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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/13/2025 has been entered.
Claims 1-13, 15-16 and 21-24 remain pending in the present application. Claims 1-2, 7, 9-13, 15-16, and 21-23 have been amended. Claim 14 is newly canceled.
Withdrawn Objections/Rejection
Applicant’s amendments have been acknowledged, and overcome the majority of 112(a) and 112(b) rejections previously set forth in the final office action mailed 7/17/2023. However, some rejections have been maintained (see below).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Chang remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention, with Carter now provided as a secondary reference to more explicitly teach the ruptured state.
Applicant's arguments with respect to the combination with Carter (particularly in regards to claims 10-16 and 21-24) have been fully considered but they are not persuasive.
Applicant argues the combination does not teach a rigid tube and instead teaches a spike. However, said groove defines a flow path (Col. 3, lines 19-22) for tubings 14 and 28, thus the spike is a tubular object with an internal flow path, which would comprise a tube.
Applicant also argues Carter does not address the same problem as Applicant. However, the problem of preventing splattering and safeguarding medical personnel from fluid and/or air that may unintentionally escape is hyper-specific, and would not be the sole principles governing the device function.
Further, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the prior art does not need to be directed towards the exact intentions of Applicant’s invention in order to be within the relevant field of endeavor, or to address particular problems met by certain elements of Applicant’s inventions. In focusing specifically on the membrane of the prior art and the instant invention, one of ordinary skill in the art would appreciate the relevance within the general art of fluid control valves/membranes, not just those for the purpose of preventing splattering.
Applicant’s arguments regarding the remaining claims on at least the same grounds above are similarly found not persuasive.
Claim Objections
Claim 9 objected to because of the following informalities:
Lines 2-3 of claim 9 recite “when said rigid tube disposed through…” appears to be missing the word –is--.
Appropriate correction is required.
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 1-24 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 a membrane as being “in a ruptured state”, but also being “fluid impermeable”. It is unclear how the membrane would be fluid impermeable in the ruptured. In an effort to promote compact prosecution, the membrane is interpreted as impermeable in the sealed state.
Claims 10, and 21 positively recites a foreign object/secondary tube disposed through the membrane. However, as best understood (particularly in light of the specification) the foreign objection/secondary tube appears to be distinct to said chest evacuation tube. As such, the foreign object/secondary tube appears outside the scope of the disclosed chest evacuation tube.
Claim 24 recites the membrane is configured to be ruptured by said secondary tube after said chest evacuation tube. However, Claim 21 recites the membrane as already being pierced by the secondary tube. Thus, it is unclear if the limitations are intended as functional, or if is product-by-process. Thus, the metes and bounds of the claim cannot be determined.
In an effort to promote compact prosecution, this limitation is interpreted as denoting how the tube is intended to be initially pierced by the secondary tube.
The dependent claims are rejected via their respective dependency to independent claims 1, 10 and 21.
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) 1-13, 15-16, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 7,726,305 B2) in view of Carter et al. (US 4,056,116 A),
Regarding claim 1, Chang teaches a chest evacuation tube (Fig. 1, primarily conduit 104 and valve 106; Abstract describes how the chest tube is used to increase expiratory flow from lungs) comprising:
an inlet port (see annotated Fig. 14 below) ;
an outlet port (see annotated Fig. 14 below);
a single flexible hollow tube defining (Fig. 1 shows single tube 104; Figs. 6-8 also show how the tube is flexible) a passageway between said inlet port and said outlet port (passageway, inlet, and outlet are inherent to the tube enabling flow; i.e. oxygen side and lung/target side); and
a fluid impermeable membrane (Figs. 12a and 12b, valve 1200 forms the membrane; Figs. 13a and 13b, collar 1302 valve 1304; and Fig. 14, flap valve 1404; Col. 15, lines 6-25 describe the flow restrictor blocking air, and thus would be fluid/air impermeable when closed) in an open state (Figs. 12a and 14 show the membrane in an open state; Col. 15, line 38 - Col. 16, line 48 also describe how the valves have an open state), said membrane fixable attached to said single flexible hollow tube (Figs. 12a and 12b, show valve 1200 inside a tube; also Figs. 13a and 13b, collar 1302 valve 1304 and Fig. 14, flap valve 1404 are all in their respective tubes),
said membrane interposed between said inlet port and said outlet port or at said outlet port (Col. 15, lines 33-37 describe how the membrane may be positioned anywhere in the system such as within conduit/tube 104),
said passageway is configured to be sealed via said membrane when in a sealed state, and when not in said open state (Col. 15, lines 6-25 describe the valves/flow restrictor block flow through).
