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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 02/17/2026 is acknowledged. The traversal is on the ground(s) that the inventions have unity of invention as they are drawn only to “a product and a process specifically adapted for the manufacture of the product”. This is not found persuasive because while Group I is directed to a product and Group II is directed to a process for manufacturing a product, Group II is not directed to a process specifically adapted for the manufacture of the product of Group I. For example, the method does not appear to form a catheter that has a connection tube protruding from the inflation opening and protruding into the interior of the balloon.
The requirement is still deemed proper and is therefore made FINAL.
Claims 74-78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/17/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “3” has been used to designate both the distal end and the distal region. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 69 is 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 69 recites the limitation "the conduit" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, this claim is interpreted as depending upon Claim 67.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 59, 61, 63, and 67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torres et al (US 2019/0083757).
Regarding Claim 59, Torres discloses a catheter (100, Fig. 1) comprising:
a shaft (110, Fig. 1) having a proximal region (120, Fig. 1; the proximal half of the catheter) and a distal region (130, Fig. 1; the distal half of the catheter), the distal region (130, Fig. 1; the distal half of the catheter) terminating in a tip (270, Fig. 1);
a balloon (140, Fig. 1) located at a distal end (130, Fig. 1) of the shaft (110, Fig. 1);
an inflation opening (end of midshaft member 520, Fig. 1) located in the distal region (130, Fig. 1; distal half of the catheter; ¶ [0053] indicates 520 is a midshaft member so the distal half of the midshaft member would be considered in the distal region/distal half of the catheter as a whole) of the shaft (110, Fig. 1), the inflation opening (end of 520, Fig. 1) communicating with an inflation lumen (201, Fig. 1) of the shaft (110, Fig. 1);
a connection tube (230, Fig. 1) located in the distal region (130, Fig. 1; distal half of the catheter) of the shaft (110, Fig. 1), the connection tube (230, Fig. 1) communicating with the inflation opening (end of 520, Fig. 1) and the interior of the balloon (140, Fig. 1; as seen in Fig. 1, the tube 230 is within the proximal shaft of the balloon and therefore in the interior of the balloon);
wherein the connection tube (230, Fig. 1) protrudes from the inflation opening (opening of 520, Fig. 1) and protrudes into the interior of the balloon (140, Fig. 1; as seen in Fig. 1, the tube 230 is within the proximal shaft of the balloon and therefore in the interior of the balloon).
Regarding Claim 61, Torres discloses the interior of the balloon (140, Fig. 1) is secured to the connection tube (230, Fig. 1; ¶ [0078]).
Regarding Claim 63, Torres discloses at least a part of the connection tube (230, Fig. 1) is located inside the inflation lumen (201, Fig. 1).
Regarding Claim 67, Torres discloses the balloon (140, Fig. 1) comprises a first region (145, Fig. 1) secured to the connection tube (230, Fig. 1), a second region (141, Fig. 1) secured to the shaft (110, Fig. 1) and an elastic-walled and/or flexible-walled conduit (143, Fig. 1) extending between the first region (145, Fig. 1) and the second region (141, Fig. 1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 60, 62, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Torres et al (US 2019/0083757).
Regarding Claim 60, Torres is silent whether the connection tube protrudes at least 2mm from the inflation opening.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Torres to have the connection tube protrude at least 2mm from the inflation opening since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Torres would not operate differently with the claimed protrusion distance and the device would function appropriately with the claimed protrusion distance. Further, applicant places no criticality on the range claimed, indicating simply that the protrusion distance is “preferably” within the claimed ranges (¶ [0170] of published specification).
Regarding Claim 62, Torres is silent whether the connection tube protrudes into the interior of the balloon by at least 2mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Torres to have the connection tube protrude into the interior of the balloon by at least 2mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Torres would not operate differently with the claimed protrusion distance and the device would function appropriately with the claimed protrusion distance. Further, applicant places no criticality on the range claimed, indicating simply that the protrusion distance is “preferably” within the claimed ranges (¶ [0170] of published specification).
Regarding Claim 64, Torres is silent whether the connection tube extends into the inflation lumen by at least 2mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Torres to have the connection tube extend into the inflation lumen by at least 2mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Torres would not operate differently with the claimed protrusion distance and the device would function appropriately with the claimed protrusion distance. Further, applicant places no criticality on the range claimed, indicating simply that the protrusion distance is “preferably” within the claimed ranges (¶ [0171] of published specification).
Claim(s) 59 and 65-73 are rejected under 35 U.S.C. 103 as being unpatentable over Harvard et al (WO 2018/134591) in view of Torres et al (US 2019/0083757).
Regarding Claim 59, Harvard discloses a catheter (Figs. 1 and 4) comprising:
a shaft (1, Figs. 1 and 4) having a proximal region (2, Figs. 1 and 4) and a distal region (3, Figs. 1 and 4), the distal region (3, Figs. 1 and 4) terminating in a tip (4, Figs. 1 and 4);
a balloon (12, Figs. 1 and 4) located at a distal end (4, Figs. 1 and 4) of the shaft (1, Figs. 1 and 4);
an inflation opening (5, Figs. 1 and 4) located in the distal region (3, Figs. 1 and 4) of the shaft (1, Figs. 1 and 4), the inflation opening (5, Figs. 1 and 4) communicating with an inflation lumen (6, Figs. 1 and 4) of the shaft (1, Figs. 1 and 4).
