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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1, lines 3-4 recites “the inserting end being placed into a human body through a nasal cavity of the human body”, which positively claims the human body and the nasal cavity of the human body. Examiner suggests Applicant to amend the claim to “the inserting end configured to be placed into a human body through a nasal cavity of the human body”.
Claim 1, lines 4-6 recites “the mounting end being arranged outside the nasal cavity of the human body”, which also positively claims the nasal cavity of the human body. Examiner suggests Applicant to amend the claim to “the mounting end configured to be arranged outside the nasal cavity of the human body”.
Claims 2-11 are rejected by virtue of depending on claim 1.
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) 2, 7 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.
Regarding claim 2, the phrase "normally, the first channel section is not in communication with the second channel section" renders the claim indefinite because it is unclear what “normally” means, at which state of the device.
Regarding claim 7, the phrase "the second body section is formed in a cone shape" renders the claim indefinite because it is unclear if the “cone shape” limitation of claim 7 is the same as or different from “a cone shape” limitation of claim 1. Claim 1 recites “an end part of the combining part is formed in a cone shape” while claim 7, depending on claim 1, recites “the combining part comprises … a second body section … wherein the second body section is formed in a cone shape”. So, it is unclear if the second body section of the combining part is located at the end part of the combining part, making the combining part just having one cone shape end/section; OR the second body section of the combining part is located at a different part of the combining part, making the combining part having two cone shape ends/sections. For the purpose of compact prosecution and based on Applicant’s specification and drawings, Examiner interpreted the second body section of the combining part is located at the end part, and the combining part only has one cone shape end/section.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 11 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 is identical to claim 9. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 7-8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 2014/0378907) in view of Nieman et al. (US 2014/0088567) and Heilmann et al. (US 5,694,978).
Regarding claim 1, Liu discloses
A two-section combination nasogastric tube (tube shown in figs. 1-3, see also pars. 0017-0028), comprising:
an internal tube (1, fig. 1) comprising an inserting end (one end of 1 – right end of 1) and an opposite mounting end (the opposite end of 1 – left end of 1 that is inserted into element 3), the inserting end (right end of 1) being placed into a human body through a nasal cavity of the human body (Examiner notes: the limitation “being placed into a human body through a nasal cavity of the human body” is interpreted as functional limitation. See fig. 3 and par. 0023, the right end of 1 is placed into a human body through a nasal cavity of the human body), the mounting end (left end of 1) being arranged outside the nasal cavity of the human body (Examiner notes: the limitation “being arranged outside the nasal cavity of the human body” is interpreted as functional limitation. The left end of 1 is arranged outside the nasal cavity when the right end of 1 is first inserted into the nasal cavity and placed within the nasal cavity and not yet being pushed towards the human stomach);
an external tube (2, fig. 1) comprising a feeding end (one end of 2 – bottom end of 2) and an opposite connecting end (the opposite end of 2 – top end of 2 that is coupled to element 21), the feeding end (bottom end of 2) being connected with a feeding port connector (Examiner notes: the limitation “being connected with a feeding port connector” is interpreted as functional limitation, and the limitation “a feeding port connector” is not positively recited in claim 1. See fig. 1 for the bottom end of 2 being a free end; therefore, it is capable of being connected with a feeding port connector);
a joint (21, figs. 1-2) comprising a first joint part (joint part at the bottom end of 21) and an opposite second joint part (opposite joint part at the top end of 21), the first joint part being connected with the connecting end of the external tube (see fig. 2 for the first joint part at the bottom end of 21 being connected to the top end of 2), the second joint part comprising a rotatable thread ring (211 with 212); and
a combining member (3, fig. 1) removably connected between the internal tube (1) and the joint (21), the combining member (3) comprising a base part (base of 34), a combining part (31), and a screwing part (35), the combining part (31) and the screw part (35) being disposed on opposite lateral sides of the base part (base of 34, see fig. 1), respectively, wherein an end part of the combining part (end part of 31) is formed in a shape (see figs. 1-2), the mounting end of the internal tube (left end of 1) is mounted around the end part of the combining part (see fig. 2), and the screwing part (35) is screwedly combined with the thread ring (211 with 212) of the second joint part (joint part at the top end of 21, see figs. 1-2).