PNG
media_image1.png
562
542
media_image1.png
Greyscale
Chang does not explicitly disclose the membrane being in a ruptured state.
In addressing the same problem as Applicant, the problem being the rupture of membranes within sealed tubes for medical use, Carter teaches a sterile tube assembly (entirety of Figs. 2-4; Abstract; also see annotated Figs. below) comprising a rupturable membrane (diaphragm 32) in a ruptured state (specifically Figs. 3 and 4) with a foreign object disposed through said membrane (spike 22; Col. 3, lines 5-32).
PNG
media_image2.png
523
603
media_image2.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the generic manual control means of Chang with the foreign object of Carter since these structures perform the same function of opening/rupturing a valve or seal within a tube. Simply substituting one manual control means for another with predictably allow for the same valve/membrane seal control. See MPEP 2143. Doing so would thus comprise the fluid impermeable membrane having a ruptured state (as shown in Figs. 3-4 of Carter).
Further, limitations of the inlet port being adapted to intake fluid from a human chest cavity, the outlet port adapted to expel said fluid, the single flexible hollow tube adapted to transport fluid from said input port to said output port; and the passageway is sealed via said membrane when not in said ruptured state, when not in said ruptured state said passageway is configured to prevent said fluid from exiting said outlet port, said fluid cannot rupture said membrane, are considered functional language.
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses all the structure as claimed. As such, Chang appears to meet the functions as claimed.
Regarding claim 2, Chang further teaches a manually controlled flap valve (Fig. 14, flap 1404; Col. 16, lines 1-2; also see Figs. 13a and 13b, collar 1302 and valve 1304; Col. 15, lines 46-60).
The limitations of wherein the single flexible hollow tube is configured to be compressed where said membrane that is in said ruptured state is attached is considered functional language.
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses a membrane as claimed, and thus would be configured to rupture when the single flexible hollow tube is squeezed where said fluid membrane is attached.
Regarding claim 3, Chang further teaches the membrane possessing at least one failure line along which said membrane is configured to fail (interface between the collar and bladder as noted in annotated Fig. 14 below, the edges of the bladder separate from the collar allowing fluid therethrough; also see Figs. 13a and 13b which shows duckbill flaps 1304 having a central failure line; Col. 15, lines 46-60).
Further, limitations of the membrane configured to fail where said single flexible hollow tube is compressed is interpreted as function language.
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses a membrane and failure line as claimed, and thus would be configured to fail when compressed in the manner as claimed.
PNG
media_image1.png
562
542
media_image1.png
Greyscale
Regarding claim 4, Chang further teaches the membrane comprising a collar that conforms to an inner cross-sectional shape of the passageway, and a rupturable bladder that stretches to at least an inside periphery of said collar (see annotated Fig. 14 above; see Col. 15, line 61 - Col. 16, line 2; also see Figs. 13a and 13b, 1302 shows the collar conforming to an inner cross-sectional shape and 1304 shows the bladder stretching across; Col. 15, lines 46-60). Further, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses the membrane as claimed, and thus the bladder would be rupturable as claimed.
