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 .
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.
Claims 1-13, 29 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 limitation "wherein the reinforcement material section comprises a first hardness in the first region and a second hardness in the second region" in lines 10-11. It is unclear if it means "wherein the reinforcement material section comprises a first material with a first hardness in the first region and a second material with a second hardness in the second region” ( see Fig. 9b, 130 end 120 joint with 134. Also, the term “ hardness” is a properties of a material not structural design) or it means "wherein the reinforcement material section comprises a first hard portion in the first region and a second hard portion in the second region" ( the rigidity level of the material section is changed due to structural design such as dimensional change, embedded other metrical, density of winding etc. see ¶0128 and claim 2). For the purpose of examination, the examiner will interpret the limitation such as "wherein the reinforcement material section comprises a first material with a first hardness in the first region and a second material with a second hardness in the second region”.
All remaining claims are rejected as they depend from rejected independent claim 1.
Claim Rejections - 35 USC § 102
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) 14-15, 17-18, 21-24, 27-28 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Stern (US. 20170182290A1).
Re Claim 14, Stern discloses a medical tubing (Fig. 1-6b) comprising: a tubular body (12, Fig. 1) having a first region (17c in Fig. 1, lower portion of 30 in Fig. 3a under the A-A line) adjacent to a second region (17b in Fig. 1, upper portion of 30 in Fig. 3a above the A-A line) each extending along an axial length of the tubular body (Fig. 1); and a plurality of material sections (24 and 18a, 18b, 20a, 20b, ¶0161) extending spirally along the axial length forming a wall of the first region and the second region of the tubular body (24 and 18a, 18b, 20a, 20b, forming a wall 24, 28, ¶0161); wherein in the first region, each of the plurality of material sections in the first region comprises a first polymer (carbon-fiber reinforced polymers ¶0161 and wherein 18s and 20s can be made from more polymers including carbon-fiber reinforced polymer) comprises a first hardness (hardness of carbon-fiber reinforced polymers, ¶0161, ¶0170); wherein at the second region at least one of the plurality of material sections comprises one or more polymers (18a) having a second hardness less than the first hardness (nylon ¶0161).
Re Claim 15, Stern discloses wherein in the second region at least one of the plurality of material sections comprises the first polymer (¶0161, Fig. 3a).
Re Claim 17, Stern discloses wherein in the second region at least one of the plurality of material sections comprises the first polymer having a uniform width along at least a portion of the second region (20b, Fig. 3a).
Re Claim 18, Stern discloses further comprising an inner liner that is interior to the tubular body (22, Fig. 2, Fig. 3b).
Re Claim 21, Stern discloses wherein the plurality of material sections extends in in a right-hand wind direction in the first region (¶0156).
Re Claim 22, Stern discloses wherein the plurality of material sections extends in in a left-hand wind direction in the first region ( if viewed from proximal direction, ¶0156).
Re Claim 23, Stern discloses wherein at least one of the plurality of material sections comprises a non-fusable material (Fig. 3a).
Re Claim 24, Stern discloses further comprising a soft distal tip section (12b,¶0164, distal portion is more flexible than the other portion, ¶00192).
Re Claim 27, Stern discloses wherein, in at least the first region, the plurality of material sections includes at least one identifiable material section that is visually distinguishable from a remainder of the plurality of material sections, where the at least one identifiable material section comprises the first hardness (stainless steel can be visualized under the imaging technology, ¶0217).
Re Claim 28, Stern discloses wherein the wall is an exterior wall of both the first region and second region of the tubular body (24, 28 are the exterior wall).
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.
Claim(s) 1-11, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern in view of Okajima (US, 554139) and further in view of Palmer et al. (US, 20180289925A1) (“Palmer”).
Re Claim 1, Stern discloses a medical tubing ( Fig, 1-6b) comprising: a tubular body having an axis extending lengthwise (12, Fig. 1, 30 in Fig. 3a-b, ¶0170), the tubular body having a first region (17b) and a second region (17c), wherein both the first region and the second region extend along the axis (Fig. 1) and both the first region and the second region have a wall (24. 28) formed from a plurality of material sections (18a, 18b, 20a, 20b, 24) that extend spirally along the axis (28 and 24, Fig. 2, Fig, 3a, ¶0170); the plurality of material sections including a reinforcement material section 20b, ¶0170) located between a first plurality of an adjacent material section in the first region and a second plurality of adjacent material section in the second region (Fig. 1, Fig. 3a) wherein the reinforcement material section extends in a continuous spiral over the first region and over the second region (20b, ¶0170), and it further disclose that materials section can be from different material (¶0170, such as 20b has hardness more than the hardness of others) and the tubular body has increasing hardness along the body (¶0167), but it fails to disclose that the reinforcement material section comprises a first hardness in the first region and a second hardness in the second region, where the first hardness is different than the second hardness and wherein the first plurality of adjacent material sections is different from the second plurality of adjacent material sections.
