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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted July 28, 2023 and July 12, 2024 have been received and considered by the Examiner.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I – Claim 1-14, drawn to a gauze placement apparatus comprising: an upper handle connected to a lower fork extension, a lower handle connected to an upper fork extension, each fork extension comprising: a fork portion and a pair of aligned prongs
Group II – Claims 15-18, drawn to a gauze placement apparatus comprising: an upper handle connected to a lower fork extension, a lower handle connected to an upper fork extension; each fork extension comprising: a fork portion and a pair of aligned prongs that curve upwardly
Group III – Claims 19-20, drawn to a method of placing gauze on a patient comprising: providing a gauze placement apparatus comprising: an upper handle connected to a lower fork extension, a lower handle connected to an upper fork extension, each fork extension comprising: a fork portion and a pair of aligned prongs; moving the handles apart into an open position; placing a slit gauze on the lower prongs; moving the handles towards each other into a closed position; and positioning the slit gauze on between the patient and medical equipment.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a gauze placement apparatus, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Li (US 20110230725 A1).
Li discloses: A gauze placement apparatus (Paragraph 0020, Illustrative embodiments herein are generally directed to medical devices and surgical methods that enable a medical technician to retract and/or fixate a particular area so that it is easier to work with the particular area […] The surgical instrument disclosed has a handle to be used by a technician to manipulate a working end. The working end is configured to be placed at the particular site of interest […] In one embodiment, the working end is configured to hold, alternatively or additionally, other objects such as, but not limited to, a sponge or bandage, a surgical tube, a piece of artificial tissue for grafting, a transplant organ, and the like) comprising:
an upper handle (Annotated Figure 1, opposing handle end 104b) connected to a lower fork extension (Annotated Figure 1, Paragraph 0039, The surgical instrument 100 provided in the present disclosure includes a first elongated member 110 and a second elongated member 120. Each elongated member 110, 120 includes an engaging end 102a, 102b and an opposing handle end 104a, 104b, connected by an elongated portion 106a, 106b, respectively);
the lower fork extension comprising a fork portion (Paragraph 0042, FIG. 1 is only an illustrative example of constructing the engaging ends 102a, 102b and some other alternatives are described further below and various other configurations will be understood by those of skill in the art based on the present disclosure) and first and second lower prongs (Paragraph 0053, Turning to FIGS. 6A through 6B, other embodiments of engaging ends 600a, 600b are shown […] As mentioned above, the partially circumscribed opening may be configured in any suitable shape and size adapted to the area subject to a surgical operation and/or the object to be held) aligned with each other in a second direction that is transverse to a first direction in which the upper handle is oriented (Annotated Figure 6A, engaging ends 610b);
a lower handle (Annotated Figure 1, opposing handle end 104a), (Paragraph 0055, FIGS. 7 through 10 show illustrative embodiments of the handle of the surgical instrument provided in the present disclosure. The handle end of the first elongated member and the handle end of the second elongated member may act in conjunction to provide a handle. The handle ends may be in any suitable size and form to enable a user or technician to hold the surgical instrument. In some embodiments, one or more of the handle ends may include a finger ring) connected to an upper fork extension (Annotated Figure 1, Paragraph 0039, The surgical instrument 100 provided in the present disclosure includes a first elongated member 110 and a second elongated member 120. Each elongated member 110, 120 includes an engaging end 102a, 102b and an opposing handle end 104a, 104b, connected by an elongated portion 106a, 106b, respectively);
the upper fork extension comprising a fork portion (Paragraph 0053, Turning to FIGS. 6A through 6B, other embodiments of engaging ends 600a, 600b are shown […] As mentioned above, the partially circumscribed opening may be configured in any suitable shape and size adapted to the area subject to a surgical operation and/or the object to be held) and first and second upper prongs aligned with each other in the second direction that is transverse to the first direction in which the lower handle is oriented (Figures 6A-6B, engaging ends 610a, 620a);
the upper handle and the lower fork extension being pivotally connected to the lower handle and the upper fork extension such that the upper handle resides above the lower handle and the upper fork extension resides above the lower fork extension (Paragraph 0039, The first elongated member 110 and the second elongated member 120 are interconnected through a connector 130 located between the engaging ends 102a, 102b and the handle ends 104a, 104b, and are configured to pivot around the connector 130. Thus, the connector 130 forms a pivot axis around which the first and second elongated members 110, 120, respectively, are pivotably connected) so that,
when the upper handle and lower handle are moved in a diverging direction, the upper and lower fork extensions move apart from each other to an open position (Figure 12) and, when the upper handle and lower handle are moved in a converging direction, the upper and lower fork extensions move toward each other to a closed position (Figure 11), (Paragraph 0043, The engaging end 102a of the first elongated member 110 and the engaging end 102b of the second elongated member 120 operate in conjunction to provide a working end 102. The handle end 104a of the first elongated member 110 and the handle end 104b of the second elongated member 120 operate in conjunction to provide a handle 104. As described below, a technician manipulates handle 104 which, due to the pivotable connection in the first and second elongated members 110, 120, operates to move the working end 102 between an open or unengaged state and a closed or engaged state. The engaging ends 102a, 102b are configured to operably engage with each other to hold an object);
and the first and second lower prongs of the lower fork extension configured to receive a first folded gauze with a slit on a folded side of the folded gauze such that the slit resides between the first and second lower prongs and the upper and lower fork extensions (Paragraph 0054, FIGS. 6A and 6B also show some illustrative embodiments of engaging ends 610b, 620b. The engaging ends 610b, 620b are configured to at least partially correspond to the engaging ends 610a, 620a. In one illustrative embodiment, engaging end 610b may also include a partially circumscribed opening 618 of the same shape/contour as the partially circumscribed opening 616 of the engaging end 610a, as shown in FIG. 6A) configured to hold the first folded gauze when in the closed position (Paragraph 0053, As discussed above, a partially circumscribed opening may provide more access to an area near the gap than a completely circumscribed opening. Alternatively or additionally, a partially circumscribed opening may provide a different ability to engage an object being held by the surgical instrument. As mentioned above, the partially circumscribed opening may be configured in any suitable shape and size adapted to the area subject to a surgical operation and/or the object to be held)
PNG
media_image1.png
785
869
media_image1.png
Greyscale
Li Annotated Figure 1
PNG
media_image2.png
286
468
media_image2.png
Greyscale
Li Annotated Figure 6A
During a telephone conversation with David Sigmon on February 10, 2026, a provisional election was made without traverse to prosecute the invention of Group I, Claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claims 3 and 9-13 are objected to because of the following informalities:
Claim 3, “each comprise a shank an insertion tip” should read “each comprise a shank and an insertion tip”.
