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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/05/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 02/05/2026.
Status of the claims:
Claims 1 and 4 – 7 are pending in the application.
Claim 1 is amended.
Claim Objections
The objections to claims 6 and 7 in the previous action dated 10/08/2025 have been withdrawn in light of the Applicant’s amendments filed 01/07/2026. Specifically, the objection to claim 6, regarding the phrase “the proximal end portion of the proximal end portion expansion lumen” and the objection to claim 7 regarding the phrase “a proximal end side of the shaft”, have been withdrawn as the appropriate corrections have been made or the claims have been cancelled.
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:
the generic placeholder is a “expansion resistance structure” in claim 1, which is coupled to the functional language “configured to give resistance to expansion to the balloon”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “expansion resistance structure” in claim 1 will be read as a strong molded portion of the balloon or a portion of the balloon with a applied meshing, friction, or adhesive (which is the disclosed corresponding structure, as described in paragraph [0046] of the instant specification) or an equivalent structure (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way).
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 § 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.
The rejections of claims 1 and 5 – 7 under U.S.C 35 103 with respect to Tsutsui in view of Chanduszko, recited in the previous action dated 10/08/2025 have been withdrawn in light of the Applicant’s amendments filed 01/07/2026. Specifically, the rejection of claim 1 under Tsutsui and Chanduszko has been withdrawn because the combination does not disclose or make obvious wherein the diameter of intermediate portion of the balloon in the folded state is smaller than that of the proximal end portion and the distal end portions of the balloon in the folded state. However, a new rejection has been set forth below under Onishi and Chanduszko; wherein Onishi is relied upon for teaching the limitation above.
Claims 1 and 4 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Onishi et al (US 2018/0153536 A1) in view of Chanduszko et al (WO 2014/055514 A2) (previously cited) (cited PDF attached – the page number cited to is the page number of the PDF, where the cover page is page 1).
Regarding claims 1 and 5, Onishi discloses a balloon catheter (endoscope 1 with balloon 3) (abstract, paragraphs [0024 – 0025], and Figs. 1 – 13) comprising:
a shaft (sheath 2) that extends in an axial direction from a proximal end side to a distal end side (paragraph [0025] and Figs. 1,2,7); and
a balloon (balloon 3) that is attached to the distal end side of the shaft and is expandable by a fluid supplied from the proximal end side of the shaft (paragraphs [0025], [0029], and Figs. 1,7), a proximal end portion expansion lumen (passage 41) for supplying the fluid to, and [claim 5] terminating at, a proximal end portion inside balloon (balloon 3) (paragraph [0025] an Fig. 1) (Examiner’s note: as shown in Fig. 1 the lumen ends at the proximal end portion of the balloon);
wherein an intermediate portion (intermediate section 33) of the balloon between a distal end portion of the balloon (first region 31) and a proximal end portion of the balloon (second region 32) is provided with an expansion resistance structure (intermediate section 33) that gives a larger resistance to an expansion pressure caused by the fluid than the distal end portion of the balloon and the proximal end portion of the balloon (paragraph [0033], [0037 – 0039], [0040 – 0042], [0046 – 0047], and Figs. 2,9,13) (Examiner’s note: as stated in paragraphs [0042 – 0047] the residual strain in the intermediate section 33 causes a larger resistance to expansion than first and second regions 31,32 (i.e., the distal and proximal portions). Additionally, as stated in the 112(f) claim interpretation section above, the term “expansion resistance structure” is being interpreted as a portion of the balloon that is formed to have an expansion resistance larger than other portions of the balloon, and as stated above the intermediate section 33 is formed to have a larger expansion resistance than the other parts of the balloon. Therefore, the intermediate section 33 is seen as an equivalent structure to the claimed “expansion resistance structure”);
wherein, in the expansion resistance structure (intermediate section 33), a diameter of the intermediate portion of the balloon is smaller than a diameter of the distal end portion of the balloon (first region 31) and a diameter of the proximal end portion of the balloon (second region 32) in a folded state in which the balloon is wrapped around the shaft (sheath 2) to form a completely contracted shape of the balloon before the fluid is supplied to the balloon (paragraphs [0033 – 0037] and Fig. 2).
However, Onishi et al is silent regarding [claims 1 and 5] (i) wherein a portion of the shaft internally includes a distal end portion expansion lumen for supplying the fluid to, and terminating at, a distal end space inside the balloon and the proximal end portion expansion lumen for supplying the fluid to a proximal end space inside the balloon.
