specifically, the objection to claim 1 regarding the phrases “a first distal end portion”, “a second distal end portion”, “a first proximal end portion”, “a second proximal end portion”, “an end portion of the distal end connecting portion connected to the inflatable portion”, “the end portion”, “an end portion of the proximal end connecting portion connected to the inflatable portion”, “to the inflatable portion”, “towards an inner side”, and “towards an outer side”, and the objections to claims 2 – 15 regarding the phase “a catheter” have been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below in light of applicant’s amendments.
Claim 1 is objected to because of the following informalities:
Claim 1 recites “the first distal end portion of the inflatable portion” in line 29 and “the first proximal end portion of the inflatable portion” in line 32, although the lines do not rise to the level of being indefinite and are understood by the Examiner to mean “the first distal end portion of the balloon” and “the first proximal end portion of the balloon”, as previously defined, the Examiner suggests the lines be amended to read “the first distal end portion of the balloon” and “the first proximal end portion of the balloon” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5 and 11 – 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites wherein “the inner side thick film portion extends along the extending direction from the second distal end portion to the second proximal end portion” and Claim 5, which depends on claim 1, recites “the outer side thick film portion is closer than the inner side thick film portion to the first proximal end portion.”, although Applicant’s disclosure has support for the inner side thick film portion extending along the extending direction (i.e., longitudinally) from the second distal end portion to the second proximal end portion (see Specification paragraphs [0038 – 0044] and Fig. 2), and separately, has support for the outer side thick film portion is closer than the inner side thick film portion to the first proximal end portion (see Specification paragraphs [0074 – 0077] and Fig. 5), Applicant’s disclosure does not have support for a balloon comprising the inner side thick film portion extending from distal end to proximal end of the balloon and the thick film portion being closer than the inner side thick film portion to the proximal end of the balloon. Therefore, Claim 5 is rejected for failure to comply with the written description requirement.
Claim 1 recites wherein “the inner side thick film portion extends along the extending direction from the second distal end portion to the second proximal end portion” and Claim 11, which depends on claim 1, recites “the inner side thick film portion is an annular shape extending along a circumferential direction centered on the center axis”, although Applicant’s disclosure has support for the inner side thick film portion extending along the extending direction (i.e., longitudinally) from the second distal end portion to the second proximal end portion (see Specification paragraphs [0038 – 0044] and Fig. 2), and separately, has support for the inner side thick film portion is an annular shape extending along a circumferential direction centered on the center axis (see Specification paragraphs [0048 – 0053], [0090 – 0095], Figs. 3 and 7), Applicant’s disclosure does not provide support for the inner side thick film portion extending along the entire length of the balloon and being annular in shape. Therefore, Claim 11 is rejected for failure to comply with the written description requirement.
Claim 1 recites wherein “the inner side thick film portion extends along the extending direction from the second distal end portion to the second proximal end portion” and Claim 12, which depends on claim 1, recites “wherein the inner side thick film portion is a helical shape extending along a circumferential direction centered on the center axis, and is provided between the first distal end portion and the first proximal end portion.”, although Applicant’s disclosure has support for the inner side thick film portion extending along the extending direction (i.e., longitudinally) from the second distal end portion to the second proximal end portion (see Specification paragraphs [0038 – 0044] and Fig. 2), and separately, has support for the inner side thick film portion is helical shape extending along the circumferential direction (see Specification paragraphs [0055 – 0057] and Fig. 4), Applicant’s disclosure does not provide support for the inner side thick film portion extending along the entire length of the balloon and being helical in shape. Therefore, Claim 12 is rejected for failure to comply with the written description requirement.
Claims 13 – 15 are rejected for being dependent on a claim rejected under 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.