Claims 9-13, “first and second lower prongs” should read “the first and second lower prongs” at multiple instances
Claims 9-11, “first and second upper prongs” should read “the first and second upper prongs” at multiple instances.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20110230725 A1) in view of Kao et al. (US 20170312150 A1, hereinafter “Kao”).
Regarding Claim 1, Li discloses: A gauze placement apparatus (Paragraph 0020, Illustrative embodiments herein are generally directed to medical devices and surgical methods that enable a medical technician to retract and/or fixate a particular area so that it is easier to work with the particular area […] The surgical instrument disclosed has a handle to be used by a technician to manipulate a working end. The working end is configured to be placed at the particular site of interest […] In one embodiment, the working end is configured to hold, alternatively or additionally, other objects such as, but not limited to, a sponge or bandage, a surgical tube, a piece of artificial tissue for grafting, a transplant organ, and the like) comprising:
an upper handle (Annotated Figure 1, opposing handle end 104b) connected to a lower fork extension (Annotated Figure 1, Paragraph 0039, The surgical instrument 100 provided in the present disclosure includes a first elongated member 110 and a second elongated member 120. Each elongated member 110, 120 includes an engaging end 102a, 102b and an opposing handle end 104a, 104b, connected by an elongated portion 106a, 106b, respectively);
a lower handle (Annotated Figure 1, opposing handle end 104a), (Paragraph 0055, FIGS. 7 through 10 show illustrative embodiments of the handle of the surgical instrument provided in the present disclosure. The handle end of the first elongated member and the handle end of the second elongated member may act in conjunction to provide a handle. The handle ends may be in any suitable size and form to enable a user or technician to hold the surgical instrument. In some embodiments, one or more of the handle ends may include a finger ring) connected to an upper fork extension (Annotated Figure 1, Paragraph 0039, The surgical instrument 100 provided in the present disclosure includes a first elongated member 110 and a second elongated member 120. Each elongated member 110, 120 includes an engaging end 102a, 102b and an opposing handle end 104a, 104b, connected by an elongated portion 106a, 106b, respectively);
the lower fork extension comprising a fork portion (Paragraph 0042, FIG. 1 is only an illustrative example of constructing the engaging ends 102a, 102b and some other alternatives are described further below and various other configurations will be understood by those of skill in the art based on the present disclosure) and first and second lower prongs (Paragraph 0053, Turning to FIGS. 6A through 6B, other embodiments of engaging ends 600a, 600b are shown […] As mentioned above, the partially circumscribed opening may be configured in any suitable shape and size adapted to the area subject to a surgical operation and/or the object to be held) aligned with each other in a second direction that is transverse to a first direction in which the upper handle is oriented (Annotated Figures 6A-6B, engaging ends 610b, 620b);
the upper fork extension comprising a fork portion (Paragraph 0053, Turning to FIGS. 6A through 6B, other embodiments of engaging ends 600a, 600b are shown […] As mentioned above, the partially circumscribed opening may be configured in any suitable shape and size adapted to the area subject to a surgical operation and/or the object to be held) and first and second upper prongs aligned with each other in the second direction that is transverse to the first direction in which the lower handle is oriented (Figures 6A-6B, engaging ends 610a, 620a);
the upper handle and the lower fork extension being pivotally connected to the lower handle and the upper fork extension such that the upper handle resides above the lower handle and the upper fork extension resides above the lower fork extension (Paragraph 0039, The first elongated member 110 and the second elongated member 120 are interconnected through a connector 130 located between the engaging ends 102a, 102b and the handle ends 104a, 104b, and are configured to pivot around the connector 130. Thus, the connector 130 forms a pivot axis around which the first and second elongated members 110, 120, respectively, are pivotably connected) so that,
when the upper handle and lower handle are moved in a diverging direction, the upper and lower fork extensions move apart from each other to an open position (Figure 12) and, when the upper handle and lower handle are moved in a converging direction, the upper and lower fork extensions move toward each other to a closed position (Figure 11), (Paragraph 0043, The engaging end 102a of the first elongated member 110 and the engaging end 102b of the second elongated member 120 operate in conjunction to provide a working end 102. The handle end 104a of the first elongated member 110 and the handle end 104b of the second elongated member 120 operate in conjunction to provide a handle 104. As described below, a technician manipulates handle 104 which, due to the pivotable connection in the first and second elongated members 110, 120, operates to move the working end 102 between an open or unengaged state and a closed or engaged state. The engaging ends 102a, 102b are configured to operably engage with each other to hold an object);
