DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 03/04/2026.
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 .
Status of Claims
Claim(s) 1-16 and 24-25 is/are pending in the application.
Claim(s) 1-16 and 24-25 is/are examined on the merits.
Information Disclosure Statement
The new information disclosure statements (IDS) submitted on 03/23/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the new information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments/remarks filed on 03/04/2026 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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(s) 1-16 and 24-25 is/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.
Claim 1 recites the limitations “the coil distal end being an end closest to a target tissue when the coil is introduced into the target tissue and the coil proximal end being an end farther away from the target tissue than the coil distal end when the coil is introduced into the target tissue” which is indefinite. According to ¶0027 and Fig. 1, the coil proximal end being an end closest to a target tissue when the coil is introduced into the target tissue (“proximal end of the coil 110 preferably includes a plug 115 to seal the proximal end of the coil 110 to prevent the introduction into the coil 110 of fluids or other debris that might clog the lumen of the coil 110”). Furthermore, Applicant identified the proximal end of coil is the end with the plug 115 and the distal end of the coil is the opposite end in Applicant’s arguments/remarks filed on 03/04/2026. Thus, the proximal end of coil is an end closest to the target tissue. The limitation has been examined below as if it read -- the coil [[distal]] proximal end being an end closest to a target tissue when the coil is introduced into the target tissue and the coil [[proximal]] distal end being an end farther away from the target tissue than the coil [[distal]] proximal end when the coil is introduced into the target tissue --.
Claim(s) 2-16 and 24-25 is/are rejected as being dependent from claim 1 and therefor including all the limitation thereof.
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 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.
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) 1, 12, and 24-25 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Hirszowicz (US PGPUB 20100262124).
Regarding claim 1, Hirszowicz discloses a device configured for use in negative pressure wound therapy (a balloon catheter: ¶0016, 0073, and Fig. 3), comprising:
a tube (a conduit or catheter shaft 10: Figs. 1 and 3) having a tube proximal end (see annotated Fig. 3 below) and a tube distal end (see annotated Fig. 3 below), the tube distal end being an end closest to a target tissue when the tube is introduced into the target tissue and the tube proximal end being an end farther away from the target tissue than the tube distal end when the tube is introduced into the target tissue (see annotated Fig. 3 below); and
a coil (a balloon 12: ¶0072, 0075, and Fig. 3) having a plurality of windings (a spiral channel 16: ¶0075 and Fig. 3) extending from a coil proximal end to a coil distal end (see annotated Fig. 3 below), the coil proximal end being an end closest to a target tissue when the coil is introduced into the target tissue and the coil distal end being an end farther away from the target tissue than the coil proximal end when the coil is introduced into the target tissue, wherein the coil distal end is coupled to the tube proximal end (¶0071 and see annotated Fig. 3 below) in a manner configured to enable application of a negative pressure from within the coil through the coil to tissue surrounding the coil (¶0073), and wherein the coil comprises a space between adjacent ones of the plurality of windings (¶0072 and Fig. 3), the space having a predetermined dimension (¶0077).
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Regarding claim 12, Hirszowicz further discloses a cross-section of the coil is one of round, square, or triangular (round cross-section: Figs. 3 and 5).
Regarding claim 24, Hirszowicz further discloses the coil distal end is coupled to the tube proximal end configured to enable application of a negative pressure to the tissue surrounding the coil (¶0073).
In addition, since the taught device and the claimed device are patentably indistinct in term of structures, the taught device is considered/expected to be capable of enabling application of a negative pressure to draw together adjacent tissues of an incision for wound therapy. See MPEP §§ 2112.01 (I) and 2114 (I)-(II).
Regarding claim 25, Hirszowicz further discloses the coil distal end is coupled to the tube proximal end configured to enable application of a negative pressure to the tissue surrounding the coil (¶0073).
In addition, since the taught device and the claimed device are patentably indistinct in term of structures, the taught device is considered/expected to be capable of enabling application of a negative pressure to draw at least a portion of the tissue gainst or between the windings of the coil. See MPEP §§ 2112.01 (I) and 2114 (I)-(II).
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 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.
Claim(s) 2 and 8-9 is/are rejected under 35 U.S.C 103 as being unpatentable over Hirszowicz (US PGPUB 20100262124).
Regarding claim 2, Hirszowicz further discloses the coil is a helical coil (¶0077).