As to the above, Chanduszko teaches, in the same field of endeavor, a balloon catheter (-catheter 10 with a balloon 12) (abstract, pg. 8 lines 15 – 28, pg. 9 line 11 – pg. 10 line 31, and Fig. 1) comprising a shaft (outer shaft 14 with inflation lumens 16a/b and tubes 18a/b) and a balloon (balloon 12) that is attached to the distal end side (attachment location of the balloon (12a) to the end of tube 18b) of the shaft (outer shaft 14) (Fig. 1) wherein a portion of the shaft internally includes a distal end portion expansion lumen (inflation lumen 16b/tube 18b) for supplying the fluid to (and terminating at) a distal end portion in the balloon (distal end 12b) and a proximal end portion expansion lumen (inflation lumen 16a/tube 18a) for supplying the fluid to (and terminating at) a proximal end portion in the balloon (proximal end 12a) (pg. 10 lines 11 – 31 and Fig. 1) for the purpose of improving the inflation mechanics of the system (pg. 12 lines 29 – 30).
It should be understood that Onishi et al and Chanduszko are known references in the art that teach balloon catheters (abstract, paragraphs [0024 – 0025], and Figs. 1 – 13 – Onishi et al; abstract and pg. 3 line 28 – pg. 4 line 2 – Chanduszko); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one means of inflating a balloon with another, and the results of the substitution would have been predictable and resulted in the modified inflation system of Onishi et al being able to function as intended to properly inflate the balloon. 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), rational B, outlined in MPEP 2143. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Onishi et al to have the inflation system of Chanduszko, for the purpose of improving the inflation mechanics of the system (pg. 12 lines 29 – 30). It should be understood that the modification above is such that the proximal end portion expansion lumen (passageway 41) of Onishi et al is substituted for both of the expansion lumens (inflation lumen 16a,b / tube 18a,b) of Chanduszko which extend the length of the system.
Regarding claim 6, as discussed above, the combination of Onishi et al and Chanduszko discloses the device of claim 1 above. Additionally, the combination encompasses a fluid supply portion (connecting section 4 and inflator 200 of Onishi) that supplies fluid to the distal end and proximal end portion expansion lumens (inflation lumen 16a,b / tube 18a,b of Chanduszko) (paragraphs [0032] and [0049] of Onishi).
However, however the current combination of Onishi et al and Chanduszko does not expressly disclose (i) wherein the proximal end portion expansion lumen is formed to be longer than the distal end portion expansion lumen in the fluid supply portion that supplies the fluid to the distal end portion expansion lumen and a proximal end portion of the proximal end portion expansion lumen. With respect to (i), Chanduszko teaches, in pg. 11 line 27 – pg. 12 line 7 and pg. 12 lines 14 – 21, varying the length of the expansion lumens (inflation lumens 16a/b / tubes 18a/18b) to allow for the user to achieve the desired / optimal inflation profile.
As to the above, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the length of the proximal portion of the proximal end portion expansion lumen (inflation lumen 16a/tube 18a) to be longer in the fluid supply portion (in the proximal end side of the shaft) to be longer than that of the proximal portion of the distal end expansion lumen (inflation lumen 16b/tube 18b) as there are finite options to choose from when determining the relative lengths of the inflation tubes in order to provide the desired / optimal inflation profile, the options are: 1) the proximal end portion expansion lumen being longest, 2) the distal end portion expansion lumen being longest, or 3) the proximal and distal end portion expansion lumens are the same length; 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 a longer proximal portion of the proximal end portion expansion lumen (inflation lumen 16a/tube 18a) in order to obtain the desired / optimal expansion 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.
Regarding claims 1, 5, and 7, (alternate interpretation, changes have been italicized) Onishi discloses a balloon catheter (endoscope 1 with balloon 3) (abstract, paragraphs [0024 – 0025], and Figs. 1 – 13) comprising:
a shaft (sheath 2) that extends in an axial direction from a proximal end side to a distal end side (paragraph [0025] and Figs. 1,2,7); and
a balloon (balloon 3) that is attached to the distal end side of the shaft and is expandable by a fluid supplied from the proximal end side of the shaft (paragraphs [0025], [0029], and Figs. 1,7), a proximal end portion expansion lumen (passage 41) for supplying the fluid to, and [claim 5] terminating at, a proximal end portion inside balloon (balloon 3) (paragraph [0025] an Fig. 1) (Examiner’s note: as shown in Fig. 1 the lumen ends at the proximal end portion of the balloon);
wherein an intermediate portion (intermediate section 33) of the balloon between a distal end portion of the balloon (first region 31) and a proximal end portion of the balloon (second region 32) is provided with an expansion resistance structure (intermediate section 33) that gives a larger resistance to an expansion pressure caused by the fluid than the distal end portion of the balloon and the proximal end portion of the balloon (paragraph [0033], [0037 – 0039], [0040 – 0042], [0046 – 0047], and Figs. 2,9,13) (Examiner’s note: as stated in paragraphs [0042 – 0047] the residual strain in the intermediate section 33 causes a larger resistance to expansion than first and second regions 31,32 (i.e., the distal and proximal portions). Additionally, as stated in the 112(f) claim interpretation section above, the term “expansion resistance structure” is being interpreted as a portion of the balloon that is formed to have an expansion resistance larger than other portions of the balloon, and as stated above the intermediate section 33 is formed to have a larger expansion resistance than the other parts of the balloon. Therefore, the intermediate section 33 is seen as an equivalent structure to the claimed “expansion resistance structure”);
wherein, in the expansion resistance structure (intermediate section 33), a diameter of the intermediate portion of the balloon is smaller than a diameter of the distal end portion of the balloon (first region 31) and a diameter of the proximal end portion of the balloon (second region 32) in a folded state in which the balloon is wrapped around the shaft (sheath 2) to form a completely contracted shape of the balloon before the fluid is supplied to the balloon (paragraphs [0033 – 0037] and Fig. 2).
