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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 04/23/2026 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected system, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/23/2026.
Claim Objections
Claims 8 and 16 are objected to because of the following informalities:
Regarding claim 8, the phrase “the self-inflating cuff comprise a” in lines 1-2 should read “the self-inflating cuff comprises a” for proper grammar,
Regarding claim 9, the phrase “the first membrane layer and the second membrane layers” in line 10 to read “the first membrane layer and the second membrane layer
Regarding claim 16, the phrase “the self-inflating cuff comprise a” in line 1 should read “the self-inflating cuff comprises a” for proper grammar,
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 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase “a self-inflating cuff” in line 7 renders the claim indefinite because it is unclear. It is unclear whether this is a different cuff or the aforementioned cuff in line 1 of claim 1. Examiner is interpreting it as the latter.
Regarding claims 2-8, these claims are rejected due to their dependency upon a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-4, 6 9, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Baron (U.S Patent No. 4379453) in view of Jaszai (U.S Patent No. 5826723).
Regarding claim 1, Baron discloses the limitations (Claim 1) A self-inflating cuff (102 in Fig. 7), comprising:
an exterior surface (exterior surface of 106 in Fig. 5 and 7, see Col.7, lines 20-33 – the exterior surface of cuff 102 is formed by the exterior surface of outer wall 106);
and an interior surface (interior surface of 104 and 106 in Fig. 5 and 7, see Col.7, lines 20-33 – the interior surface of cuff 102 is formed by the interior surface of walls 104 and 106 that form envelope 116) including:
a first layer (left-hand side of capsule 46 in Fig. 4) formed within and along the interior surface (interior surface of 104 and 106) at a first position (see Fig. 4 and Fig. 7, annotated Baron drawing 1 below, and Col.7, lines 8-17 – gas generating means such as gas capsule 46 in Fig. 4 may be formed within the envelope 116 formed by interior surface of walls 104 and 106 and along the interior surface of said walls, the left-hand side of capsule 46 annotated below is at a first position relative to the right-hand side of capsule 46), wherein the first layer forms a first compartment that is configured to house a first substance (52 in Fig. 4) and to rupture in response to a force applied to the exterior surface (exterior surface of 106) of a self-inflating cuff (102, see annotated Baron drawing 1 below, Fig. 4, and Col. 4, lines 61-67- Col.5, lines 1-3, and Col.5, lines 27-31 – left-hand side of capsule 46 forms a first compartment housing liquid chemical 52 and is configured to rupture in response to a force applied to the exterior surface of wall 106), and
a second layer (right-hand side of capsule 46 in Fig. 4) formed within and along the interior surface (interior surface of 104 and 106) at a second position (see Fig. 4 and Fig. 7, annotated Baron drawing 1 below, and Col.7, lines 8-17 – gas generating means such as gas capsule 46 in Fig. 4 may be formed within the envelope 116 formed by interior surface of walls 104 and 106 and along the interior surface of said walls, the right-hand side of capsule 46 annotated below is at a second position relative to the left-hand side of capsule 46), wherein the second layer forms a second compartment, separate from the first compartment, that is configured to house a second substance (50 in Fig. 4) in isolation from the first substance (52 in Fig. 4) and to rupture in response to the force applied to the exterior surface (exterior surface of 102) of the self-inflating cuff (102, see annotated Baron drawing 1 below, Fig. 4, and Col. 4, lines 61-67- Col.5, lines 1-3, and Col.5, lines 27-31 – right-hand side of capsule 46 forms a second, separate and isolated compartment housing powdered chemical 50 and is configured to rupture in response to a force applied to the exterior surface of wall 106);
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wherein the self-inflating cuff (102) is configured to, when the first and second compartments rupture in response to the force applied to the exterior surface (exterior surface of 102), cause the first (52) and second (50) substances to combine to initiate a chemical reaction to produce a reactionary force on the interior surface (interior surface of 104 and 106) of the self-inflating cuff (102) that causes the self-inflating cuff (102) to expand (see Fig. 5-6 and Col.7, lines 48-53 – when capsule 46 ruptures, substances 50 and 52 mix and react to form a gas that produces a force on interior surfaces of walls 104 and 106 to expand the envelope 116 formed therein and thus expand the cuff 102); and
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wherein the self-inflating cuff (102) is further configured to expand such that a first opening at a first end of the self-inflating cuff (102) and a second opening at a second end opposite the first end of the self-inflating cuff (102) enlarge enough to receive a container (100 in Fig. 7) through the first opening and a tubing (132 in Fig. 6) of the container (100) through the second opening (see annotated Baron drawing 2 below and Fig. 5-6– the annotated first opening and second opening of the cuff 102 are configured to expand at least at their outer diameters as the outer wall 106 expands as seen between Fig. 5 and 6 with the outer wall 106 expanding, examiner notes that the first and second openings are configured to receive the container 100 and tubing 136 as seen in Fig. 5-7).