The rejection of claims 2, 5, 9, 10, and 15 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 07/29/2025 have been withdrawn in light of the Applicant’s amendments filed 10/15/2025. Specifically, the rejection of claim 2, regarding the lack of clarity in the phrase “an outer diameter”, the rejection of claims 9, 10, and 15, regarding the phrase "the plurality of slits", and the rejection of claim 5 for being dependent on an indefinite claim have been withdrawn
Claims 1 – 15 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.
Regarding claim 1, the phrase " a distal end connecting portion being a portion extending from a first distal end portion of the balloon that is on one side in the extending direction of the inflatable portion, to the opposite side of the inflatable portion, a diameter of a third proximal end portion of the distal end connecting portion connected to the inflatable portion being larger than a diameter of a second distal end portion of the balloon that is an end portion on the opposite side from the third proximal end portion connected to the inflatable portion;" renders the claim indefinite because it is unclear if Applicant is intending for the “distal end connecting portion” to extend along the length of the “inflatable portion” (i.e., from a first distal end portion of the balloon that is one side of the inflatable portion to the opposite side of the inflatable portion) which is defined as having a tubular shape (i.e., not tapered) or if Applicant is intending for the distal end connecting portion to extend from a first distal end portion of the inflatable portion to a second distal end portion of the balloon, wherein the third proximal end portion of the balloon is the same as the first distal end portion of the inflatable portion. For the purpose of examination, the Examiner will read the claim to mean that the distal end connecting portion extends, and tapers, from the distal end of the inflatable portion (i.e., the first distal end portion) to the distal end of the balloon (i.e., the second distal end portion).
Regarding claim 1, the phrase “a proximal end connecting portion being a portion extending from a first proximal end portion of the balloon that is an end portion on another side in the extending direction of the inflatable portion,” renders the claim indefinite because it is unclear where the “proximal end connecting portion” is extending to. For the purpose of examination, the Examiner will read the claim to mean that the proximal end connecting portion extends, and tapers, from the proximal end of the inflatable portion (i.e., the first proximal end portion) to the proximal end of the balloon (i.e., the second proximal end portion).
Regarding claim 5, the phrase " the outer side thick film portion is closer than the inner side thick film portion to the first proximal end portion." renders the claim indefinite because it is unclear how the outer side thick film portion can be closer to the first proximal end portion than the inner side thick film portion, as claim 1 requires the inner side thin film portion extend from the first distal end to the second proximal end, which encompasses the inner side thick film portion extending through the first proximal end portion.
Claims 2 – 5 and 8 – 15 are rejected for being dependent on an indefinite claim.
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.
Claims 3, 4, and 13 are 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 3 recites “wherein the inner side thick film portion extends along the extending direction”, Claim 4 recites “the inner side thick film portion is provided at the inflatable portion, and extends along the extending direction from the4 first distal end portion to the first proximal end portion”, and Claim 13 recites “the inner side thick film portion is provided between the second distal end portion and the second proximal end portion”, however, Claim 1 recites “the inner side thick film portion extends along the extending direction from the second distal end portion to the second proximal end portion” which encompasses the language of claims 3, 4, and 13; therefore, claims 3, 4, and 13 fail to limit the subject matter from which they depend. 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 1 – 4 are rejected under 35 U.S.C. 103 as being unpatentable over Steese-Bradley (US 6,544,224 A1).