Liu is silent about the first joint part of the joint being removably connected with the connecting end of the external tube.
Nieman teaches a device with multiple components (par. 0037) wherein the components are joined together by a friction fit (par. 0037).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Liu joint and Liu external tube such that they are removably connected together by a friction fit, as taught by Nieman, for the purpose of allowing the elements to be disassembled for easy exchanging/replacing when needed.
Liu is also silent about the end part of the combining part of the combining member has a cone shape.
However, Heilmann teaches an end part (2a, fig. 1) of an element (2) having a cone shape (col. 3 lines 29-31) to facilitate its insertion into an end of a tubing (see fig. 1 and col. 3 lines 29-31).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the end part of the combining part of Liu combining member to have a cone shape, as taught by Heilmann, for the purpose of facilitating its insertion into the end of Liu internal tube (col. 3 lines 29-31 of Heilmann).
Regarding claim 7, Liu in view of Nieman and Heilmann discloses the two-section combination nasogastric tube of claim 1,
Liu further discloses wherein the combining part (3, fig. 1) comprises a first body section (see annotated fig. 1 below) and a second body section (see annotated fig. 1 below); the first body section is connected between the base part (base of 34) and the second body section (see annotated fig. 1 below); the first body section comprises a ring-shaped protrusion block (see annotated fig. 2 below), and an outer diameter of the protrusion block is larger than a maximum outer diameter of the second body section (see annotated fig. 2 below for the outer diameter of the protrusion block and the maximum outer diameter of 31).
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Heilmann teaches wherein the element (2) comprises a first body section (3/4) and a second body section (2a); the first body section (3/4) is connected between the base part (7) and the second body section (2a); the second body section (2a) is formed in a cone shape (see fig. 1 and col. 3 lines 29-31); the first body section (3/4) comprises a ring-shaped protrusion block (4), and an outer diameter of the protrusion block (outer diameter of 4) is larger than a maximum outer diameter of the second body section (maximum outer diameter of 2, see fig. 1. Examiner notes: see also col. 3 lines 32-33 for 4 sized larger enough to bear upon the axial end face of tubing 1 to provide a fluid-tight seal and prevent 2 from moving further into the tubing 1).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the end part of the combining part of Liu combining member to have a cone shape, as taught by Heilmann, for the purpose of facilitating its insertion into the end of Liu internal tube (col. 3 lines 29-31 of Heilmann).
Regarding claim 8, Liu in view of Nieman and Heilmann discloses the two-section combination nasogastric tube of claim 7,
Heilmann further teaches wherein the second body section tapers from one end thereof connected with the first body section toward a direction away from the base part (see fig. 1).
Regarding claim 10, Liu in view of Nieman and Heilmann discloses the two-section combination nasogastric tube of claim 7,
Liu further discloses wherein the base part (base of 34) comprises a first face (see annotated fig. 2 below) and an opposite second face (see annotated fig. 2 below); the combining part (31) is connected with the first face (see annotated fig. 2 below), and the screwing part (35) is connected with the second face (see annotated fig. 2 below); the first face of the base part comprises two symmetrical grip parts (two grip parts on sleeve 34) protruding thereon, with the combining part arranged between the two grip parts (see annotated fig. 2 below).
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Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 2014/0378907) in view of Nieman et al. (US 2014/0088567) and Heilmann et al. (US 5,694,978) in further view of Hu et al. (US 2020/0023176).
Regarding claim 2, Liu in view of Nieman and Heilmann discloses the two-section combination nasogastric tube of claim 1,
Liu further discloses wherein the combining member (3, fig. 2) comprises a channel (33) passing through the base part (base of 34), the combining part (31), and the screwing part (35), and the channel (33) is in communication with the internal tube (1), the external tube (2), and the joint (21) (see fig. 2); the channel (33) comprises a first channel section (top section of 33 – toward internal tube 1, see fig. 2) and a second channel section (bottom section of 33 – toward external tube 2); the first channel section (top section of 33, see fig. 2) is positionally aligned with the combining part (31) and a portion of the base part (base of 34); the second channel section (bottom section of 33, see fig. 2) is positionally aligned with the screwing part (35) and a portion of the base part (base of 34).