While Baron discloses a gas-generating capsule having a first layer forming the first compartment and a second layer forming the second compartment, Baron fails to explicitly disclose the first and second layers as membranes. Examiner notes the term “membrane” is being interpreted under BRI as a thin, flexible material or selective barrier.
Jaszai discloses an impact resistance wrapping system (see Fig. 15-16) that utilizes a rupturable, gas-generating capsule (7 in Fig. 15-16), wherein the capsule (7) is formed from a shell (71 in Fig. 16) formed from a synthetic resin material having fine pores allowing gases to pass therethrough and that separated into two compartments by membrane (72 in Fig. 16, see Col.6, lines 37-57). Thus, Jaszai teaches two separate, isolated compartments of a capsule (7) each formed by a membrane layer consisting of the selectively permeable shell (71).
Since Baron discloses a rupturable, gas-generating capsule having two separate, isolated compartments, and Jaszai discloses a similar rupturable, gas-generating capsule having two separate, isolated compartments, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas-generating capsule taught by Baron to incorporate the selectively permeable shell of Jaszai such that the first and second layers are membrane layers. Jaszai teaches that the selectively permeable shell of the gas-generating capsule allows gas to pass therethrough but prevents liquid components from leaking out of the shell (see Col.6, lines 53-57).
Regarding claim 3, modified Baron discloses the cuff of claim 1, as discussed above. In modified Baron, Baron discloses (Claim 3) wherein the first compartment is adjacent to the second compartment within the self-inflating cuff (102, see Fig. 4 and annotated Baron drawing 1 above – the first compartment housing substance 52 is adjacent second compartment housing substance 50 in capsule 46).
Regarding claim 4, modified Baron discloses the cuff of claim 1, as discussed above. In modified Baron, Baron discloses (Claim 4) wherein the force applied to the exterior surface (exterior surface of 106) of the self-inflating cuff (102) is a compression force applied to the first and second ends of the self-inflating cuff (102, see annotated Baron drawing 2 above for ends, see Col.2, lines 39-43 – outer wall 106 may be grasped and squeezed by the user over the capsule 46 to rupture it, examiner notes the force being applied to the exterior surface of the cuff is a functional limitation of the cuff and thus the compression of the capsule 46 is capable of being configured to be applied on the first and second ends until the capsule 46 is ruptured).
Regarding claim 6, modified Baron discloses the cuff of claim 1, as discussed above.
In modified Baron, Baron discloses (Claim 6) wherein the first compartment is configured to rupture before the second compartment when the force is applied to the exterior surface (exterior surface of 106) of the self-inflating cuff (102, see annotated Baron drawing 1 above for compartments and Col.2, lines 39-43 – outer wall 106 may be grasped and squeeze by the user to rupture capsule 46 and thus the first compartment of capsule 46 is capable of rupturing first when said force is applied as there is no structure of the capsule 46 that would prevent this function from occurring).