Regarding claim 5, Chang further teaches the collar having an outer edge that attached to said passageway (annotated Fig. 14 above shows the collar extending to and attached to the edges of passageway 1402; also see Figs. 13a and 13b which show collar 1302 attached to the passageway; described in Col. 15, lines 46-60).
Regarding claim 6, the combination of Chang and Carter does not explicitly teach the rupturable bladder covering the outlet port.
However, Chang does teach that the impermeable membrane may be positioned anywhere in the system such as within conduit/tube 104 (Col. 15, lines 33-37; Col. 16, lines 6-8 also describe how the valve should be easily positionable). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have rearranged the position of the rupturable membrane to cover the outlet port, since this claimed positioning of the membrane does not change its function in blocking flow through the tube. Since Applicant has not given any criticality to why the position of the rupturable bladder being on the outlet port has any importance to the function of the claimed device (Paragraph 19 of Applicant’s specification indicate the bladder “just as easily” be covering the outlet port as opposed to being inside the chest tube), the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144.04(VI)(C) which relates to Rearrangement of Parts. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 7, as previously stated, Carter teaches a sterile tube assembly (entirety of Figs. 2-4; Abstract; also see annotated Figs. below) comprising a rupturable membrane (diaphragm 32) in a ruptured state (specifically Figs. 3 and 4) with a foreign object disposed through said membrane (spike 22; Col. 3, lines 5-32).
PNG
media_image2.png
523
603
media_image2.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the generic manual control means of Chang with the foreign object of Carter since these structures perform the same function of opening/rupturing a valve or seal within a tube. Simply substituting one manual control means for another with predictably allow for the same valve/membrane seal control. See MPEP 2143. Doing so would thus comprise a foreign object disposed through said membrane when the membrane is in a ruptured or opens state (as shown in Figs. 3-4 of Carter).
Further, the limitations of the membrane being configured to be in a ruptured state via a foreign object disposed through said membrane is interpreted as functional language.
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses the membrane and foreign object as claimed, and thus would be capable of being used such that the foreign object is disposed through the impermeable membrane as claimed.
Regarding claim 8, the combination of Chang and Carter substantially discloses the invention of claim 7. The combination further teaches the foreign object is a rigid tube (spike 22 of Carter) that is fixedly retained in said passageway, said rigid tube extending from said outlet port (sealing portion 46, flanges 36, or other portions would serve to retain the rigid tube; see Col. 3, lines 42-65), said rigid tube extending from said outlet port (by nature of also being tube shaped and being concentrically within the outer evacuation tube, the rigid tube of Carter would extend from the outlet port).
Further, the limitations of the membrane being in a ruptured state with a rigid tube fixedly retained in said passageway extending from said outlet port is interpreted as functional language (as it stems from the functional language of claim 7).
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses the membrane and rigid tube as claimed, and thus would be capable of being used such that the rigid tube is fixedly retained in said passageway, said rigid tube extending from said outlet port.
Regarding claim 9, the combination further teaches the membrane comprising stress concentration lines, said impermeable membrane adapted to fail along said stress concentration lines (see Chang, interface between the collar and bladder as noted in annotated Fig. 14 above, the edges of the bladder separate from the collar allowing fluid therethrough; also see Figs. 13a and 13b which shows duckbill flaps 1304 having a central concentration line; Col. 15, lines 46-60).
Further, the limitations of the membrane being configured to break along stress concentration lines when said rigid tube is disposed through said membrane is interpreted as functional language
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses the membrane and rigid tube as claimed, and thus would be capable of being used such that the membrane is configured to break along stress concentration lines when said rigid tube is disposed through the membrane.