and the first and second lower prongs of the lower fork extension configured to receive a first folded gauze with a slit on a folded side of the folded gauze such that the slit resides between the first and second lower prongs and the upper and lower fork extensions (Paragraph 0054, FIGS. 6A and 6B also show some illustrative embodiments of engaging ends 610b, 620b. The engaging ends 610b, 620b are configured to at least partially correspond to the engaging ends 610a, 620a. In one illustrative embodiment, engaging end 610b may also include a partially circumscribed opening 618 of the same shape/contour as the partially circumscribed opening 616 of the engaging end 610a, as shown in FIG. 6A) configured to hold the first folded gauze when in the closed position (Paragraph 0053, As discussed above, a partially circumscribed opening may provide more access to an area near the gap than a completely circumscribed opening. Alternatively or additionally, a partially circumscribed opening may provide a different ability to engage an object being held by the surgical instrument. As mentioned above, the partially circumscribed opening may be configured in any suitable shape and size adapted to the area subject to a surgical operation and/or the object to be held)
Though Li does not explicitly disclose a first folded gauze with a slit, the disclosed surgical instrument is capable of being configured in a range of shapes (Paragraph 0053, Illustrative shapes of the partially circumscribed opening may include, but are not limited to, a partial ellipse, partial circle, partial square, partial triangle, an irregular shape, or other shape. This may result in embodiments of the engaging ends 610a, 620a having a "C" shape (FIG. 6A), or "V" shape (FIG. 6B) which are provided as illustrative examples. While these standard shapes are provided as examples, the partially circumscribed opening can also be an irregular shape to fit a particular site or purpose such as irregular formations in skin, tissue, muscle, and the like. Other configurations of shape and/or curvature are possible for engaging ends 610a, 620a in light of the disclosure herein) that can be configured to hold the gauze between the prongs (Paragraph 0020, In one embodiment, the working end is configured to hold, alternatively or additionally, other objects such as, but not limited to, a sponge or bandage, a surgical tube, a piece of artificial tissue for grafting, a transplant organ, and the like).
This is further exemplified by Kao’s disclosed invention, which teaches a Y-shaped structure intended for user around tracheostomy equipment that allows for a caregiver to apply a folded gauze with a slit (Paragraph 0008, According to an embodiment of the invention, the Y-type gauze comprises a gauze body and a cutting notch, the gauze body is folded to form a multi-layer structure having at least one crease, the cutting notch extends from an edge of the gauze body where the at least one crease exists to a center of the gauze body so as to form two gauze branches, when the Y-type gauze positioning rod is disposed in the multi-layer structure of the Y-type gauze, the two supporting branches of the Y-type gauze positioning rod are located in the two gauze branches of the Y-type gauze, and a part of the holder is exposed from the Y-type gauze).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Kao to utilize the surgical equipment described by Li as a means of positioning gauze around a tracheostomy equipment without disturbing or causing discomfort to a user (Paragraph 0028, the caregiver needs to raise the tracheostomy tube by hand or bamboo sticks due to space limitation between the tracheostomy tube and the skin of the neck, so that Y-type gauze is able to pass through the space between the tracheostomy tube and the skin of the neck. However, this kind of motion may causes the patient uncomfortable easily and respiratory tract infection. The Y-type gauze positioning assembly 10 and the Y-type gauze positioning rod 100 of the invention are able to assist to place the Y-type gauze 20 to an affected area without moving the tracheostomy tube).
Regarding Claim 2, Li in view of Kao discloses all of the limitations of Claim 1. Li further discloses: wherein the first and second upper prongs of the upper fork extension are configured to receive a second folded gauze with a slit on a folded side of the second folded gauze (Paragraph 0053, Turning to FIGS. 6A through 6B, other embodiments of engaging ends 600a, 600b are shown. […] As discussed above, a partially circumscribed opening may provide more access to an area near the gap than a completely circumscribed opening. Alternatively or additionally, a partially circumscribed opening may provide a different ability to engage an object being held by the surgical instrument) such that the slit resides between the first and second upper prongs and the upper and lower fork extensions configured to hold the second folded gauze (Paragraph 0053, the partially circumscribed opening may be configured in any suitable shape and size adapted to the area subject to a surgical operation and/or the object to be held […] This may result in embodiments of the engaging ends 610a, 620a having a "C" shape (FIG. 6A), or "V" shape (FIG. 6B) which are provided as illustrative examples. While these standard shapes are provided as examples, the partially circumscribed opening can also be an irregular shape to fit a particular site or purpose such as irregular formations in skin, tissue, muscle, and the like. Other configurations of shape and/or curvature are possible for engaging ends 610a, 620a in light of the disclosure herein) when in the closed position (Paragraph 0043, a technician manipulates handle 104 which, due to the pivotable connection in the first and second elongated members 110, 120, operates to move the working end 102 between an open or unengaged state and a closed or engaged state. The engaging ends 102a, 102b are configured to operably engage with each other to hold an object).