Regarding claim 9, Baron discloses the limitations (Claim 9) A self-inflating cuff (102 in Fig. 7), comprising:
providing a self-inflating cuff (102) having an exterior surface (exterior surface of 106 in Fig. 5 and 7) and an interior surface (interior surface of 104 and 106 in Fig. 5 and 7, see Col.7, lines 20-33 – the interior surface of cuff 102 is formed by the interior surface of walls 104 and 106 that form envelope 116) and including a first layer (left-hand side of capsule 46 in Fig. 4) formed within and along the interior surface (interior surface of 104 and 106) at a first position (see Fig. 4 and Fig. 7, annotated Baron drawing 1 above, and Col.7, lines 8-17 – gas generating means such as gas capsule 46 in Fig. 4 may be formed within the envelope 116 formed by interior surface of walls 104 and 106 and along the interior surface of said walls, the left-hand side of capsule 46 annotated below is at a first position relative to the right-hand side of capsule 46), wherein the first layer forms a first compartment that is configured to house a first substance (52 in Fig. 4, see annotated Baron drawing 1 above, and Col. 4, lines 61-67- Col.5, lines 1-3, and Col.5, lines 27-31 – left-hand side of capsule 46 forms a first compartment housing liquid chemical 52), and a second layer (right-hand side of capsule 46 in Fig. 4) formed within and along the interior surface (interior surface of 104 and 106) at a second position (see Fig. 4 and Fig. 7, annotated Baron drawing 1 above, and Col.7, lines 8-17 – gas generating means such as gas capsule 46 in Fig. 4 may be formed within the envelope 116 formed by interior surface of walls 104 and 106 and along the interior surface of said walls, the right-hand side of capsule 46 annotated below is at a second position relative to the left-hand side of capsule 46), wherein the second layer forms a second compartment, separate from the first compartment, that is configured to house a second substance (50 in Fig. 4) in isolation from the first substance (52 in Fig. 4, see annotated Baron drawing 1 above, and Col. 4, lines 61-67- Col.5, lines 1-3, and Col.5, lines 27-31 – right-hand side of capsule 46 forms a second, separate and isolated compartment housing powdered chemical 50);
applying a force to the exterior surface (exterior surface of 106) of the self-inflating cuff (102, see Col.7, lines 48-53), wherein the force causes the first layer (left-hand side of capsule 46) and the second layer (right-hand side of capsule 46) to rupture allowing the first (52) and second (50) substances to combine initialing a chemical reaction based on a combination of the first (52) and second (50) substances to produce a reactionary force on the interior surface (interior surface of 104 and 106) of the self-inflating cuff (102) that causes the self-inflating cuff (102) to expand such that a first opening at a first end of the self-inflating cuff (102) and a second opening at a second end opposite the first end of the self-inflating cuff (102) enlarge enough to receive a container (100 in Fig. 7) through the first opening and a tubing (132 in Fig. 6) of the container (100) through the second opening (see annotated Baron drawing 2 above, see Fig. 5-6 and Col.7, lines 48-53 – when capsule 46 ruptures, substances 50 and 52 mix and react to form a gas that produces a force on interior surfaces of walls 104 and 106 to expand the envelope 116 formed therein and thus expand the cuff 102, the annotated first opening and second opening of the cuff 102 are configured to expand at least at their outer diameters as the outer wall 106 expands as seen between Fig. 5 and 6 with the outer wall 106 expanding, examiner notes that the first and second openings are configured to receive the container 100 and tubing 136 as seen in Fig. 5-7); and
receiving the container (100) and the tubing (136) of the container (100) via the first and second ends of the self-inflating cuff (102, see annotated Baron drawing 1 above for ends, examiner notes there is no claimed order to the steps of applying the force to the exterior surface of the cuff or receiving the container and tubing in the cuff and thus the cuff 102 does receive the container 100 and tubing 136 therewithin its first and second ends).
While Baron discloses a gas-generating capsule having a first layer forming the first compartment and a second layer forming the second compartment, Baron fails to explicitly disclose the first and second layers as membranes. Examiner notes the term “membrane” is being interpreted under BRI as a thin, flexible material or selective barrier.
Jaszai discloses an impact resistance wrapping system (see Fig. 15-16) that utilizes a rupturable, gas-generating capsule (7 in Fig. 15-16), wherein the capsule (7) is formed from a shell (71 in Fig. 16) formed from a synthetic resin material having fine pores allowing gases to pass therethrough and that separated into two compartments by membrane (72 in Fig. 16, see Col.6, lines 37-57). Thus, Jaszai teaches two separate, isolated compartments of a capsule (7) each formed by a membrane layer consisting of the selectively permeable shell (71).