Regarding claim 10, Chang teaches a chest evacuation tube (Fig. 1, primarily conduit 104 and valve 106; Abstract describes how the chest tube is used to increase expiratory flow from lungs) comprising:
an inlet port (see annotated Fig. 14 below) ;
an outlet port (see annotated Fig. 14 below);
a passageway defined between said inlet port and said outlet port (Fig. 1 shows single tube 104; Figs. 6-8 also show how the tube is flexible); and
a membrane in an open state (Figs. 12a and 14 show the membrane in an open state; Col. 15, line 38 - Col. 16, line 48 also describe how the valves have an open state),
said membrane, configured to be impermeable to said body fluid when not in said open state (Figs. 12a and 12b, valve 1200; Figs. 13a and 13b, collar 1302 valve 1304; and Fig. 14, flap valve 1404; Col. 15, lines 6-25 describe the flow), said membrane fixedly attached to said evacuation tube in said passageway (Figs. 12a and 12b, valve 1200; Figs. 13a and 13b, collar 1302 and valve 1304; and Fig. 14, flap valve 1404; Col. 15, lines 6-25 describe the flow restrictor blocking air, and thus would be fluid impermeable),
restrictor blocking air, and thus would be fluid/air impermeable when closed).
PNG
media_image1.png
562
542
media_image1.png
Greyscale
Chang does not explicitly disclose the membrane being in a ruptured state and a rigid tube extending through the ruptured membrane, said rigid tube having an exit port extending beyond said outlet port, said exit port in communication with said inlet port.
In addressing the same problem as Applicant, the problem being the rupture of membranes within sealed tubes for medical use, Carter teaches a sterile tube assembly (entirety of Figs. 2-4; Abstract; also see annotated Figs. below) comprising a rupturable membrane (diaphragm 32) in a ruptured state (specifically Figs. 3 and 4) with a rigid tube disposed through said membrane (spike 22; Col. 3, lines 5-32), said rigid tube having an exit port that extends from said chest evacuation tube beyond said outlet port, said exit port in communication with said inlet port (Fig. 4 in particular shows how the end of spike 24 extends out of tube 28; also see annotated Figs. below).
PNG
media_image2.png
523
603
media_image2.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the generic manual control means of Chang with the foreign object of Carter since these structures perform the same function of opening/rupturing a valve or seal within a tube. Simply substituting one manual control means for another with predictably allow for the same valve/membrane seal control. See MPEP 2143. Doing so would thus comprise a rigid tube extending through the ruptured membrane, said rigid tube having an exit port that extends from said chest tube beyond said outlet port, said exit port in communication with said inlet port (as shown in Figs. 3-4 of Carter and as annotated above).
The limitations of the inlet port adapted to intake bodily fluid from a human chest cavity into a chest evacuation tube; the outlet port adapted to expel said bodily fluid out of said single use chest evacuation tube is considered functional language.
Further, the membrane being in a ruptured state with a rigid tube disposed through, the rigid tube exit port extending from the chest tube beyond the outlet of said chest tube, said exit port being in fluid communication with the inlet port of the chest tube is interpreted as functional language.
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses the membrane, rigid tube, and ports as claimed, and thus would be capable of being used in the manner as claimed.
Regarding claim 11, the combination further teaches the membrane comprising a collar that conforms to an inner cross-sectional shape of the passageway, and a bladder that stretches to at least an inside periphery of said collar (see Chang annotated Fig. 14 below; see Col. 15, line 61 - Col. 16, line 2; also see Figs. 13a and 13b, 1302 shows the collar conforming to an inner cross-sectional shape and 1304 shows the bladder stretching across; Col. 15, lines 46-60).
Regarding claim 12, the combination of Chang and Carter substantially disclose the invention of claim 11. The combination does not explicitly teach the rupturable bladder covering the outlet port and the collar attaches within 2 inches of said outlet port.