However, Okajima discloses a catheter (Fig, 1-5) that has a tubular body has a first region ( region that has 71) and a second region ( region that has 72, 73) and wherein the reinforcement material section (71, 73, 72) comprises a first hardness in the first region (Col. 20, lines 1-30) and a second hardness in the second region (72), where the first hardness is different than the second hardness (Col. 20, lines 1-30).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first plurality material section and the second plurality material section of Stern so that the reinforcement material section comprises a first hardness in the first region and a second hardness in the second region, where the first hardness is different than the second hardness as taught by Okajima for the purpose of capability of changing the stiffness (Okajima, Col. 20, lines 1-30).
However, Palmer discloses a catheter (Fig, 14-18) a tubular body with a first plurality of adjacent material (right to 160, 154, 350, 150 and 130) which is different that a second plurality of adjacent material (left to 160, 152, 350, 150 and 130, at least 154 and 152 are different, ¶0208) and wherein Palmer uses different materials in two different region to change the hardness of the tubular body alongside of the catheter.
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first plurality material section and the second plurality material section of Stern so that the first plurality of adjacent material sections is different from the second plurality of adjacent material sections as taught by Palmer for the purpose of capability of changing the stiffness (Palmer, ¶0198).
Re Claim 2, Stern fails to disclose wherein in the first region the reinforcement material section comprises a first structural dimension and in the second region the reinforcement material section comprises a second structural dimension different than the first structural dimension.
However, Okajima discloses wherein in the first region the reinforcement material section comprises a first structural dimension ( thickness of 71 above 73) and in the second region the reinforcement material section comprises a second structural dimension different than the first structural dimension ( thickness of 71 at 73).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the reinforcement material section of Stern so that in the first region the reinforcement material section comprises a first structural dimension and in the second region the reinforcement material section comprises a second structural dimension different than the first structural dimension as taught by Okajima for the purpose of capability of changing the stiffness (Okajima, Col. 20, lines 1-30).
Re Claim 3, the modified Stern discloses wherein the first hardness is greater than a respective hardness of each of the first plurality of adjacent material sections (carbon polymer is harder than other polymers, ¶0161).
Re Claim 4, Stern discloses wherein the second hardness is greater than a respective hardness of each of the second plurality of adjacent material sections (carbon polymer is harder than other polymers, ¶0161).
Re Claim 5, Stern discloses further comprising an inner liner that is interior to the tubular body (22, ¶0152).
Re Claim 6, Stern discloses further comprising a reinforcement structure is exterior to the inner liner (Fig. 3b).
Re Claim 7, Stern discloses wherein the reinforcement structure is embedded within the wall (28, Fig. 3b).
Re Claim 8, Stern discloses wherein the plurality of material sections extends in in a right-hand wind direction in the first region (¶0156).
Re Claim 9, Stern discloses wherein the plurality of material sections extends in in a left-hand wind direction in the first region (¶0156, if the point of view from proximal end).
Re Claim 10, Stern discloses wherein at least one of the plurality of material sections comprises a non-fusable material (¶0170).
Re Claim 11, Stern discloses further comprising a soft distal tip section (12b,¶0164, distal portion is more flexible than the other portion, ¶00192).
Re Claim 29, Stern discloses wherein the wall is an exterior wall of both the first region and second region of the tubular body (24, 28 are the exterior wall).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern in view of Okajima and Palmer and further in view of Takagi et al. (US. 20100030165A1) (“Takagi”).
Re Claim 12, Stern fails to disclose wherein the soft distal tip section comprises a single material.
However, Takagi disclose a catheter (Fig.4) and wherein the soft distal tip section comprises a single material (4, Fig. 1, ¶0067-¶0068).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the reinforcement material section of Stern so that the soft distal tip section comprises a single material as taught by Takagi for the purpose of having tubular member with a desired tip with flexibility from an art recognized material (Takagi, ¶0067-¶0068).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern in view of Okajima and Palmer and further in view of Wada (US. 20190134348A1).