Since Baron discloses a rupturable, gas-generating capsule having two separate, isolated compartments, and Jaszai discloses a similar rupturable, gas-generating capsule having two separate, isolated compartments, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas-generating capsule taught by Baron to incorporate the selectively permeable shell of Jaszai such that the first and second layers are membrane layers. Jaszai teaches that the selectively permeable shell of the gas-generating capsule allows gas to pass therethrough but prevents liquid components from leaking out of the shell (see Col.6, lines 53-57).
Regarding claim 13, modified Baron discloses the method of claim 9, as discussed above. In modified Baron, Baron discloses (Claim 13) wherein the first compartment is adjacent to the second compartment within the self-inflating cuff (102, see Fig. 4 and annotated Baron drawing 1 above – the first compartment housing substance 52 is adjacent second compartment housing substance 50 in capsule 46).
Regarding claim 14, modified Baron discloses the method of claim 9, as discussed above. In modified Baron, Baron discloses (Claim 14) wherein the first compartment is configured to rupture before the second compartment when the force is applied to the exterior surface (exterior surface of 106) of the self-inflating cuff (102, see annotated Baron drawing 1 above for compartments and Col.2, lines 39-43 – outer wall 106 may be grasped and squeeze by the user to rupture capsule 46 and thus the first compartment of capsule 46 is capable of rupturing first when said force is applied as there is no structure of the capsule 46 that would prevent this function from occurring).
Claim(s) 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Baron in view of Jaszai as applied to claim 1 and 9 above, respectively, and further in view of Lane et al (U.S Patent No. 6164492, “Lane”).
Regarding claim 5, modified Baron discloses the cuff of claim 1, as discussed above.
While Baron discloses that a force is applied to the exterior surface (exterior surface of 106) to rupture the capsule (46), Baron discloses this force as a compression force (Col.2, lines 39-43). Thus, modified Baron fails to disclose (Claim 5) wherein the force applied to the exterior surface of the self-inflating cuff is a tension force applied to the first and second ends of the self- inflating cuff.
Lane discloses self-inflating cuff (100 in Fig. 1-2) suitable for applying pressure to a drug container (500 in Fig. 5), wherein the cuff (100) comprises a plurality of rupturable compartments (110, 114, 116, 118 in Fig. 2) that when ruptured initiate a chemical reaction between substances therein to produce a gas (see Col.4, lines 11-27). Lane teaches that the plurality of compartments (110, 114, 116, 118 ) may be ruptured in response to applied tensile force on the dividers (186, 188, 190 in Fig. 2) between the compartments (110, 114, 116, 118, see Col.3, lines 56-65 and Col.6, lines 1-6).
Since modified Baron discloses a self-inflating cuff comprising gas-generating means in the form of a rupturable capsule, and Lane discloses an alternative gas-generating means in the form of a sealed envelope having a divider that is rupturable under tension, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas-generating capsule taught by Baron to be a sealed envelope with two separated, isolated compartments having a frangible divider therebetween as taught by Lane such that the envelope is configured to be ruptured by an application of tensile force to the exterior surface of the cuff. Lane provides that tensile force is an acceptable force application for rupturing a gas-generating means having materials with predetermined elongations (see Col.3, lines 56-65). One of ordinary skill in the art would have recognized that modifying the capsule of Baron to be a sealed envelope like Lane with a frangible divider therewithin would operate in the same manner as Baron to be ruptured to generate gas.
Regarding claim 12, modified Baron discloses the method of claim 9, as discussed above.
While Baron discloses that a force is applied to the exterior surface (exterior surface of 106) to rupture the capsule (46), Baron discloses this force as a compression force (Col.2, lines 39-43). Thus, modified Baron fails to disclose (Claim 12) wherein the force applied to the exterior surface of the self-inflating cuff is a tension force applied to the first and second ends of the self- inflating cuff.