Regarding claim 1, Steese-Bradley discloses a balloon (balloon 117) for a catheter (catheter 10) (abstract, col. 2 lines 34 – 47, col. 4 lines 10 – 24, col. 5 lines 35 – 61, and Fig. 6) comprising:
an inflatable portion (working length 121, central portion of the balloon 117; shown in Fig. 1 as ‘working length 21’ and designated in annotated Fig. 3) having a tube shape and extending in an extending direction (col. 5 lines 35 – 61, and Figs. 1,6);
a distal end connecting portion being a portion extending from a first distal end portion (see annotated Fig. 3), that is an end portion on one side in the extending direction of the inflatable portion (see annotated Fig. 3), to the opposite side to the inflatable portion (see annotated Fig. 3), a diameter of an end portion of the distal end connecting portion connected to the inflatable portion being larger than a diameter of a second distal end portion that is an end portion on the opposite side from the end portion connected to the inflatable portion (see annotated Fig. 3); and
a proximal end connecting portion being a portion extending from a first proximal end portion (see annotated Fig. 3), that is an end portion on another side in the extending direction of the inflatable portion (see annotated Fig. 3), a diameter of an end portion of the proximal end connecting portion connected to the inflatable portion being larger than a diameter of a second proximal end portion that is an end portion on the opposite side from the end portion connected to the inflatable portion (see annotated Fig. 3), wherein
the balloon (balloon 117) for the catheter includes an inner side thick film portion (lobe portions 122; designated in annotated Fig. 6) and a thin film portion (balloon surface 125; designated in annotated Fig. 6) having differing thicknesses from each other (see annotated Fig. 6) (col. 5 lines 35 – 61),
the thickness of the inner side thick film portion is greater than the thickness of the thin film portion (see annotated Fig. 6) (col. 5 lines 35 – 61),
an inner surface at the inner side thick film portion protrudes further toward an inner side than an inner surface at the thin film portion (see annotated Fig. 6), in a radial direction centered on a center axis extending in the extending direction and passing through a center of the inflatable portion (see annotated Fig. 6) (col. 5 lines 35 – 61) (Examiner’s note: as shown in annotated Fig. 6 the lobe portions 122 extend radially inward past the thin film portion inner surface), and
an outer surface at the inner side thick film portion does not protrude further to an outer side in the radial direction than an outer surface at the thin film portion (see annotated Fig. 6) (Examiner’s note: as shown in annotated Fig. 6 the outer surface at the location of the lobe portions 122 (i.e., the thick film portion) is radially aligned with the outer surface at the thin film portions),
wherein the inner side thick film portion (lobe portions 122) is provided at the inflatable portion (col. 5 lines 35 – 61), the distal end connecting portion, and the proximal end connecting portion (Examiner’s note: as stated in col. 2 lines 34 – 47 the lobe portions extend into the tapered portions (i.e., the distal and proximal connecting portions – see annotated Fig. 3)),
wherein the thickness of the inner side thick film portion (lobes 122) of the distal end connecting portion becomes thinner from the portion connected to the first distal end portion of the inflatable portion toward the second distal end portion and the thickness of the inner side thick film portion of the proximal end connecting portion becomes thinner from a portion connected to the first proximal end portion of the inflatable portion toward the second proximal end portion (Examiner’s note: as stated in col. 2 lines 34 – 47 the lobed sections include a stepped smaller diameter section proximal and distal to the working length. It should be understood that the first distal and proximal end portions are at the end of the working length (i.e., the inflatable portion), and the thickness of the lobe portions (i.e., the inner side thick film portions) at the first distal and proximal end portions are the same thickness as the thickness of the lobe portions (i.e., the inner side thick film portions) at the working length (i.e., the inflation portion); and because Steese-Bradley recites that the smaller diameter section (i.e., thickness) of the lobe portions proximal and distal to the working length (i.e., the inflatable portion / first end portions) is smaller than the thickness of the lobe portions at the working length (i.e., the inflatable portion), and thus the first end portions, then the thicknesses of the lobe portions (i.e., the inner side thick film portions) become smaller towards the second end portions as claimed. Additionally, the claims as currently written do not require a taper or a gradual decrease in thickness, the claims only require that the thick film portion become thinner at some point along the length thereof).
However, Steese-Bradley is silent regarding (i) the inner side thick film portion extends along the extending direction from the second distal end portion to the second proximal end portion.
