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 .
Claims 1-15 are being examined in this Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the containing portions, upper pressing portion, and lower pressing portion must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0065], connecting seats is given reference numeral 31. Previously, reference numeral 31 is used to refer to “pressing portions”.
Appropriate correction is required.
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.
Claims 1-15 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 recites the limitation “through which the fitting component is fixed to philtrum below nares”. The requirement of this limitation is the fitting component being fixed to the philtrum below nares of a human organism. Examiner recommends to amend the limitation to say “the fitting component is configured to be fixed to philtrum below nares”.
Claim 8 recites the limitation “wherein bending portions are arranged in the strip plates and extend to auricle”. The requirement of this limitation is the bending portions extend to the auricle of a human organism. Examiner recommends to amend the limitation to say “wherein the bending portions are arranged in the strip plates and are configured to extend to an auricle of a user”
Claim 14 recites the limitation “wherein the containing portions are obliquely arranged along a direction of nares”. The requirement of this limitation is the containing portions are arranged along a direction of the nares of a human organism. Examiner recommends to amend the limitation to say “wherein the containing portions are configured to be obliquely arranged along a direction of the nares”.
All remaining claims are rejected by virtue of being dependent on a rejected claim.
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 1-15 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 “the other end” in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “at least two pressing portions” in lines 4-5, and the claim also recites “two pressing portions” in line 7 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 2 recites the limitation “the pressing portions” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation “the other pressing portion” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the two pressing portions” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
The term “link” in claim 3 is a relative term which renders the claim indefinite. The term “link” 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.
Claim 7 recites the limitation “the strip plates are connected with bandages”. It is unclear how the strip plates are connected. Examiner interprets that the strip plates are connected with bandages that are configured to connect by wrapping around a patient’s head.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation "at least one limiting member" in line 2, and the claim also recites "the limiting member" in line 3 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 11 recites the limitation “wherein at least two limiting members are provided, and openings of the limiting members are located on both sides of the strip plates in respective”. It is unclear if the at least two limiting portions are located on a single strip plate, or if the at least two limiting members are located on different strip plates. Examiner interprets this limitation to mean that at least two limiting members are located on different strip plates.
Claim 11 recites the limitation “the limiting members” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the plugging holes” in lines 2, 4, and 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “wherein a plurality of connecting seats are arranged on the fitting component and provided with the plugging holes, both ends of the pressing portions connected with the fitting component are provided with second protrusion portions after passing through the plugging holes, and one end of each of the strip plates that is connected with the fitting component is provided with a first protrusion portion after passing through the plugging holes”. It is unclear how both the protrusions of the fitting component and the protrusions of the strip plates are meant to pass through the plugging holes, whether the protrusions are passing through the same plugging hole, or separate plugging holes. Examiner interprets the first and second protrusions are passing through different plugging holes.
All remaining claims are rejected by virtue of their dependance on a rejected claim.
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, 2, 4-6, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman (US 6361523 B1) in view of Shen (CN 216855264 U).
Regarding Claim 1, Bierman discloses a fixing device for double-tube intubation (Fig. 2, Col. 5 Lines 49-55), comprising a fitting component (12) and a fixing frame (20) arranged on the fitting component (Figs. 1-2), the fixing frame comprises at least two pressing portions (top portion of 24), one end of each of the pressing portions is connected mutually (Fig. 4) while the other end is in mutual opening and closing connection (Figs. 4-5b), and containing portions for placing an intubation pipeline are arranged between the two pressing portions (region where 114 and 116 sit in Fig. 6).
Bierman does not expressly disclose wherein both ends of the fitting component are connected with a connecting portion, through which the fitting component is fixed to philtrum below nares.
Shen teaches wherein both ends of the fitting component (11) are connected with a connecting portion (12, Fig. 1), through which the fitting component is fixed to philtrum below nares (“pipeline fixing piece is stably bound under the nasal patient through the bandage, for stable limit of nasal feeding tube, avoiding falling, ensuring the normal nasal feeding” – Page 2 Paragraph 8).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by Bierman wherein both ends of the fitting component are connected with a connecting portion, through which the fitting component is fixed to philtrum below nares as taught by Shen so that mounting and dismounting of the fixing device is convenient and fast (Shen, Page 2 Paragraph 9).