Re Claim 13, Stern discloses wherein the tubular body comprises a proximal region located (17a) proximally to both the first region and the second region (Fig. 1), but it fails to disclose that the proximal region comprising a single material.
However, Wada disclose a catheter (Fig.1-3) and wherein the tubular body comprises a proximal region (14c, Fig. 3 at line -e-) located proximally to both the first region (region at line -d- ) and the second region (region at line -c-) , the proximal region comprising a single material (Fig. 3, ¶0037, ¶0051).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal region of the tubular body of Stern so that the proximal region comprising a single material as taught by Wada for the purpose of having tubular member with a hardest material as an art recognized material (Wada, ¶00637, ¶0051).
Claim(s) 16, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern in view of Plamer et al. (US. 20180289925A1) (“Plamer”).
Re Claim 16, Stern fails to disclose wherein the first polymer is terminated before or in the second region.
However, Plamer disclose a catheter (Fig.17) and wherein the first material (152, ¶0181, Fig. 17) is terminated before or in the second region ( first region left until 160 and second region right start at 160) and wherein changing the material section is for controlling the catheter flexibility/hardness (¶0181).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the first material of Stern so that the first polymer is terminated before or in the second region as taught by Plamer for the purpose of controlling the saltiness of the tubular member (Plamer, ¶0189).
Re Claim 19, Stern fails to disclose further comprising a reinforcement structure exterior to the inner liner.
However, Plamer disclose a catheter (Fig.17) and wherein a reinforcement structure (120, ¶0180) exterior to the inner liner (110, ¶0180).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify tubular body of Stern to include a reinforcement structure so that the tubular body further comprising a reinforcement structure exterior to the inner liner as taught by Plamer for the purpose of controlling the saltiness of the tubular member (Plamer, ¶0180).
Re Claim 20, Stern fails to disclose wherein the reinforcement structure is embedded within the wall.
However, Plamer disclose a catheter (Fig.17) and wherein a reinforcement structure (120, ¶0180) is embedded within the wall (130, ¶0180).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify tubular body of Stern to include a reinforcement structure so that the reinforcement structure is embedded within the wall as taught by Plamer for the purpose of controlling the saltiness of the tubular member (Plamer, ¶0180).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern in view of Takagi et al. (US. 20100030165A1) (“Takagi”).
Re Claim 25, Stern fails to disclose wherein the soft distal tip section comprises a single material.
However, Takagi disclose a catheter (Fig.4) and wherein the soft distal tip section comprises a single material (4, Fig. 1, ¶0067-¶0068).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the reinforcement material section of Stern so that the soft distal tip section comprises a single material as taught by Takagi for the purpose of having tubular member with a desired tip with flexibility from an art recognized material (Takagi, ¶0067-¶0068).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern in view of Wada (US. 20190134348A1).
Re Claim 26, Stern discloses wherein the tubular body comprises a proximal region located (17a) proximally to both the first region and the second region (Fig. 1), but it fails to disclose that the proximal region comprising a single material.
However, Wada disclose a catheter (Fig.1-3) and wherein the tubular body comprises a proximal region (14c, Fig. 3 at line -e-) located proximally to both the first region (region at line -d- )and the second region (region at line -c-) , the proximal region comprising a single material (Fig. 3, ¶0037, ¶0051).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal region of the tubular body of Stern so that the proximal region comprising a single material as taught by Wada for the purpose of having tubular member with a hardest material as an art recognized material (Wada, ¶00637, ¶0051).
Response to Arguments
Applicant's arguments in the appeal filed on 7/9/2026 with respect to claims 14 have been fully considered but they are persuasive. The examiner rearrange the limitation to clear up the rejection and not using steel or nitinol. The applicant argues that Stern fails to discloses “each of the material section from the plurality of material section I the first region comprises the first polymer having the firs hardness. This is found not persuasive as Stern discloses in ¶0161 that materials of 18s, 20s can be made from one or more polymer such as carbon fiber polymer which has a first hardness.
The argument in page 4 with regard to claim 29 have been fully considered but they are not persuasive. The applicant argues that 24 is the exterior wall. This is found not persuasive as an exterior wall can be a sandwich wall or composite wall. Note, in order to overcome this rejection , the applicant is advised to further define the exterior wall such as the exterior wall consisted of an outermost layer or outer layer ..etc.
Applicant’s arguments in page 5-6 with respect to the rejection(s) of claim(s) 1 and a first hardness and the second hardness have been fully considered and are persuasive. However, upon further consideration, a new ground(s) of rejection is made over Stern in view of Okajima and Palmer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