Regarding Claim 3, Li in view of Kao discloses all of the limitations of Claim 1. Li further discloses: wherein the first and second upper prongs of the upper fork extension each comprise a shank and an insertion tip and the first and second lower prongs of the lower fork extension each comprise a shank an insertion tip (Annotated Figure 1)
and wherein the first upper prong (Figure 6A, engaging ends 610a) aligns with the first lower prong (Figure 6A, engaging ends 610b) in the first direction transverse to the second direction in which the first and second upper prongs are aligned and the second upper prong (Figure 6A, engaging ends 610a) aligns with the second lower prong (Figure 6A, engaging ends 610b) in the first direction transverse to the second direction in which the first and second upper prongs are aligned (Paragraph 0054, FIGS. 6A and 6B also show some illustrative embodiments of engaging ends 610b, 620b. The engaging ends 610b, 620b are configured to at least partially correspond to the engaging ends 610a, 620a. In one illustrative embodiment, engaging end 610b may also include a partially circumscribed opening 618 of the same shape/contour as the partially circumscribed opening 616 of the engaging end 610a, as shown in FIG. 6A […] However, as mentioned above, the engaging ends 610b, 620b may also be larger than, or equal to the engaging ends 610a, 620a).
Regarding Claim 4, Li in view of Kao discloses all of the limitations of Claim 3. Li further discloses: wherein the insertion tip of the first upper prong and the insertion tip of the first lower prong converge in the closed position (Paragraph 0043, a technician manipulates handle 104 which, due to the pivotable connection in the first and second elongated members 110, 120, operates to move the working end 102 between an open or unengaged state and a closed or engaged state. The engaging ends 102a, 102b are configured to operably engage with each other to hold an object).
Li broadly discloses the insertion tip of the second upper prong and the insertion tip of the second lower prong converge in the closed position being capable of facilitate[ing] insertion of one or more gauzes between a patient and a portion of medical equipment (Paragraph 0053, Alternatively or additionally, a partially circumscribed opening may provide a different ability to engage an object being held by the surgical instrument. As mentioned above, the partially circumscribed opening may be configured in any suitable shape and size adapted to the area subject to a surgical operation and/or the object to be held […] While these standard shapes are provided as examples, the partially circumscribed opening can also be an irregular shape to fit a particular site or purpose such as irregular formations in skin, tissue, muscle, and the like)
Kao more explicitly discloses facilitat[ing] insertion of one or more gauzes between a patient and a portion of medical equipment (Paragraph 0028, the caregiver needs to raise the tracheostomy tube by hand or bamboo sticks due to space limitation between the tracheostomy tube and the skin of the neck, so that Y-type gauze is able to pass through the space between the tracheostomy tube and the skin of the neck. However, this kind of motion may cause the patient uncomfortable easily and respiratory tract infection. The Y-type gauze positioning assembly 10 and the Y-type gauze positioning rod 100 of the invention are able to assist to place the Y-type gauze 20 to an affected area without moving the tracheostomy tube).
Regarding Claim 5, Li in view of Kao discloses all of the limitations of Claim 4. Li further discloses: wherein the shank of the first upper prong and the shank of the first lower prong are spaced apart in the closed position and the shank of the second upper prong and the shank of the second lower prong are spaced apart in the closed position such that a separation space (Figure 11, gap 1140) is formed between portions of the upper fork extension and the lower fork extension when the upper and lower extensions are in the closed position (Paragraph 0063, In certain embodiments, at least a portion of the elongated portion 1106a connecting the engaging end 1102a and the handle end 1104a of the first elongated member 1110 and/or the elongated portion 1106b connecting the engaging end 1102b and the handle end 1104b of the second elongated member 1120 may be curved and/or bent such that when the engaging end 1102a and the engaging end 1102b come in close proximity with each other, e.g. in a closed or engaged state, there is a gap 1140 between the at least a portion of the elongated portion 1106a of the first elongated member 1110 and the elongated portion 1106b of the second elongated member 1120. By creating such a gap 1140, additional tissues and/or other objects may be held there. This may allow access to deeper location and/or otherwise facilitate surgical procedures)
Regarding Claim 6, Li in view of Kao discloses all of the limitations of Claim 3. Li further discloses: wherein the first and second lower prongs of the lower fork extension are separated by a distance large enough to permit the first and second lower prongs to be inserted on either side of a surgical site on a patient (Paragraph 0028, The partially or completely circumscribed opening can be in the shape of, for example, an ellipse, a circle, a square, and a triangle with round corner contour. While these standard shapes are provided as examples, the partially or completely circumscribed opening can be in an irregular shape to fit a particular site or purpose such as irregular formations in skin, tissue, muscle, and the like. The length or diameter of the partially or completely circumscribed opening can be in the range of about 1 cm to about 50 cm, about 2 cm to about 40 cm, about 3 cm to about 30 cm, about 5 cm to about 15 cm, about 1 cm to about 10 cm, about 1 cm to about 6 cm, or about 2 cm to about 5 cm, e.g. approximately 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 10 cm, or 15 cm, as illustrative examples)
and the first and second upper prongs of the upper fork extension are separated by a distance large enough to permit the first and second lower prongs to be inserted on either side of a surgical site on a body of a patient for placement of one or more gauzes around the surgical site (Paragraph 0025, So, in some embodiments, for smaller and/or thinner objects, the engaging ends may be "engaged" when they are about 0 mm to about 10 mm apart, about 1 mm apart to about 9 mm apart, or about 2 mm apart to about 8 mm apart, as illustrative examples. In one embodiment, the object may be thin enough that the engaging end of the second elongated member may pass through an at least partially circumscribed opening of the engaging end of the first elongated member, pushing a portion of the object through the at least partially circumscribed opening, as detailed below. In another embodiment, where the engaging ends are holding a larger object, the engaging ends may be engaged when they are about 10 mm apart to about 50 mm apart or even farther apart. For example, if the surgical instrument is configured for a larger surgical site, the engaging ends may be about 5 cm to about 20 cm apart, while holding an object to thereby become engaged).