Regarding Claim 2, modified Bierman in view of Shen discloses the fixing device for double-tube intubation according to claim 1, wherein at opening and closing connecting ends of the pressing portions, one end of one of the pressing portions is equipped with latches (Bierman, 90), and one end of the other pressing portion is equipped with a fixture block (Bierman, 88, Figs 8-10) that fits with the latches and is in opening and closing connection (Bierman, Col. 14 Lines 42-48).
Regarding Claim 4, modified Bierman in view of Shen discloses the fixing device for double-tube intubation according to claim 2, wherein a plurality of latches are provided (Bierman, “The latch mechanism 86 comprises at least one moveable keeper 88 and at least one latch 90.” – Col. 14 Lines 44-45, Examiner interprets at least one latch to be a plurality of latches).
Regarding Claim 5, modified Bierman in view of Shen discloses the fixing device for double-tube intubation according to claim 1, wherein one end of each of the pressing portions that is away from the opening and closing connection end is hinged or elastically connected (Bierman, Col. 15 Lines 22-25, Fig. 4).
Regarding Claim 6, modified Bierman in view of Shen discloses the fixing device for double-tube intubation according to claim 1, wherein a pressing column (Bierman, 80 connected to 24 in Fig. 4) is arranged inside one pressing portion (Bierman, 24) and at least two groups of limiting columns (Bierman, 80 connected to 22 in Fig. 4) are arranged inside the other pressing portion (Bierman, 24), both the pressing column and the limiting columns are protruded from the containing portion (Bierman, 80 protruding from channel 60), and the pressing column is located between the two groups of limiting columns (Bierman, 80 connected to 24 appears to be located in between barbs 80 connected to 22 in Fig. 5b).
Regarding Claim 14, modified Bierman in view of Shen discloses the fixing device for double-tube intubation according to claim 1, wherein the containing portions (Shen, 2) are obliquely arranged along a direction of nares (Shen, “The pipe fixing piece 2 is fixed on the lower patient of the nasal cavity through the bandage 1 set patient the head, so as to effectively fix the nasal feeding pipe extending into the nasal cavity.” – Page 3 Paragraph 2).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by Bierman wherein the containing portions are obliquely arranged along a direction of nares as taught by Shen so that the tubing is able to extend into the nasal cavity of a user (Shen, Page 3 Paragraph 2).
Regarding Claim 15, modified Bierman in view of Shen discloses the fixing device for double-tube intubation according to claim 1, wherein the fitting component is made of silica gel (Shen, “As shown in FIG. 4, the inner side of the bandage 1 is provided with a skid-proof cushion block 16, skid-proof cushion block 16 is made of medical silica gel. skid-proof cushion block 16 is silica gel gasket, through strong glue is adhered on the inner side of the fixing block 11, and contact, to ensure the stability of the bandage 1.” – Page 3 Paragraph 8).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by Bierman wherein the fitting component is made of silica gel as taught by Shen to improve comfort (Shen, Page 3 Paragraph 1).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Shen, further in view of Wright et al. (Pub. No. US 20100114034 A1, herein Wright).
Regarding Claim 3, modified Bierman in view of Shen discloses the fixing device for double-tube intubation according to claim 1, wherein the two pressing portions are arranged in a form of upper (Bierman, 24) and lower structures (Bierman, 22), and divided into an upper pressing portion (Bierman, bottom side of 24) and a lower pressing portion (Bierman, upper side of 22);
a pressing section of the upper pressing portion is wavy (Bierman, bottom side of 24 demonstrating wavy shape in Fig. 4) and formed with two arc-shaped upper pressing slots with downward openings (Bierman, Fig. 4); and the lower pressing portion is provided with a base (Bierman, bottom of 22), correspondingly to each upper pressing slot of an upper pressing section (Bierman, Fig. 5a), the base is provided with a corresponding arc-shaped lower pressing slot (Bierman, Fig. 5b), and the upper pressing slots and the lower pressing slots form the containing portions for placing the intubation pipeline (Bierman, Figs. 5b-6);
wherein a link (Bierman, 74) that is lower than a lower pressing notch portion is arranged between the two lower pressing slots of the lower pressing portion (Bierman, Fig. 4).