Lane discloses self-inflating cuff (100 in Fig. 1-2) suitable for applying pressure to a drug container (500 in Fig. 5), wherein the cuff (100) comprises a plurality of rupturable compartments (110, 114, 116, 118 in Fig. 2) that when ruptured initiate a chemical reaction between substances therein to produce a gas (see Col.4, lines 11-27). Lane teaches that the plurality of compartments (110, 114, 116, 118 ) may be ruptured in response to applied tensile force on the dividers (186, 188, 190 in Fig. 2) between the compartments (110, 114, 116, 118, see Col.3, lines 56-65 and Col.6, lines 1-6).
Since modified Baron discloses a self-inflating cuff comprising gas-generating means in the form of a rupturable capsule, and Lane discloses an alternative gas-generating means in the form of a sealed envelope having a divider that is rupturable under tension, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas-generating capsule taught by Baron to be a sealed envelope with two separated, isolated compartments having a frangible divider therebetween as taught by Lane such that the envelope is configured to be ruptured by an application of tensile force its two opposite ends. Lane provides that tensile force is an acceptable force application for rupturing a gas-generating means having materials with predetermined elongations (see Col.3, lines 56-65). One of ordinary skill in the art would have recognized that modifying the capsule of Baron to be a sealed envelope like Lane with a frangible divider therewithin would operate in the same manner as Baron to be ruptured to generate gas.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Baron in view of Jaszai as applied to claim 9 above, and further in view of Bras et al. (U.S Patent Pub. No. 20080017530 A1, “Bras”).
Regarding claim 11, modified Baron discloses the method of claim 9, as discussed above. In modified Baron, Baron discloses (Claim 11) wherein the force applied to the exterior surface (exterior surface of 106) of the self-inflating cuff (102) is a compression force applied to the exterior surface (exterior surface of 106, see Col.2, lines 39-43 – exterior surface of outer wall 106 may be grasped and squeezed by the user over the capsule 46 to rupture it indicating that it is a compression force).
However, modified Baron fails to explicitly state the compression force applied to the exterior surface of the first and second ends of the self-inflating cuff.
Bras discloses a two compartment container (110 in Fig. 1-2) having two separate, isolated compartments (111, 112 in Fig. 2) for storing two separate substances with a membrane (100 in Fig. 2) therebetween (see para. 0049). Bras teaches that the membrane (100) separating the compartments may be rupturable upon application of a compression force applied to the first compartment (111) and the second compartment (112) to push them together which would cause the membrane (100) to rupture (see para. 0050).
Since Baron discloses a two compartment capsule, having two isolated compartments separated by a membrane modified by Jaszai to have a gas-permeable outer membrane layer, and Bras discloses that two compartment capsule separated by a membrane can be rupturable under compression applied to its two opposing ends to rupture the membrane for mixing of the substances, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cuff of modified Baron such that a compression force is applied to the opposing ends of the cuff of Baron such that the compression force is transmitted to the opposing ends of the capsule to rupture the membrane of the capsule to initiate the chemical reaction as taught by Bras. Bras provides that the construction of the two-compartment container allows for a predetermined type of rupture based on the user applied force which may be a compressing force pushing the containers together, rotational force, or both (see para. 0050). Examiner notes that these applied forces are known in the art for being used by operators to rupture or break frangible components.
Claim(s) 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Baron in view of Jaszai as applied to claim 1 and 9 above, respectively, and further in view of Bryant et al. (U.S Patent Pub. No. 5738657, “Bryant”).
Regarding claim 7, modified Baron discloses the cuff of claim 1, as discussed above. In modified Baron, Baron discloses the limitations (Claim 7) wherein: the first compartment includes a first predetermined amount of the first substance (52 in Fig. 4) and the second compartment includes a second predetermined amount of the second substance (50 in Fig. 4, see Col. 4, lines 68- Col.5, lines 1-10 – first and second compartments each contain a measured amount of their respective substances).
However, modified Baron fails to explicitly disclose (Claim 7) the first predetermined amount of the first substance and the second predetermined amount of the second substance are based on a volume of the self-inflating cuff.
Bryant discloses a self-inflating cuff (12 in Fig. 2 and 5) for drug delivery comprising two separate compartments (52, 54 in Fig. 5) containing predetermined amounts of reactive substances, wherein Bryant teaches that the predetermined amounts of the reactive substances are chosen to provide the necessary volume of pressurized gas for the cuff (12, see Col.8, lines 18-40).