Kao more explicitly discloses a tube inserted into a patient (Paragraph 0026, FIGS. 6 and 7 are schematic views illustrating the Y-type gauze being placed beside a tracheostomy tube by the Y-type gauze positioning rod of FIG. 1) and placement of one or more gauzes around the tube (Paragraph 0028, the caregiver needs to raise the tracheostomy tube by hand or bamboo sticks due to space limitation between the tracheostomy tube and the skin of the neck, so that Y-type gauze is able to pass through the space between the tracheostomy tube and the skin of the neck. However, this kind of motion may causes the patient uncomfortable easily and respiratory tract infection. The Y-type gauze positioning assembly 10 and the Y-type gauze positioning rod 100 of the invention are able to assist to place the Y-type gauze 20 to an affected area without moving the tracheostomy tube).
Regarding Claim 14, Li in view of Kao discloses all of the limitations of Claim 1. Li further discloses: wherein the handles comprise hand inserts (Paragraph 0055, FIGS. 7 through 10 show illustrative embodiments of the handle of the surgical instrument provided in the present disclosure. The handle end of the first elongated member and the handle end of the second elongated member may act in conjunction to provide a handle. The handle ends may be in any suitable size and form to enable a user or technician to hold the surgical instrument. In some embodiments, one or more of the handle ends may include a finger ring. In some embodiments, one or more of the handle ends may be elongated and include a gripping surface and/or transverse ridges) to move the upper and lower fork extensions between the open position to the closed position (Paragraph 0043, As described below, a technician manipulates handle 104 which, due to the pivotable connection in the first and second elongated members 110, 120, operates to move the working end 102 between an open or unengaged state and a closed or engaged state. The engaging ends 102a, 102b are configured to operably engage with each other to hold an object).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20110230725 A1) in view of Kao (US 20170312150 A1), further in view of Hanneman et al. (US 7093598 B1, hereinafter “Hanneman”).
Regarding Claim 7, Li in view of Kao discloses all of the limitations of Claim 1. Li further discloses: wherein the first and second lower prongs of the lower fork extension and the first and second upper prongs of the upper fork extension curve upward (Paragraph 0053, Other configurations of shape and/or curvature are possible for engaging ends 610a, 620a in light of the disclosure herein)
However, Li in view of Kao does not explicitly disclose the fork extensions curv[ing] upward to facilitate insertion of one or more gauzes around a tube inserted into a body of a patient.
Hanneman does disclose wherein the fork extensions (Figure 2, prongs 36a, 36b) curve upward to facilitate insertion (Column 2, lines 26-34, On the distal end of the shoulder, extending away or distally from that distal end of the shoulder, and curving in an upward direction relative to the shoulder, are two prongs. Each prong has an inner and an outer edge. The prongs are parallel to one another and generally form a "U"-shape. Most trach tubes have a certain diameter and, in the preferred embodiment, the prongs are separated by a distance wider than the distance of the diameter of the trach tube. In this manner the prongs easily fit around the trach tube) of one or more gauzes around a tube inserted into a body of a patient (Column 2, lines 39-44, Moreover, the prongs fit within the typical trach drainage sponge. A typical trach drainage sponge has two sheaths, an upper sheath and a lower sheath. The prongs fit between the sheaths with the top sheath resting on the prongs. This allows the user of the device to insert the dressing and the sponge in a simple, smooth manner).
As described above, Li envisions various embodiments of the surgical instrument’s engaging ends in different shapes in accordance with a user’s needs. It would have been obvious to one skilled in the art before the effective filing date to incorporate the curved structure of the trach drain sponge applicator taught by Hanneman with the device disclosed by Li in view of Kao, so as to better accommodate the anatomy of a patient comfortably without disrupting the inserted medical tubing.
Claims 8-9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20110230725 A1) in view of Kao (US 20170312150 A1), in view of Hanneman (US 7093598 B1), further in view of Thrasher (US 20190365401 A1).
Regarding Claim 8, Li in view of Kao and Hanneman discloses all of the limitations of Claim 8. Hanneman further discloses: wherein the prongs have an inner radius of curvature and an outer radius of curvature (Column 2, lines 26-30, On the distal end of the shoulder, extending away or distally from that distal end of the shoulder, and curving in an upward direction relative to the shoulder, are two prongs. Each prong has an inner and an outer edge. The prongs are parallel to one another and generally form a "U"-shape).
It would have been obvious to one of ordinary skill in the art to apply the curvature taught by Hanneman to the both the upper and lower prongs disclosed by Li.
