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 and Species VI (associated with Figure 8) in the reply filed on 07/13/2026 is acknowledged. The traversal is on the ground(s) that there were typos in the species descriptions, Species IX (associated with Figure 11) & X (associated with Figure 12) are generic to all species, and sufficient reasoning for a serious burden has not been provided. This is not found persuasive because of the following reasons.
Regarding the typos in the species, Applicant should have been aware the species descriptions were merely a typo, and could have easily called Examiner for clarification. Even though the species names –i.e., Species I, II, III, IV, etc.— had typos, one of ordinary skill in the art would be able to reasonably determine how the respective species were being defined, especially with the associated figures.
Regarding the lack of sufficient reasoning for a serious burden, Examiner disagrees. A serious search burden has been established for each of the inventions and the species. Applicant argues a detailed explanation is required. However, Examiner has reviewed each of the pertinent MPEP sections, and there is no mention of the word “detailed”. As such, The Applicant’s intent with the argument is not clear to the Examiner. However, for clarity, a serious burden is established since, at the very least, searching for the number of expandable members, as well as branches of the catheter, or how the catheter is used requires different search terms, which significantly changes any search strategy for each specific invention/species.
Regarding Species IX (associated with Figure 11) & X (associated with Figure 12) are generic to all species, Applicant arguments are persuasive. As such, Examiner will interpret Applicant’s election as encompassing each of Figures 8, 11 & 12.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/13/2026.
Information Disclosure Statement
The Examiner notes that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing over 50 references for consideration. The Examiner has considered all of the references submitted as part of the Information Disclosure Statements, but has not found any to be of particular relevance. If Applicant is aware of pertinent material in the references, it should be stated in a response to this Office action. Applicant is reminded of MPEP § 2004, paragraph 13:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the initialed references have been considered in a cumulative manner. Examiner further notes that numerous cited references appear to have little or no relevance at all to the disclosed/claimed invention, many of which do not even mention the use of an expandable member.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-5 of U.S. Patent No. 12,017,022 (Craig). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
As to Claim 1, Craig teaches a catheter for local delivery of a liquid (the liquid drug solution) to a target tissue area of an internal body organ of a patient, the catheter comprising (Claim 1, Lines 18-20):
an elongate flexible shaft (Claim 1, Line 21);
an expandable member disposed about a distal region of the flexible shaft and being transformable between a collapsed delivery configuration and an expanded configuration for sealing against a wall of a natural lumen extending through the target tissue area to form a treatment chamber defined by the wall of the natural lumen distal of the expandable member (Claim 1, Lines 22-28);
a liquid ingress lumen extending from a proximal end of the elongate shaft to a liquid ingress port located distal to the expandable member (Claim 1, Lines 29-31); and
an egress lumen extending proximally through the elongate shaft from an egress port located distal to the expandable member (Claim 1, Lines 32-34);
wherein the egress port is covered by a gas-permeable membrane (Claim 1, Lines 35-37) that permits air to exit the treatment chamber (Claim 1, Line 38) and blocks the liquid (the liquid drug solution) when filling of the treatment chamber with the liquid (Claim 1, Lines 39-41).
As to Claim 2, Craig teaches each limitation of Claim 1, and continues to teach the egress lumen terminates proximally in an exhaust port disposed proximal to the expandable member (Claim 2).
As to Claim 3, Craig teaches each limitation of Claim 1, and continues to teach the egress port is located adjacent to the expandable member to facilitate the egress port being located at a high point of the formed treatment chamber with respect to gravity (Claim 3).
As to Claim 4, Craig teaches each limitation of Claim 1, and continues to teach the egress port is located very adjacent the expandable member (Claim 4).
As to Claim 5, Craig teaches each limitation of Claim 1, and continues to teach the expandable member is a compliant balloon inflatable to varying diameters, the elongate shaft further having an inflation lumen configured for inflating the compliant balloon (Claim 5).
Claim Objections
Claim 3 is objected to because of the following informalities.
Claim 3 should read --The catheter according to claim 1, wherein the egress port is located adjacent to the expandable memberintended use so does not differentiate the claimed apparatus from a prior art apparatus
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.
Claim 4 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.
As to Claim 4, the limitation “the egress port is located very adjacent the expandable member”, is indefinite. The term “very” is a relative term which renders the claim indefinite. The term “very” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, it is not clear how adjacent to the expandable member the egress needs to be to be considered “very adjacent”, rendering the claim indefinite. For the purpose of examination, the limitation will be interpreted as the egress port is located
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Dong (U.S. CN203264017U), in view of Thornton (U.S. Patent 6,102,931).