Since modified Baron discloses a gas-generating capsule for a self-inflating cuff, wherein the capsule is rupturable to mix reactive substances to produce a gas for expanding the cuff, and Bryant discloses a similar gas-generating system for a self-inflating bladder, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas-generating capsule taught by Baron to incorporate predetermined amounts of the reactive substances based on the volume of the cuff as taught by Bryant. Bryant provides that the amount of the reactive substances controls the volume of gas generated and thus they must be predetermined amounts to provide the necessary volume for the volume of the cuff and the desired delivery rate (see Col.8, lines 18-40).
Regarding claim 15, modified Baron discloses the method of claim 9, as discussed above. In modified Baron, Baron discloses the limitations (Claim 15) wherein: the first compartment includes a first predetermined amount of the first substance (52 in Fig. 4) and the second compartment includes a second predetermined amount of the second substance (50 in Fig. 4, see Col. 4, lines 68- Col.5, lines 1-10 – first and second compartments each contain a measured amount of their respective substances).
However, modified Baron fails to explicitly disclose (Claim 15) the first predetermined amount of the first substance and the second predetermined amount of the second substance are based on a volume of the self-inflating cuff.
Bryant discloses a self-inflating cuff (12, 36 in Fig. 2 and 5) for drug delivery comprising two separate compartments (52, 54 in Fig. 5) containing predetermined amounts of reactive substances, wherein Bryant teaches that the predetermined amounts of the reactive substances are chosen to provide the necessary volume of pressurized gas for the cuff (12, see Col.8, lines 18-40).
Since modified Baron discloses a gas-generating capsule for a self-inflating cuff, wherein the capsule is rupturable to mix reactive substances to produce a gas for expanding the cuff, and Bryant discloses a similar gas-generating system for a self-inflating bladder, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the gas-generating capsule taught by Baron to incorporate predetermined amounts of the reactive substances based on the volume of the cuff as taught by Bryant. Bryant provides that the amount of the reactive substances controls the volume of gas generated and thus they must be predetermined amounts to provide the necessary volume for the volume of the cuff and the desired delivery rate (see Col.8, lines 18-40).
Claim(s) 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Baron in view of Jaszai as applied to claim 1 and 9 above, respectively, and further in view of McCullough et al. (U.S Patent Pub. No. 20220072224 A1).
Regarding claim 8, modified Baron discloses the cuff of claim 1, as discussed above.
While Baron discloses that cuff (102) is formed from a soft, bendable plastic material that is configured to expand from gas generation (see Col.4, lines 25-27), wherein the cuff (102) can be deflated by cutting a nipple (42 in Fig. 3) to release the gas (see Col.6, lines 53-58); however modified Baron fails to disclose (Claim 8) wherein the self-inflating cuff comprise a resilient material such that, after the self-inflating cuff expands, the self-inflating cuff self- contracts at a predetermined rate until the self-inflating cuff returns to an unexpanded state.
McCullough discloses a drug delivery container (102 in Fig. 1) with a container body (103 in Fig. 1) constructed from an elastic and/or resilient material such that when the container body (103) is pressurized by fluid it expands and stretches outwardly and then the elasticity of the container body (103) generates a contraction force on the inner volume (104, see para. 0016).
Since Baron discloses an expandable cuff that is pressurized by gas and expands and stretches outwardly, and can be deflated by cutting a nipple to release the gas, and McCullough discloses an expandable container that self-deflates after pressurization due to the elasticity of the resilient material of the container, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cuff material of modified Baron to be a resilient material as taught by McCullough such that upon cutting the nipple of Baron, the cuff would be resilient such that it self-deflates to an unexpanded state. McCullough provides that the container body being constructed from a resilient material allows for expansion upon pressurization and self-contraction from the elasticity rather than requiring external forces to initiate contraction (see para. 0016).
Regarding claim 16, modified Baron discloses the method of claim 9, as discussed above.
While Baron discloses that cuff (102) is formed from a soft, bendable plastic material that is configured to expand from gas generation (see Col.4, lines 25-27), wherein the cuff (102) can be deflated by cutting a nipple (42 in Fig. 3) to release the gas (see Col.6, lines 53-58); however modified Baron fails to disclose (Claim 16) wherein the self-inflating cuff comprise a resilient material such that, after the self-inflating cuff expands, the self-inflating cuff self- contracts at a predetermined rate until the self-inflating cuff returns to an unexpanded state.