Hirszowicz discloses the claimed invention except for detachably coupling to the tube so that the coil may be removed from the tube. It is a law of physics that pieces of an apparatus are necessarily capable of being detached from one another. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to make/have the coil/balloon detachably couple to the tube/cathter, since it has been held that constructing formerly integral structure in various elements involves only routine skill in art.
Regarding claim 8, Hirszowicz does not disclose the predetermined dimension of the space is between 2µm-80µm.
However, Hirszowicz further discloses the balloon has a length in the range of 15 mm to 50 mm and a wall thickness in the range of 100 micron to 400 micron (¶0103) and the preceding dimensions and all other dimensions are exemplary values only and should not be construed as limiting the size of the presently-disclosed device (¶0103).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Hirszowicz by selecting the predetermined dimension of the space within the claimed range, in order to provide the predetermined dimension of the space according to the application for which the device is intended, as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Regarding claim 9, Hirszowicz does not disclose the predetermined dimension of the space is between 40µm-60µm.
However, Hirszowicz further discloses the balloon has a length in the range of 15 mm to 50 mm and a wall thickness in the range of 100 micron to 400 micron (¶0103) and the preceding dimensions and all other dimensions are exemplary values only and should not be construed as limiting the size of the presently-disclosed device (¶0103).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Hirszowicz by selecting the predetermined dimension of the space within the claimed range, in order to provide the predetermined dimension of the space according to the application for which the device is intended, as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
Claim(s) 4 is/are rejected under 35 U.S.C 103 as being unpatentable over Hirszowicz (US PGPUB 20100262124) in view of Zarbatany (US PGPUB 20070005079).
Regarding claim 4, Hirszowicz does not disclose a suture needle coupled to the tube distal end.
In an analogous art for being directed to solve the same problem, suturing the tissue via a suture needle, Zarbatany discloses a catheter comprising a distal end and a proximal end (Fig.2). Zarbatany further discloses the catheter comprising a suture needle (¶0014 and 0016) in order to suture tissue (¶0016).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Hirszowicz in view of Zarbatany by incorporating a suture needle coupled to the tube distal end in order to suture tissue, as suggested in ¶0016 of Zarbatany.
Claim(s) 5-6 is/are rejected under 35 U.S.C 103 as being unpatentable over Hirszowicz (US PGPUB 20100262124) in view of Cushner (US PGPUB 20070270714).
Regarding claims 5-6, Hirszowicz further discloses the tube proximal end is configured to fit into the coil distal end (¶0025, 0032, and 0040), but does not disclose the tube proximal end is press fit into the coil distal end and a connection between the coil and the tube is configured to permit, after placement of the device at a desired location within tissue, the tube to be pulled free from the coil when a force of at least a predefined release amount is applied between the coil and the tube.
In an analogous art for being directed to solve the same problem, providing connection means between a device and tube, Cushner discloses a system and method for retaining a tissue specimen obtained via a collection tube (Abstract). Cushner further discloses/suggests a connection between a collection tube A or a suction tube B and a collection device 100 defining a bore extending therethrough in coaxial relation with the suction tube and the collection tube is an interference fit (press fit: ¶0031-0032 and Fig. 1) for the benefit of providing a connection means such that a collection device is configured to be removably engaged with the collection/suction tube (¶0007 and ¶0031).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Hirszowicz as disclosed by Cushner by making/having the tube proximal end press fit into the coil distal end, in order to providing a connection means between the tube and the coil such that the tube is configured to be removably engaged with the coil, as suggested in ¶0007 and 0031 of Cushner. Thus, the connection between the coil and the tube of Hirszowicz in view of Cushner is capable of permitting, after placement of the device at a desired location within tissue, the tube to be pulled free from the coil when a force of at least a predefined release amount is applied between the coil and the tube.
Claim(s) 7 is/are rejected under 35 U.S.C 103 as being unpatentable over Hirszowicz (US PGPUB 20100262124) in view of Calicchio (US PAT 2593980).
Regarding claim 7, Hirszowicz does not disclose the coil is formed of a bioabsorbable material.
In an analogous art for being directed to solve the same problem, providing a medical device that is made of bioabsorbable material, Calicchio discloses a drainage tube of bioabsorbable material such as catgut (Col. 1, lines 30-35) for the benefits of providing materials that is absorbable by human system and eliminating the need for additional surgeries to remove the tube from the patient’s system (Col. 2, lines 5-15 and lines 30-35). From these teachings, a person having ordinary skill in the art would have recognized/deduced that selecting bioabsorbable material as the material of the coil yields the predictable result of providing the coil that is absorbable by human system and eliminate the need for additional surgeries to remove the tube from the patient’s system.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the coil/balloon of Hirszowicz in view of Calicchio by selecting bioabsorbable material to be the material in order to provide the coil that is absorbable by human system and eliminate the need for additional surgeries to remove the tube from the patient’s system, as suggested in Col. 2, lines 5-15 and lines 30-35 of Calicchio and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07). Further, one would have been motivated to select the material of the coil to be bioabsorbable material for the purpose of minimizing concerns about adverse effects.