However, Chang does teach that the impermeable membrane may be positioned anywhere in the system such as within conduit/tube 104 (Col. 15, lines 33-37; Col. 16, lines 6-8 also describe how the valve should be easily positionable). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have rearranged the position of the rupturable membrane be disposed within 2 inches of said outlet port, since this claimed positioning of the membrane does not change its function in blocking flow through the tube. Since Applicant has not given any criticality to why the position of the rupturable bladder being on the outlet port has any importance to the function of the claimed device (Paragraphs 18-19 of Applicant’s specification indicate the bladder is disposed two inches from the outlet in “certain embodiments, and further that the bladder “just as easily” may be covering the outlet port as opposed to being inside the chest tube), the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144.04(VI)(C) which relates to Rearrangement of Parts. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 13, the combination further teaches the membrane possessing at least one failure line that extends across said bladder (see Chang, interface between the collar and bladder as noted in annotated Fig. 14 above, the edges of the bladder separate from the collar allowing fluid therethrough, the edges extending at least from one side to the other side of said bladder, and thus interpreted as extending across said bladder; also see Figs. 13a and 13b which shows duckbill flaps 1304 having a central failure line extending straight across the membrane; Col. 15, lines 46-60).
Regarding claim 15, the combination of Chang and Carter substantially discloses the invention of claim 13.
The limitations of wherein the single flexible hollow tube is compressed where said membrane that is in said ruptured state in said passageway is considered functional language (as it appears to recite a method step in how the invention is used).
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses a membrane as claimed, and thus would be configured to rupture when the tube is compressed where said fluid membrane is attached.
Regarding claim 16, the combination of Chang and Carter substantially discloses the invention of claim 10.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Examiner notes since there was no evidence provided by the Applicant that the process of rupturing the membrane by the rigid tube imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation of being “configured to be in said ruptured state by way of said rigid tube penetrating said membrane” is being given very little patentable weight. In the instant case, the product of the breaking process appears to be the ruptured membrane, and thus would appear taught by Chang and Carter. Also see MPEP 2113.
Regarding claim 21, Chang teaches a chest evacuation tube (Fig. 1, primarily conduit 104 and valve 106; Abstract describes how the chest tube is used to increase expiratory flow from lungs) comprising:
a single passageway that extends from an inlet port to an outlet port (see annotated Fig. 14 below for example; Fig. 1 also shows single tube 104; Figs. 6-8 also show how the tube is flexible; inlet and outlet are inherent to the tube being for fluid transport);
said passageway configured to intake air from a human body into said chest evacuation tube from a human chest cavity via said inlet port (Abstract, Col. 1, lines 13-16 and Col. 15, lines 1-24 describe how the tube is used);
a membrane in a ruptured state (Figs. 12a and 14 show the membrane in an open i.e. ruptured state; Col. 15, line 38 - Col. 16, line 48 also describe how the valves have an open state),
wherein said membrane would otherwise block said passage from fluid (Figs. 12a and 12b, valve 1200; Figs. 13a and 13b, collar 1302 valve 1304; and Fig. 14, flap valve 1404; Col. 15, lines 6-25 describe the flow), said membrane fixedly attached to said tube in said passageway(Figs. 12a and 12b, valve 1200; Figs. 13a and 13b, collar 1302 and valve 1304; and Fig. 14, flap 1404; Col. 15, lines 6-25 describe the flow restrictor blocking air, and thus would be fluid impermeable),
restrictor blocking air, and thus would be fluid/air impermeable when closed).
PNG
media_image1.png
562
542
media_image1.png
Greyscale
Chang does not explicitly disclose a secondary tube extending through the outlet port, the secondary tube penetrates through said membrane, said secondary tube having an exit port that extends outside of said chest evacuation tube, said exit port in communication with said inlet port.
In addressing the same problem as Applicant, the problem being the rupture of membranes within sealed tubes for medical use, Carter teaches a sterile tube assembly (entirety of Figs. 2-4; Abstract; also see annotated Figs. below) comprising a rupturable membrane (diaphragm 32) with a rigid tube disposed through said membrane that would otherwise block said passage from said fluid (spike 22; Col. 3, lines 5-32), said rigid tube having an exit port that extends from said chest evacuation tube beyond said outlet port, said exit port in communication with said inlet port (Fig. 4 in particular shows how the end of spike 24 extends out of tube 28; also see annotated Figs. below).