Modified Bierman in view of Shen does not expressly disclose both ends of the base are provided with protrusion portions raised upwards, a plurality of connecting seats are arranged on the fitting component and provided with plugging holes, both ends of the base connected with the fitting components is clamped and fixed through the protrusion portions after passing through the plugging holes of the connecting seats, another connecting seat is also provided between the above two connecting seats, and the lower pressing portion passes through the plugging hole of the another connecting seat from one end, such that the link is clamped with the another connecting seat, thus fixing the pressing portions from the middle of the base.
Wright teaches both ends of the base are provided with protrusion portions raised upwards (57, Fig. 1), a plurality of connecting seats (30) are arranged on the fitting component and provided with plugging holes (Fig. 1), both ends of the base connected with the fitting components is clamped and fixed through the protrusion portions after passing through the plugging holes of the connecting seats (Fig. 2B), another connecting seat (24) is also provided between the above two connecting seats (Fig. 1), and the lower pressing portion passes through the plugging hole of the another connecting seat from one end (Fig. 2B), such that the link (70) is clamped with the another connecting seat, thus fixing the pressing portions from the middle of the base (Fig. 2A).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by modified Bierman in view of Shen wherein both ends of the base are provided with protrusion portions raised upwards, a plurality of connecting seats are arranged on the fitting component and provided with plugging holes, both ends of the base connected with the fitting components is clamped and fixed through the protrusion portions after passing through the plugging holes of the connecting seats, another connecting seat is also provided between the above two connecting seats, and the lower pressing portion passes through the plugging hole of the another connecting seat from one end, such that the link is clamped with the another connecting seat, thus fixing the pressing portions from the middle of the base as taught by Wright to secure the fixation device by fastening the pressing portions together (Wright, Paragraph [0052]).
Claim(s) 7, 9, 10, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Shen further in view of Peterson et al. (US 4480639 A, herein Peterson).
Regarding Claim 7, modified Bierman in view of Shen discloses the fixing device for double-tube intubation according to claim 1, wherein the connecting portion comprises strip plates connected with the fitting component (Shen, 12 connected to 11 via 14 in Fig. 2).
Modified Bierman in view of Shen does not expressly disclose wherein the strip plates are connected with bandages.
Peterson teaches the strip plates (12) are connected with bandages (fastening band 20 connecting both ends of strap 12 in Figs 1-2).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by modified Bierman in view of Shen wherein the strip plates are connected with bandages as taught by Peterson in order to hold the fixation device in position while in use (Peterson, Col. 2 Lines 42-45).
Regarding Claim 9, modified Bierman in view of Shen and Peterson discloses the fixing device for double-tube intubation according to claim 7, wherein the strip plates are connected with at least one limiting member (Peterson, 14), and a channel (Peterson, 30), through which the intubation pipeline passes, is arranged in the limiting member (Peterson, Fig. 2).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by modified Bierman in view of Shen wherein the strip plates are connected with at least one limiting member, and a channel, through which the intubation pipeline passes, is arranged in the limiting member as taught by Peterson in order to hold the tubing in position (Peterson, Col. 2 Lines 50-57).
Regarding Claim 10, modified Bierman in view of Shen and Peterson discloses the fixing device for double-tube intubation according to claim 9, wherein one side of the limiting member is provided with an opening (Peterson, opening formed at 26 and 28 in Fig. 1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by modified Bierman in view of Shen and Peterson wherein one side of the limiting member is provided with an opening as taught by Peterson so that the limiting member may have a guide in which to insert the tubing (Peterson, Col. 2 Line 68 through Col. 3 Line 2).