Harvard is silent regarding a connection tube located in the distal region of the shaft, the connection tube communicating with the inflation opening and the interior of the balloon, wherein the connection tube protrudes from the inflation opening and protrudes into the interior of the balloon.
Torres teaches a catheter, thus being in the same field of endeavor, with a connection tube (230, Fig. 1) located in the distal region (130, Fig. 1) of the shaft (110, Fig. 1), the connection tube (230, Fig. 1) communicating with the inflation opening (opening of 520, Fig. 1) and the interior of the balloon (140, Fig. 1), wherein the connection tube (230, Fig. 1) protrudes from the inflation opening (opening of 520, Fig. 1) and protrudes into the interior of the balloon (140, Fig. 1). This provides a secure inflation path between the inflation lumen/opening and the interior of the balloon, as both ends of the connection tube are bonded to the inflation lumen and the interior of the balloon (¶ [0067-0069]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Harvard to include a connection tube located in the distal region of the shaft, the connection tube communicating with the inflation opening and the interior of the balloon, wherein the connection tube protrudes from the inflation opening and protrudes into the interior of the balloon, as taught by Torres, to provide a secure inflation path between the inflation lumen/opening and the interior of the balloon, as both ends of the connection tube are bonded to the inflation lumen and the interior of the balloon (as motivated by Torres ¶ [0067-0069]).
Regarding Claim 65, Harvard further discloses the shaft (1, Figs. 1 and 4) comprises a first shoulder in the distal region (3, Figs. 1 and 4) of the shaft (1, Figs. 1 and 4), the first shoulder being recessed relative to the external diameter of the shaft (1, Figs. 1 and 4; page 18 final paragraph indicates that the outer surface of the catheter shaft may define a recess for the uninflated balloon to sit, and this recess can be considered a first shoulder on the top side of the catheter).
Regarding Claim 66, Harvard further discloses the inflation opening (5, Figs. 1 and 4) is located on the first shoulder of the shaft (1, Figs. 1 and 4; page 18 final paragraph indicates that the outer surface of the catheter shaft may define a recess for the uninflated balloon to sit, and this recess can be considered a first shoulder on the top side of the catheter).
Regarding Claim 67, Harvard further discloses the balloon (12, Figs. 1 and 4) comprises a first region (end 13, Fig. 4), a second region (end 22, Fig. 4) secured to the shaft (1, Figs. 1 and 4) and an elastic-walled and/or flexible-walled conduit (majority of balloon 12, Fig. 4) extending between the first region (13, Fig. 4) and the second region (22, Fig. 4). The combination of Harvard/Torres set forth above for Claim 59 will have the first region secured to the connection tube of Harvard/Torres.
Regarding Claim 68, Harvard further discloses the shaft (1, Figs. 1 and 4) comprises a first shoulder in the distal region (3, Figs. 1 and 4) of the shaft (1, Figs. 1 and 4), the first shoulder being recessed relative to the external diameter of the shaft (1, Figs. 1 and 4; page 18 final paragraph indicates that the outer surface of the catheter shaft may define a recess for the uninflated balloon to sit, and this recess can be considered a first shoulder on the top side of the catheter), and wherein the shaft (1, Figs. 1 and 4) comprises a second shoulder on an opposing side of the shaft (1, Figs. 1 and 4) to the first shoulder (page 18 final paragraph indicates that the outer surface of the catheter shaft may define a recess for the uninflated balloon to sit, and this recess can be considered a first shoulder on the top side of the catheter and a second shoulder on the bottom side of the catheter).
Regarding Claim 69, Harvard further discloses the conduit (majority of balloon 12, Fig. 4) extends over the tip (4, Fig. 4) of the shaft (1, Figs. 1 and 4).
Regarding Claim 70, Harvard further discloses a drainage opening (7, Fig. 4) located at the distal end (3, Figs. 1 and 4) of the shaft (1, Figs. 1 and 4), the drainage opening (7, Fig. 4) communicating with a drainage lumen (8, Figs. 1 and 4) of the shaft (1, Figs. 1 and 4).
Regarding Claim 71, Harvard further discloses the drainage opening (7, Fig. 4) of the shaft (1, Figs. 1 and 4) is located on a side of the shaft (1, Figs. 1 and 4; page 3, paragraph 6).
Regarding Claim 72, Harvard further discloses the balloon (12, Figs. 1 and 4) comprises a first region comprises a first region (end 13, Fig. 4), a second region (end 22, Fig. 4) secured to the shaft (1, Figs. 1 and 4) and an elastic-walled and/or flexible-walled conduit (majority of balloon 12, Fig. 4) extending between the first region (13, Fig. 4) and the second region (22, Fig. 4), and wherein at least part of the first region (13, Fig. 4) and at least part of the second region (22, Fig. 4) are located proximally of the drainage opening (7, Fig. 4). The combination of Harvard/Torres set forth above for Claim 59 will have the first region secured to the connection tube of Harvard/Torres.
Regarding Claim 73, Harvard further discloses the catheter is an indwelling urinary catheter configured to be retained in the bladder of a patient (page 1, paragraphs 1-2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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, Sarah Al-Hashimi can be reached at 571-272-7159. 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.
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
Prosecution Insights