PNG
media_image2.png
523
603
media_image2.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the generic manual control means of Chang with the foreign object of Carter since these structures perform the same function of opening/rupturing a valve or seal within a tube. Simply substituting one manual control means for another with predictably allow for the same valve/membrane seal control. See MPEP 2143. Doing so would thus comprise a rigid tube extending through the ruptured membrane, said rigid tube having an exit port that extends from said chest tube beyond said outlet port, said exit port in communication with said inlet port (as shown in Figs. 3-4 of Carter and as annotated above).
The limitations of the passageway being configured to intake bodily fluid from a human body into said chest tube from a human chest cavity via said inlet port; the outlet port adapted to expel said bodily fluid out of said single use chest evacuation tube is considered functional language.
Further, limitations of the secondary tube extending through said outlet port, said secondary tube penetrates through a membrane that would otherwise block said passageway from said fluid, the exit port of the secondary tube extending outside of said chest evacuation tube, said exit port in communication with the inlet port of the passageway is interpreted as functional language (as it appears to recite a method step in how the invention is used).
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses the membrane, secondary tube, and ports as claimed, and thus would be capable of being used in the manner as claimed.
Regarding claim 22, the combination of Chang and Carter substantially discloses the invention of claim 21.
Limitations of the membrane is configured to be ruptured by said secondary tube are considered functional language.
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses a membrane and secondary tube as claimed as claimed, and thus would be configured to be ruptured by said secondary tube.
Regarding claim 23, the combination of Chang and Carter substantially discloses the invention of claim 21. The combination further teaches a portion of said membrane is displaced but unharmed by said secondary tube (Fig. 14 best shows bladder 1404 opening like a hinged door, and thus remaining intact when in a ruptured state; Figs. 13a and 13b show a linear failure stripe in the middle of membrane 1304; Col.15, lines 46-60 describe how the flaps 1304 separate from one another at the central line, thus the two ends of the bladder would remain intact).
Further, limitations of the membrane is configured to be displaced but unharmed by the secondary tube is considered functional language.
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended function as recited the claim, then it meets the claim. In the instant case, the device of Chang and Carter discloses a membrane and secondary tube as claimed as claimed, and thus the membrane would be configured as claimed.
Regarding claim 24, the combination of Chang and Carter substantially discloses the invention of claim 21.
"[E]ven though product-by-process claims are limited by and defined by the process,
determination of patentability is based on the product itself. The patentability of a product
does not depend on its method of production. If the product in the product-by-process claim is
the same as or obvious from a product of the prior art, the claim is unpatentable even though
the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ
964, 966 (Fed. Cir. 1985). Examiner notes since there was no evidence provided by the
Applicant that the process of rupturing the membrane by the secondary tube imparts a
structural difference onto the end product of the claimed invention that is not present in the
prior art, the limitation of “said membrane is configured to be ruptured by said secondary tube
after said chest evacuation tube has been inserted in said chest tube cavity” is being given very
little patentable weight. In the instant case, the product of the breaking process appears to be
the ruptured membrane, and thus would appear taught by Chang and Carter. Also see MPEP
2113.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mantell (US 2008/0033344 A1) appears to teach a chest evacuation tube having an impermeable membrane that anticipate claim 10 of the instant application (Fig. 1, element 20).
Kolf et al. (US 5,1585,39 A) appears to teach an evacuation tube having an impermeable membrane that anticipates claim 10 of the instant application (Fig. 4, elements 41 and 42).
Gayton et al. (US 2009/0014021 A1) discloses a tubular transfer device having a series of impermeable membranes having failure lines (Fig. 11, element 21).
May et al. (US 2009/0196675 A1) discloses a tubular transfer device having an impermeable and rupturable membrane (Fig. 4, element 66; Fig. 9, and Fig. 20).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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, Rebecca E Eisenberg can be reached at (571) 270-5879. 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.
/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781