As to the above, Steese-Bradley teaches wherein the inner side thick film potion (lobe portions 122; designated in Fig. 6) can be in at least a portion of the tapered portions at both ends, the tapered portions are the proximal and distal connecting portions (see annotated Fig. 3). Although Steese-Bradley does not explicitly state that the inner side thick film portions (lobe portions 122) extend to the second end portions it would have been prima facie obvious to a person of ordinary skill in the art to modify the length of the inner side thick film portions (lobe portions 122) to extend to the second end portions (i.e., extending from the second proximal end portion to the second distal end portion) as claimed as there are finite options to choose from when determining the amount of extension of the inner side thick film portions within distal and proximal connection portions (i.e., the tapered portions) starting from the first end portions (distal and proximal) in order to provide optimal profile of the balloon, the options are: 1) from the first end portion to the second end portion (as claimed) and 2) from the first end portion to some point in between the first end portion and the second end portion. and it has been held that “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007). Therefore, it would have been obvious to try having the inner side thick film portions (lobe portions 122) extend all of the way to the second end portions of each connecting end portion (i.e., extending from the second proximal end portion to the second distal end portion) as claimed, in order to obtain the desired / optimal balloon profile. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rationale E, outlined in MPEP 2143. 26
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Annotated Figure 3 of Steese-Bradley
Annotated Figure 6 of Steese-Bradley
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Regarding claim 2, Steese-Bradley discloses wherein an outer diameter, being a distance in the radial direction from the center axis to the outer surface, is the same at the thin film portion and at the inner side thick film portion (Examiner’s note: as shown in annotated Fig. 6 the outer diameter of the thin film portion and the inner side thick film portion is the same), and an inner diameter, being a distance in the radial direction from the center axis to the inner surface, is smaller at the inner side thick film portion than at the thin film portion (Examiner’s note: as shown in annotated Fig. 6 because the lobe portions 122 (i.e., the thick film portions) protrude toward the central axis, the inner diameter of the thick film portion is smaller than the inner diameter at the thin film portions).
Regarding claim 3, Steese-Bradley discloses wherein the inner side thick film portion (lobe portions 122) extends along the extending direction (col. 2 lines 34 – 47).
Regarding claim 4, Steese-Bradley discloses wherein the inner side thick film portion is provided at the inflatable portion (col. 5 lines 35 – 61), and the inner side thick film portion extends along the extending direction from the first distal end portion to the first proximal end portion (Examiner’s note: as stated in col. 2 lines 34 – 47 the lobe portions extend into the tapered portions which are the distal and proximal connecting portions – see annotated Fig. 3, therefore the lobe portions extend into the distal and proximal connection portions, which means that the lobe portions extend proximally past the first proximal end and distally past the first distal end, thus the lobe portions extend from the first proximal end portion to the first distal end portion).
Allowable Subject Matter
Claims 8 – 10 are 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.
Response to Arguments
Applicant’s arguments, filed 10/15/2025, with respect to the rejection of claim 1 under Weber and, separately, under Rentschler have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because neither Weber or Rentschler teach wherein the inner thick film portion extend, in the longitudinal direction, the entire length of the balloon.
Applicant's arguments filed 10/15/2025, with respect to the rejection of claim 1 under Steese-Bradley have been fully considered but they are not persuasive. More specifically:
Regarding Applicant’s argument that “Steese-Bradley does not disclose or suggest the relative thicknesses of either the inner side thick film portions of the distal end connecting portion or the proximal end connecting portion with respect to the thickness of the inner side thick film portion of the inflatable portion”, as stated in the rejection above, Steese-Bradley teaches wherein the diameter of the loped portion in the tapered portions (i.e., the proximal and distal connecting portions) is stepped, therefore the thickness of the lobed portion (i.e., the inner side thickness portion) becomes thinner from the inflatable portion toward the distal / proximal ends of the balloon. The Examiner notes that the claim as currently written does not require the thickness to be continuously tapered.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Steese-Bradley has no appreciation for and does not contemplate the aforementioned effect or the problem that the amended claim 1 combination addresses with the particular claimed features set forth above.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771