However, Onishi et al is silent regarding (i) [claims 1 and 5] wherein a portion of the shaft internally includes a distal end portion expansion lumen for supplying the fluid to (and terminating at) a distal end portion in the balloon and the proximal end portion expansion lumen for supplying the fluid to a proximal end portion in the balloon, and (ii) [claim 7] wherein a single expansion lumen through which the fluid supplied from a proximal end side of the shaft passes is provided at a proximal end side of the proximal end portion of the balloon in the shaft and communicating with the distal end portion expansion lumen and the proximal end portion expansion lumen at a distal end side of the proximal end portion of the balloon in the shaft.
As to the above, Chanduszko teaches, in the same field of endeavor, a balloon catheter (-catheter 10 with a balloon 12) (abstract, pg. 8 lines 15 – 28, pg. 9 line 11 – pg. 10 line 31, and Fig. 1) comprising a shaft (outer shaft 14 with inflation lumens 16a/b and tubes 18a/b), a balloon (balloon 12) that is attached to the distal end side (attachment location of the balloon (12a) to the end of tube 18b) of the shaft (outer shaft 14) (Fig. 1), and a single expansion lumen (separate inflation lumen 16) through which the fluid is supplied from a proximal portion of the shaft provided at a proximal end side of the proximal balloon in the shaft (pg. 11 lines 6 – 14 and Fig. 3), the single expansion lumen (separate inflation lumen 16) in communication with a portion of the shaft that internally includes a distal end portion expansion lumen (inflation lumen 16b/tube 18b) for supplying the fluid to (and terminating at) a distal end portion in the balloon (distal end 12b) and a portion of the shaft that internally includes a proximal end portion expansion lumen (inflation lumen 16a/tube 18a) for supplying the fluid to (and terminating at) a proximal end portion in the balloon (proximal end 12a) (pg. 10 lines 11 – 31 and Fig. 1) for the purpose of improving the inflation mechanics of the system (pg. 12 lines 29 – 30) (Examiner’s note: as stated on pg. 11 lines 6 – 14 the inflation lumen 16 separates into two lumens 16a and 16b (i.e., the distal end portion expansion lumen and the proximal end portion expansion lumen), therefore the inflation lumen 16 is in communication with the above as claimed).
It should be understood that Onishi et al and Chanduszko are known references in the art that teach balloon catheters (abstract, paragraphs [0024 – 0025], and Figs. 1 – 13 – Onishi et al; abstract and pg. 3 line 28 – pg. 4 line 2 – Chanduszko); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one means of inflating a balloon with another, and the results of the substitution would have been predictable and resulted in the modified inflation system of Onishi et al being able to function as intended to properly inflate the balloon. 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), rational B, outlined in MPEP 2143. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Onishi et al to have the inflation system of Chanduszko, for the purpose of improving the inflation mechanics of the system (pg. 12 lines 29 – 30 – Chanduszko). It should be understood that the modification above is such that the proximal end portion expansion lumen (passageway 41) of Onishi et al is substituted for the single expansion lumen (separate inflation lumen 16) which separates / splits into the two expansion lumens (inflation lumen 16a,b / tube 18a,b) of Chanduszko.
Response to Arguments
Applicant’s arguments, filed 02/05/2026, with respect to the rejection of claims 1 and 4 – 7 under Tsutsui and Chanduszko 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 the combination of Tsutsui and Chanduszko does not teach wherein the diameter of the intermediate portion of the balloon when the balloon is folded being smaller than the diameter of the end portions. It is noted that a new rejection has been made over Onishi and Chanduszko. The teachings of Onishi are relied upon for teaching the newly added limitations as discussed above.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771