Regarding Claim 12, modified Bierman in view of Shen and Peterson discloses the fixing device for double-tube intubation according to claim 7, wherein one pressing portion (Bierman, 22) is detachably connected with the fitting component (Bierman, Col. 8 Lines 40-43, retainer 20 disconnected with anchor pad 20 before being connected with an adhesive or other bonding material), and the strip plates are detachably connected with the fitting component (Shen, 12 being separable from 11 via 14).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by Modified Bierman in view of Peterson wherein the strip plates are detachably connected with the fitting component as taught by Shen to allow for a user to change the length of the strip plates, increasing comfort for a patient (Shen, Page 3 Paragraph 7).
Regarding Claim 13, modified Bierman in view of Shen and Peterson discloses the fixing device for double-tube intubation according to claim 12, wherein both ends of the pressing portions connected with the fitting component are provided with second protrusion portions (Shen, hooked portion of 141) after passing through the plugging holes (Shen, inside of 142, Fig. 1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by modified Bierman in view of Peterson wherein both ends of the pressing portions connected with the fitting component are provided with second protrusion portions after passing through the plugging holes as taught by Shen to allow a user to adapt to different wearing requirements, improving comfort level of the patient (Shen, Page 3 Paragraph 7).
Modified Bierman in view of Shen and Peterson does not expressly disclose wherein a plurality of connecting seats are arranged on the fitting component and provided with the plugging holes, and one end of each of the strip plates that is connected with the fitting component is provided with a first protrusion portion after passing through the plugging holes.
However, Shen teaches wherein a plurality of connecting seats (142) are arranged on the connecting portion (12) and provided with the plugging holes (inside of 142, Fig. 3), and one end of each of the fitting component that is connected with the strip plates (12) is provided with a first protrusion portion (hooked end of 141, Fig. 3) after passing through the plugging holes (Fig. 1).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by modified Bierman and Peterson wherein a plurality of connecting seats are arranged on the fitting component and provided with the plugging holes, and one end of each of the strip plates that is connected with the fitting component is provided with a first protrusion portion after passing through the plugging holes since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Shen and Peterson, further In view of Park (KR 20200114207 A)
Regarding Claim 8, modified Bierman in view of Shen and Peterson discloses the fixing device for double-tube intubation according to claim 7.
Modified Bierman in view of Shen and Peterson does not expressly disclose wherein bending portions are arranged in the strip plates and extend to auricle.
Park teaches wherein bending portions (220) are arranged in the strip plates (Fig. 2) and extend to auricle (Fig. 4).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by modified Bierman in view of Shen and Peterson wherein bending portions are arranged in the strip plates and extend to auricle as taught by Park so that the fixing device can be brought into close contact with the face in response to various curves of the face (Park, Page 5 Paragraph 5).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Shen and Peterson, further in view of Yu (KR 20200124452 A).
Regarding Claim 11, modified Bierman in view of Shen and Peterson discloses the fixing device for double-tube intubation according to claim 10,
Modified Bierman in view of Shen and Peterson does not expressly disclose wherein at least two limiting members are provided, and openings of the limiting members are located on both sides of the strip plates in respective.
Yu teaches wherein at least two limiting members are provided (14), and openings of the limiting members are located on both sides of the strip plates in respective (14 located on left attachment plate 12 and right attachment plate 13 respectively in Fig. 6).
Additionally, “The auxiliary coupling part 14 may be formed in a ring shape with one side open to surround the circular tube as shown in FIG. 6, for example. The ring shape with an open side is easy to fit by inserting a tube made of silicon, and can be firmly fixed even if a tube having a large diameter is mounted due to the structure in which the ring can be opened. In addition, if necessary, the auxiliary coupling portion 14 may be a type of wrapping the tube in a Velcro string type, or may have a concave groove in which the tube can be placed.” – Yu, Page 6 Paragraph 4.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixing device for double-tube intubation disclosed by Modified Bierman in view of Shen and Peterson wherein at least two limiting members are provided, and openings of the limiting members are located on both sides of the strip plates in respective as taught by Yu so that the tubing is fixed to the strip plates preventing movement (Yu, Page 6 Paragraph 8).
Conclusion
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/MARK GOLOVAN/Patent Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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