As to Claim 1, Dong teaches a catheter (Figure 2) for local delivery of a liquid (the irrigation liquid described in Paragraph 0012) to a target tissue area of an internal body organ of a patient (Paragraph 0011; intended use – see end of paragraph for clarification), the catheter (Figure 2) comprising:
an elongate flexible shaft (the shaft forming lumens 10/20/20, as viewed in Figure 2);
an expandable member (70) disposed about (as shown in Figure 2) a distal region (the top of the shaft, as viewed in Figure 2) of the flexible shaft (the shaft forming lumens 10/20/20, as viewed in Figure 2) and being transformable between a collapsed delivery configuration (Paragraph 0011, describes the balloon being expanded, which one of ordinary skill in the art would conclude inherently means the balloon is in a collapsed state before the balloon is expanded into an expanded state) and an expanded configuration (as shown in Figure 2) for sealing against a wall of a natural lumen extending through the target tissue area (as described in Paragraph 0011; intended use) to form a treatment chamber (the chamber formed by the distal side of balloon 70 and the walls of the natural lumen described in Paragraph 0011) defined by the wall of the natural lumen (the natural lumens described in Paragraph 0011) distal of (the top of 70, as viewed in Figure 2) the expandable member (70);
a liquid ingress lumen (30) extending from (as shown in Figure 2; Paragraph 0030) a proximal end (the bottom of the shaft, as viewed in Figure 2) of the elongate shaft (the shaft forming lumens 10/20/20, as viewed in Figure 2) to a liquid ingress port (31) located (as shown in Figure 2) distal to (the top of balloon 70, as viewed in Figure 2) the expandable member (70); and
an egress lumen (10) extending (as shown in Figure 2; Paragraph 0030) proximally through (down, as viewed in Figure 2) the elongate shaft (the shaft forming lumens 10/20/20, as viewed in Figure 2) from an egress port (11) located (as shown in Figure 2) distal to (the top of balloon 70, as viewed in Figure 2) the expandable member (70).
The intention to use the catheter in a selected manner or method is not a patentable limitation, as a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Also see MPEP 2115. Additionally, one of ordinary skill in the art would conclude the Don’t catheter may be used in the manner claimed, as evidenced by the end of Dong Paragraph 0011.
Dong continues describes allowing a lumen to drain or transport gases (Paragraph 0011), but does not teach the egress port is covered by a gas-permeable membrane that permits air to exit the treatment chamber and blocks the liquid when filling of the treatment chamber with the liquid.
Thornton describes a means for filtering gas/liquids in a balloon catheter, and teaches the egress port (22) is covered by a gas-permeable membrane (36; Column 4, Line 64, to Column 5, Line 7).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use a gas-permeable membrane, as taught by Thornton, in the egress port, as taught by Dong, to selectively allow gas through the port (Column 4, Line 64, to Column 5, Line 7).
Modifying Thornton into Dong results in permitting air to exit (Thornton Column 4, Line 64, to Column 5, Line 7) the treatment chamber (the Dong chamber formed by the distal side of Dong balloon 70 and the walls of the natural lumen described in Dong Paragraph 0011) and blocks (Thornton Column 4, Line 64, to Column 5, Line 7) the liquid (the irrigation liquid described in Dong Paragraph 0012) when filling (Dong Paragraph 0012) of the treatment chamber (the Dong chamber formed by the distal side of Dong balloon 70 and the walls of the natural lumen described in Dong Paragraph 0011) with the liquid (the irrigation liquid described in Dong Paragraph 0012).
As to Claim 2, Dong, as modified, teaches all the limitations of Claim 1, and continues to teach the egress lumen (Dong 10) terminates (as shown in Dong Figure 2) proximally (down, as viewed in Dong Figure 2) in an exhaust port (the port at the bottom of Dong lumen 10, as viewed in Dong Figure 2) disposed proximal to (below 70, as viewed in Dong Figure 2) the expandable member (Dong 70).
As to Claim 3, Dong, as modified, teaches all the limitations of Claim 1, and continues to teach the egress port (Dong 11) is located adjacent to (as shown in Dong Figure 2) the expandable member (Dong 70) to facilitate the egress port (Dong 11) being located at a high point (as shown in Dong Figure 2) of the formed treatment chamber (the Dong chamber formed by the distal side of Dong balloon 70 and the walls of the natural lumen described in Dong Paragraph 0011) with respect to gravity (up, as viewed in Dong Figure 2).
As to Claim 4, Dong, as modified, teaches all the limitations of Claim 1, and continues to teach the egress port (Dong 11) is located very adjacent to (as shown in Dong Figure 2) the expandable member (Dong 70).
As to Claim 5, Dong, as modified, teaches all the limitations of Claim 1, and continues to teach the expandable member (Dong 70) is a compliant balloon (Dong Paragraph 0011) inflatable to varying diameters (Dong Paragraph 0011, describes the balloon being expanded, which one of ordinary skill in the art would conclude inherently means the balloon is in a collapsed state before the balloon is expanded into an expanded state, and any state between and including the collapsed state and the expanded state would include “varying diameters”), the elongate shaft (the Dong shaft forming Dong lumens 10/20/20, as viewed in Dong Figure 2) further having an inflation lumen (Dong 20) configured for inflating (Dong Paragraph 0030) the compliant balloon (Dong 70).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nentwick (2011/0245665 – see Figure 2A) and Gemborys (2016/0175559 – see Figure 9) teach similar catheters as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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