Liu is silent about normally, the first channel section is not in communication with the second channel section.
However, Hu teaches a member (12, fig. 2D) comprising a channel (50/52) with a first channel section (50) and a second channel section (52) wherein normally, the first channel section is not in communication with the second channel section (see figs. 1C and 2D).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the channel of Liu combining member by adding a valve member within the channel, as taught by Hu, for the purpose of providing a physical barrier to control the flow of fluid between the two channel sections (par. 0038 of Hu).
Regarding claim 3, Liu in view of Nieman, Heilmann and Hu discloses the two-section combination nasogastric tube of claim 2,
Hu further teaches wherein a non-return film (44, fig. 1C and par. 0038. Examiner notes: see par. 0038 for 44 being a single-use element therefore 44 reads on “a non-return film” limitation) is disposed between the first channel section (50) and the second channel section (52); the non-return film (44) comprises a crevice (see fig. 1C), which is normally sealed (see fig. 1C);
Liu further discloses an end part of the second joint part (joint part at the top end of 21) protrudes from the thread ring (211 with 212, see figs. 1-2); when the screwing part (35) is screwed to the thread ring (211 with 212) of the joint (21).
Hu also teaches the end part of a joint part (70, fig. 2D) breaks through the crevice (44), such that the first channel section (50) is in communication with the second channel section (52, see fig. 2D).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to further modify the location of the valve member of Liu device such that the end part of the second joint part of Liu joint breaks through the valve member when Liu joint is coupled to Liu combining member, as taught by Hu, for the purpose of allowing the fluid communication when the device is in use.
Regarding claim 4, Liu in view of Nieman, Heilmann and Hu discloses the two-section combination nasogastric tube of claim 2,
Liu further discloses wherein an inner diameter of the first channel section (top section of 33) is smaller than an inner diameter of the second channel section (bottom section of 33) (Examiner notes: see fig. 2 for the bottom section of 33 comprising sleeve 34 wherein the inner diameter of the sleeve is greater than the inner diameter of 33).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 2014/0378907) in view of Nieman et al. (US 2014/0088567), Heilmann et al. (US 5,694,978) and Hu et al. (US 2020/0023176) in further view of Nguyen et al. (US 2022/0362536).
Regarding claim 5, Liu in view of Nieman, Heilmann and Hu discloses the two-section combination nasogastric tube of claim 2, as set forth above, except for wherein the combining member further comprises a closing part, which is connected to an outer periphery of the base part; the closing part is bendable to close the channel from the screwing part.
However, Nguyen teaches a member (453, fig. 4A) comprising a closing part (452), which is connected to an outer periphery of the base part (410) (see fig. 4A for 452 connected to 410 via 452A), the closing part (452) is bendable (via 452A) to close the channel (415A) from the screwing part (see fig. 4A).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Liu combining member by adding a closing part with a tether, as taught by Nguyen, for the purpose of providing a seal across the open end of the combining member when the member is not in use (par. 0055 of Nguyen).
Regarding claim 6, Liu in view of Nieman, Heilmann, Hu, and Nguyen discloses the two-section combination nasogastric tube of claim 5,
Nguyen further teaches wherein the closing part (452, fig. 4A) comprises an extension section (452A) and a plug (452); an end of the extension section is connected to the outer periphery of the base part (see fig. 4A for one end of 452A is connected to 410), and the plug (452) is disposed on a same lateral side with the screwing part (see fig. 4A) and arranged on another end of the extension section (see fig. 4A), so as to protrude thereon to tightly plug an end opening of the channel (see fig. 4A).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Liu combining member by adding a closing part with a tether, as taught by Nguyen, for the purpose of providing a seal across the open end of the combining member when the member is not in use (par. 0055 of Nguyen).
Allowable Subject Matter
Claim(s) 9 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Examiner, Art Unit 3783