Claim(s) 10-11 is/are rejected under 35 U.S.C 103 as being unpatentable over Hirszowicz (US PGPUB 20100262124) in view of Chen (US PGPUB 20180043135).
Regarding claims 10-11, Hirszowicz does not disclose the coil includes an antimicrobial and the antimicrobial is within the coil or formed as a coating on a surface of the coil.
In an analogous art for being directed to solve the same problem, having anti-microbial coating on a surface of a medical tube/catheter, Chen discloses a catheterization device 102 comprising an umbrella-like expandable catheter (¶0009). Chen further discloses/suggests the catheter/tube is coated with an anti-microbial material coating (¶0011) for the benefit of assisting patient in resisting infection (¶0011).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the device of Hirszowicz as disclosed by Chen by applying antimicrobial coating on the surface of the coil, in order to assist patient in resisting infection, as suggested in ¶0011 of Chen.
Claim(s) 13 is/are rejected under 35 U.S.C 103 as being unpatentable over Hirszowicz (US PGPUB 20100262124) in view of Zaretzka (US PGPUB 20120209273).
Regarding claim 13, Hirszowicz does not disclose the coil has a triangular cross-section, a vertex angle and height of the coil are selected to achieve a desired distance between adjacent turns of the coil at radially outermost points of the coil.
In an analogous art for being directed to solve the same problem, having various cross-section shapes for helical member of a device, Zaretzka discloses a tissue transport assembly 4034 comprising a rotatable drive member 4030, a helical member 4032 mounted on at least a portion of the rotatable drive member 4030, and a tubular cap 4036 attached at a distal portion of the drive member 4030 (¶0158 and Fig. 41A). Zaretzka further discloses a cross-section of helical member 4032 has any shape such as triangular or square (¶0158) for the benefit of assisting in tissue transport (¶0158).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Hirszowicz as disclosed by Zaretzka by selecting a triangular cross-section for the coil, in order to assist in tissue transport, as suggested in ¶0158 of Zaretzka and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)). Since the coil of Hirszowicz in view of Zaretzka has a triangular cross-section, a vertex angle and height of the coil are expected to be capable of achieving a desired distance between adjacent turns of the coil at radially outermost points of the coil.
Allowable Subject Matter
Claim(s) 3 and 14-16 is/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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, Hirszowicz fails to disclose the tube proximal end is sealed to prevent materials from being introduced into the coil. Since the device of Hirszowicz is configured to have open spinal channel to prevent occlusion of the blood vessel when the balloon is fully inflated and the spiral channel of Hirszowicz is configured to be used for the capture and removal of particulate matter (e.g. thrombotic material) from the blood vessel (¶0075), there is no reason to seal the tube proximal end to prevent materials from being introduced into the coil. Adding a seal at the tube proximal end would destroy the intended operation of the device of Hirszowicz.
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
Regarding claim 14, Hirszowicz fails to disclose a first hollow tube including a plurality of first openings open from a first tube lumen within the first hollow tube to the coil lumen.
Rosenberg (US PAT 7037288) discloses a medical device 10 comprising a catheter 12 having a proximal end 18 and a distal end 22 (Abstract and Fig. 2B). Rosenberg further discloses the distal end 22 of the catheter 12 comprising a coil having a coil proximal end and a coil distal end 24 (Col. 3, lines 52-65; and Fig. 2B) and the coil comprising at least one fluid entry port/pore 42 (Col. 3, line 60 – Col. 4, line 2; and Fig. 4). Since the device of Hirszowicz is configured to have open spinal channel to prevent occlusion of the blood vessel when the balloon is fully inflated, there is no reason to incorporate openings/pores within the coil/balloon as this modification increases the complexity of the system in the prior art in terms of structure, function, and design (See MPEP §2143.01 (IV)).
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
Therefore, claim 14 and its dependent claims 15-16 are deemed novel and non-obvious over the prior art of record.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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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.
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/NHU Q. TRAN/ Examiner, Art Unit 3781
/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
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