This structure is further demonstrated by Thrasher: wherein the first and second lower prongs of the lower fork extension (Figure 15, Paragraph 0043, Pincers 28A, 28B are disposed at the distal end 16 of arm 12) each has an inner radius of curvature and an outer radius of curvature and the first and second upper prongs of the upper fork extension (Figure 15, Paragraph 0043, Similarly, pincers 26A, 26B are disposed at the distal end of arm 14) each has an inner radius of curvature and an outer radius of curvature (Paragraph 0043, pincers 26A, 26B, 28A, 28B can be angled in an upwardly or downwardly direction out of planarity with the tool body of the forceps 10), (Paragraph 0036, FIGS. 9-10 provide perspective views of in-use illustrations for the forceps 10. As discussed above, the pincers 26A, 26B, 28A, 28B have an arcuate shape bending generally outwardly from planarity with the body of the forceps 10. The bend angle can be anywhere from 15-60 degrees, and preferably 30-45 degrees relative to the handles 22, 24 as illustrated pictorially in FIGS. 9-10).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the Thrasher’s angled double forceps structure so as to provide an embodiment of curved prongs as envisioned by Li and Hanneman. Furthermore, the curved prong structure enables additional movement and functionality in different medical applications (Paragraph 0036,The bend angle allows manipulation of tissues, nerves, fluids, and other possible vision-occluders to the extent that would not otherwise be possible with straight pincers or pincers with a zero-degree bend. Illustrated holding a plurality of fibrous swabs 62, such as a plurality of cotton peanut sponges, cotton kittners or any like fibrous sponges/swabs, is a swab pouch 60).
Regarding Claim 9, Li in view of Kao, Hanneman, and Thrasher discloses all of the limitations of Claim 8. Li discloses embodiments of the first and second lower prongs and first and second upper prongs (Figure 6A, engaging ends 610a, 610b) in which there is curvature (Paragraph 0053, Other configurations of shape and/or curvature are possible for engaging ends 610a, 620a in light of the disclosure herein), but does not explicitly describe the inner and outer radii of curvature of the prongs or whether the ends are blunt.
Hanneman does disclose wherein the inner radii of curvature of the first and second [lower and upper] prongs are greater than the outer radii of curvature of the first and second [lower and upper] prongs (Annotated Figure 4, Column 3, lines 64-67, The prongs also curve in an upward direction towards the distal end relative to the shoulder 34 and the body 30. This upward curve can be seen clearly in FIGS. 2 and 4).
such that upper and lower outer surfaces of first and second [lower and upper] prongs converge toward blunt ends of the respective first and second [lower and upper] prongs (Column 3, lines 56-63, The distal end 60 of the shoulder has two prongs 36a, 36b extending in a distal direction. While in this preferred embodiment, the prongs are smooth because of the design of the trach drainage sponge 24 associated with the device 30, in other embodiments, the prongs may be different shapes or textures. The prongs have a top side 66a, 66b and a bottom side 68a, 68b. The prong tips are shown to each have a flat edge 70. However, the prongs may have curved edges).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the curved and blunted structure of Hanneman with the quadruple-pronged surgical instrument disclosed by Li so as to better accommodate the anatomy of a patient comfortably, to make it easier to maneuver around medical equipment, and to better hold different types of gauze and sponges (Column 4, lines 58-60, As mentioned before, the prongs may have curved edges. It is important that the design of the prong edges do not pierce the sponge).
PNG
media_image3.png
378
719
media_image3.png
Greyscale
Hanneman Annotated Figure 4
Regarding Claim 11, Li in view of Kao, Hanneman, and Thrasher discloses all of the limitations of Claim 8. Li further discloses the apparatus is placeable without the fork portion of the lower fork extension (Paragraph 0064, As shown in FIG. 11, the elongated portions 1106a, 1106b are longitudinally angled and form an angle A and an angle B, respectively. While the angles A, B are shown being formed at the connector 1130, the angling points do not necessarily need to be formed near the connector 120; rather the angles A, B may be formed elsewhere along the elongated portions 1106a, 1106b. In some embodiments, angles A and B are of the same degree. In some other embodiments, angles A and B are of different degrees, e.g. when at least a portion of elongated portions 1106a and/or elongated portion 1106b is curved or bent and a gap 1140 is present therebetween, as shown in FIG. 11) or the lower handle abutting the body of the patient (Paragraph 0063, there is a gap 1140 between the at least a portion of the elongated portion 1106a of the first elongated member 1110 and the elongated portion 1106b of the second elongated member 1120. By creating such a gap 1140, additional tissues and/or other objects may be held there. This may allow access to deeper location and/or otherwise facilitate surgical procedures).
Li also discloses embodiments of the first and second lower prongs (Figure 6A, engaging ends 610a) and first and second upper prongs (Figure 6A, engaging ends 610b) in which there is curvature (Paragraph 0053, Other configurations of shape and/or curvature are possible for engaging ends 610a, 620a in light of the disclosure herein), but does not explicitly describe the inner and outer radii of curvature of the prongs, or whether the ends are blunt.