McCullough discloses a drug delivery container (102 in Fig. 1) with a container body (103 in Fig. 1) constructed from an elastic and/or resilient material such that when the container body (103) is pressurized by fluid it expands and stretches outwardly and then the elasticity of the container body (103) generates a contraction force on the inner volume (104, see para. 0016).
Since Baron discloses an expandable cuff that is pressurized by gas and expands and stretches outwardly, and can be deflated by cutting a nipple to release the gas, and McCullough discloses an expandable container that self-deflates after pressurization due to the elasticity of the resilient material of the container, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cuff material of modified Baron to be a resilient material as taught by McCullough such that upon cutting the nipple of Baron, the cuff would be resilient such that it self-deflates to an unexpanded state. McCullough provides that the container body being constructed from a resilient material allows for expansion upon pressurization and self-contraction from the elasticity rather than requiring external forces to initiate contraction (see para. 0016).
Allowable Subject Matter
Claims 2 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Baron (U.S Patent No. 4379453), Lane et al. (U.S Patent No. 6164492, “Lane”), Wood et al. (U.S Patent Pub. No. 20080140057 A1, “Wood”), and Bryant et al. (U.S Patent No. 5738657, “Bryant”).
Baron discloses a self-inflating cuff (102 in Fig. 5-7) comprising an integral gas-generating means in the form of a rupturable capsule (46 in Fig. 4) containing reactive substances that upon rupturing due to an external application of force on the cuff (102), the substances mix, initiate a chemical reaction, and produce a gas that expands the cuff (102). The expansion of the cuff (102) causes the already received fluid container (100 in Fig. 7) to be pressurized to dispense fluid through tubing (136 in Fig. 6, see Col.7, lines 3-67). However, Baron fails to disclose that after the container and tubing are received in the cuff, the expansion force of the gas is removed which causes the cuff to self-contract and compress the container to dispense the fluid. Baron fails to disclose any contraction of the cuff whatsoever, and thus fails to disclose the limitations of claims 2 and 10.
Lane discloses a self-inflating pouch (100 in Fig. 1-2 and 5) comprising an integral gas-generating means in the form of frangible compartments (110, 114, 116, 118 in Fig. 2) that when placed under tension, each consecutively rupture for a continuous production of gas for pressurizing a drug container (500 in Fig. 5, see Col.5, lines 1-15). However, Lane fails to disclose any contraction of the pouch (100), only expansion upon gas generation. Thus, Lane fails to disclose the limitations of claims 2 and 10.
Wood discloses a wearable drug delivery device (12 in Fig. 1) comprising a material delivery device (40 in Fig. 4) therewithin. The device (40) comprises an expanded, deformable reservoir (41) containing the drug which is capable of exerting contraction forces (45 in Fig. 4) to pressurized the drug therewithin for dispensing out of outlet (42 in Fig.4, see para. 0093). However, Wood fails to disclose a cuff structure that uses said contraction forces after expansion from a gas-generating mechanism to compress a separate drug container. Thus, Wood fails to disclose the limitations of claims 2 and 10.
Bryant discloses an ambulator infusion pump (see Fig. 1-2) comprising a self-inflating cuff (12, 36) in the form of a sleeve portion (36) and self-inflating bladder (12, see Col.6, lines 11-26). The self-inflating bladder (12) comprises gas-generating means in the form of a pouch (52 in Fig. 5A) containing capsules (54 in Fig. 5A) wherein rupturing of the capsules (54) initiates a chemical reaction which produces a gas for expanding the bladder (50) and pressurizing the drug container (13 in Fig. 2 and 5A, see Col.8, lines 8-40). However, Bryant fails to disclose any contraction of the bladder (50), only expansion upon gas generation which pressurizes the drug container. Thus, Bryant fails to disclose the limitations of claims 2 and 10.
Therefore, there is no reference that discloses or teaches the limitations of claims 2 and 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Attached PTO-892.
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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