Hanneman does disclose:
wherein the outer radii of curvature of first and second [lower] prongs of the [lower] fork extensions (Column 2, lines 26-34, On the distal end of the shoulder, extending away or distally from that distal end of the shoulder, and curving in an upward direction relative to the shoulder, are two prongs. Each prong has an inner and an outer edge. The prongs are parallel to one another and generally form a "U"-shape. Most trach tubes have a certain diameter and, in the preferred embodiment, the prongs are separated by a distance wider than the distance of the diameter of the trach tube. In this manner the prongs easily fit around the trach tube) and lengths of the first and second [upper and lower] prongs of the [upper and lower] fork extensions (Column 4, lines 32-48, FIG. 3 shows the overall length A of the device, the length B of the prongs, the width C of the prongs, and the width D between the prongs […] In general, it is desirable that the width B only be slightly greater than the diameter of the tube. In addition, it is desirable that the width C of the prongs be wide enough so as to assist in advancing the sponge and doing so without piercing the sponge material. However, it is also desirable that the width C of the prongs not be so great as to interfere with the ability of sliding the device under the plate and strap) are such that
the blunt ends of first and second [lower and upper] prongs (Column 3, lines 62-63, The prong tips are shown to each have a flat edge 70. However, the prongs may have curved edges (not shown)), (Column 4, lines 58-60, As mentioned before, the prongs may have curved edges. It is important that the design of the prong edges do not pierce the sponge)) can be inserted are insertable under portions of a tracheostomy equipment and a slit gauze (Column 4, lines 17-31, A prior art trach drainage sponge 24 is shown in FIGS. 7 and 8. […] FIG. 8 shows the sponge in a partially open position and shows the inside surface 84, a seam or pocket 86, a longitudinally extending slit 88 and two transverse slits 90. The seam defines an upper sheath 92 and lower sheath 94. The upper sheath is folded along the seam upon the lower sheath, wherein the transverse slits are aligned with one another when in the closed position shown in FIG. 7) on the [upper] prongs placed is placeable around a tube of the tracheostomy equipment with the base of the slit against the tube (Figure 9, Column 5, lines 15-24, As the user advances the device and sponge underneath the plate of the tracheostomy tube and band, the user will bring the handle downward in a manner so as to maintain a substantially parallel relationship with the tangent formed by the portion of the prongs directly underneath the shoulder of the tracheostomy tube. Once the sponge is in position about the tracheostomy tube, the user may hold the sponge in place while withdrawing the device from the sponge and tracheostomy tube) without the fork portion of the [lower] fork extension or the [lower] handle abutting the body of the patient (Column 4, lines 15-16, The profile of the concave shape is designed to conform to the profile or shape of a patient's neck)
Regarding Claim 12, Li in view of Kao, Hanneman, and Thrasher discloses all of the limitations of Claim 11. Li further discloses a broad range of angles for the lower fork extension (Paragraph 0064, As shown in FIG. 11, the elongated portions 1106a, 1106b are longitudinally angled and form an angle A and an angle B, respectively. While the angles A, B are shown being formed at the connector 1130, the angling points do not necessarily need to be formed near the connector 120; rather the angles A, B may be formed elsewhere along the elongated portions 1106a, 1106b. In some embodiments, angles A and B are of the same degree. In some other embodiments, angles A and B are of different degrees, e.g. when at least a portion of elongated portions 1106a and/or elongated portion 1106b is curved or bent and a gap 1140 is present therebetween, as shown in FIG. 11).
Likewise, Hanneman discloses a variety of possible dimensions for the first and second [lower] prongs (Column 4, lines 32-48, FIG. 3 shows the overall length A of the device, the length B of the prongs, the width C of the prongs, and the width D between the prongs […] In general, it is desirable that the width B only be slightly greater than the diameter of the tube. In addition, it is desirable that the width C of the prongs be wide enough so as to assist in advancing the sponge and doing so without piercing the sponge material. However, it is also desirable that the width C of the prongs not be so great as to interfere with the ability of sliding the device under the plate and strap) curve upward from the fork portion of the [lower] fork extension such that a vertical distance from a plane extends from an outer surface of a base of the fork portion of the [lower] fork extension to the blunt ends of first and second [lower] prongs (Column 2, lines 26-34, On the distal end of the shoulder, extending away or distally from that distal end of the shoulder, and curving in an upward direction relative to the shoulder, are two prongs. Each prong has an inner and an outer edge. The prongs are parallel to one another and generally form a "U"-shape. Most trach tubes have a certain diameter and, in the preferred embodiment, the prongs are separated by a distance wider than the distance of the diameter of the trach tube. In this manner the prongs easily fit around the trach tube)
The combination does not explicitly disclose a vertical distance […] is about 2 inches or more. However, based on the various envisioned embodiments described by to accommodate different users (Hanneman, Column 2, lines 35-38, Furthermore, since the device is preferably made of plastic, it can be molded inexpensively and quickly to fit various size and shapes of trach tubes--i.e. a medical professional likely will require a smaller device for a child) and equipment (Li, Paragraph 0024, Objects can also include other medical devices used for performing a medical procedure including, but not limited to, a sponge or bandage, a surgical tube, a piece of artificial tissue for grafting, a transplant organ, and the like), it would have been prima facie obvious to one skilled in the art before the effective filing date to incorporate a range of vertical distance measures including “about 2 inches or more”.
Regarding Claim 13, Li in view of Kao, Hanneman, and Thrasher discloses all of the limitations of Claim 11. Li further discloses a broad range of angles for the lower fork extension (Paragraph 0064, As shown in FIG. 11, the elongated portions 1106a, 1106b are longitudinally angled and form an angle A and an angle B, respectively. While the angles A, B are shown being formed at the connector 1130, the angling points do not necessarily need to be formed near the connector 120; rather the angles A, B may be formed elsewhere along the elongated portions 1106a, 1106b. In some embodiments, angles A and B are of the same degree. In some other embodiments, angles A and B are of different degrees, e.g. when at least a portion of elongated portions 1106a and/or elongated portion 1106b is curved or bent and a gap 1140 is present therebetween, as shown in FIG. 11).
Likewise, Hanneman discloses a variety of possible dimensions for the first and second [lower] prongs (Column 4, lines 32-48, FIG. 3 shows the overall length A of the device, the length B of the prongs, the width C of the prongs, and the width D between the prongs […] In general, it is desirable that the width B only be slightly greater than the diameter of the tube. In addition, it is desirable that the width C of the prongs be wide enough so as to assist in advancing the sponge and doing so without piercing the sponge material. However, it is also desirable that the width C of the prongs not be so great as to interfere with the ability of sliding the device under the plate and strap) curve upward from the fork portion of the [lower] fork extension such that a vertical distance from a plane extends from an outer surface of a base of the fork portion of the [lower] fork extension to the blunt ends of first and second [lower] prongs (Column 2, lines 26-34, On the distal end of the shoulder, extending away or distally from that distal end of the shoulder, and curving in an upward direction relative to the shoulder, are two prongs. Each prong has an inner and an outer edge. The prongs are parallel to one another and generally form a "U"-shape. Most trach tubes have a certain diameter and, in the preferred embodiment, the prongs are separated by a distance wider than the distance of the diameter of the trach tube. In this manner the prongs easily fit around the trach tube)
The combination does not explicitly disclose a vertical distance […] is between about 2 inches and about 4 inches. However, based on the various envisioned embodiments described by to accommodate different users (Hanneman, Column 2, lines 35-38, Furthermore, since the device is preferably made of plastic, it can be molded inexpensively and quickly to fit various size and shapes of trach tubes--i.e. a medical professional likely will require a smaller device for a child) and equipment (Li, Paragraph 0024, Objects can also include other medical devices used for performing a medical procedure including, but not limited to, a sponge or bandage, a surgical tube, a piece of artificial tissue for grafting, a transplant organ, and the like), it would have been prima facie obvious to one skilled in the art before the effective filing date to incorporate a range of vertical distance measures including between “about 2 inches and about 4 inches.”
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Li (US 20110230725 A1) in view of Kao (US 20170312150 A1), in view of Hanneman (US 7093598 B1), in view of Thrasher (US 20190365401 A1), further in view of Berkowitz (US 2698483 A).
Regarding Claim 10, Li in view of Kao, Hanneman, and Thrasher discloses all of the limitations of Claim 8. Li discloses the first and second lower prongs converge toward the respective first and second upper prongs when the upper and lower fork extensions are in the closed position (Paragraph 0043, The engaging end 102a of the first elongated member 110 and the engaging end 102b of the second elongated member 120 operate in conjunction to provide a working end 102. The handle end 104a of the first elongated member 110 and the handle end 104b of the second elongated member 120 operate in conjunction to provide a handle 104. As described below, a technician manipulates handle 104 which, due to the pivotable connection in the first and second elongated members 110, 120, operates to move the working end 102 between an open or unengaged state and a closed or engaged state. The engaging ends 102a, 102b are configured to operably engage with each other to hold an object) and curvature of the prongs (Paragraph 0053, Other configurations of shape and/or curvature are possible for engaging ends 610a, 620a in light of the disclosure herein), but does not depict the inner and outer radii of curvature of the prongs.
Thrasher describes the outer radii curvature of first and second upper and lower prongs (Paragraph 0043, In at least one preferred aspect of the present disclosure, pincers 26A, 26B, 28A, 28B can be angled in an upwardly or downwardly direction out of planarity with the tool body of the forceps 10), (Paragraph 0036, FIGS. 9-10 provide perspective views of in-use illustrations for the forceps 10. As discussed above, the pincers 26A, 26B, 28A, 28B have an arcuate shape bending generally outwardly from planarity with the body of the forceps 10. The bend angle can be anywhere from 15-60 degrees, and preferably 30-45 degrees relative to the handles 22, 24 as illustrated pictorially in FIGS. 9-10)
This structure is further clarified by Berkowitz, wherein the outer radii of curvature of [first and second] upper prongs (Column 2, lines 9-15, Lever arm 10 is provided with an offset curved jaw arm 15 having an inner facing 16 terminating in a gripping surface 17. Gripping surface 17 is concavely curved along both axes and is sufficiently narrow to fit an interproximal spacing of the front and anterior teeth on one of the surfaces thereof) are greater than the outer radii of curvature of [first and second] lower prongs (Figure 2, Column 2, lines 24-33, At the end of jaw arm 22 is a jaw segment 23 having a gripping surface 24 which is oppositely curved along both axes relative to the gripping surface 17 and corresponds thereto in size so that both gripping surfaces 17 and 24 extend from the incisal tip to the gingival edge of the front or anterior teeth […] The jaw segment 23 is freely movable about the end of jaw arm 22 by means of a pivot 23a penetrating jaw ears 25 and 26 and the end of jaw arm 22 therebetween)
It would have been obvious to one skilled in the art before the effective filing date to modify the curvature of the prongs disclosed by Li to incorporate the different radial dimensions disclosed by Berkowitz, so as to provide different degrees of support and leverage when in use in medical settings (Column 1, lines 30-35, The main feature of the clamp resides in the provision of a pair of hinged jaws, one jaw of which is provided with a self shape-adjusting jaw segment to conform to normal variations in the curvature of teeth adjacent interproximal spacings), (Column 2, lines 5-8, The lever arms 10 and 11 are conventional such as are used by physicians and dentists on forceps types of instruments, the spring urge of 13 being limited to pressures suited for the purposes herein).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL Z HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785