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 on 8/10/2023 and 8/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The abstract of the disclosure is objected to because:
Line 1 (Line 4 as numbered by Applicant) recites “the outside”. As the outside has not been previously introduced, Examiner suggests replacing “the outside” with “an outside” to put the abstract in clearer form.
Line 6 (Line 9 as numbered by Applicant) recites “the at least first substance”. The abstract introduces a first substance, not at least a first substance. Examiner suggests replacing “the at least first substance” in line 6 (Line 9 as numbered by Applicant) with “the first substance” to put the abstract in clearer form.
Line 7 (Line 10 as numbered by Applicant) recites “the at least first substance”. The abstract introduces a first substance, not at least a first substance. Examiner suggests replacing “the at least first substance” in line 7 (Line 10 as numbered by Applicant) with “the first substance” to put the abstract in clearer form.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 17 objected to because of the following informalities:
Line 3 recites “a fluid reservoir with a fluid”. Examiner suggests replacing “a fluid reservoir with a fluid” in line 3 of claim 17 with “a fluid reservoir holding a fluid” or “a fluid reservoir containing a fluid” to put the claim in clearer form as to what is meant by “with a fluid”.
Claim 18 objected to because of the following informalities:
Line 4 recites “is opened the first substance”. Examiner suggests adding a comma between “opened” and “the” to put the claim in clearer grammatical form.
Claim 19 objected to because of the following informalities:
Line 2-3 recites “when switching from the first state to the second state”. Examiner suggests replacing “when switching from the first state to the second state” with “when the container is switched from the first state to the second state” to put the claim in clearer form as to what structure is switched from the first state to the second state.
Claim 25 objected to because of the following informalities:
Line 1 recites “movable relative the”. Examiner suggests replacing “movable relative the” with “movable relative to the” to put the claim in clearer grammatical form.
Claim 26 objected to because of the following informalities:
Line 3 recites “such that fluid”. As claim 17 already introduces the fluid, Examiner suggests replacing “such that fluid” in line 3 of claim 26 with “such that the fluid” to put the claim in clearer form.
Claim 34 objected to because of the following informalities:
Line 3 recites “a fluid reservoir with a fluid”. Examiner suggests replacing “a fluid reservoir with a fluid” in line 3 of claim 34 with “a fluid reservoir holding a fluid” or “a fluid reservoir containing a fluid” to put the claim in clearer form as to what is meant by “with a fluid”.
Claim 35 objected to because of the following informalities:
Line 2 recites “is movable relative the”. Examiner suggests replacing “is movable relative the” in line 2 of claim 35 with “is movable relative to the” to put the claim in clearer grammatical form.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an element which is configured to open the gas sealing” in claim 23.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 17-36 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.
In regard to claim 17,
Line 10-13 recites “a second state in which the first substance is released from the first section into the housing causing an increase of gas pressure within the housing which acts on the fluid reservoir causing the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet of the autoinjector”. It is unclear the scope of the second state. It is unclear if the second state is the state in which the first substance has been released or if the second state is the state in which the first substance is actively released i.e. is released. The second state appears to require multiple steps and the scope of the second state is unclear. For examination purposes Examiner construes “a second state in which the first substance is released from the first section into the housing causing an increase of gas pressure within the housing which acts on the fluid reservoir causing the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet of the autoinjector” to be “a second state in which the first substance has been released from the first section into the housing which is configured to cause an increase of gas pressure within the housing which is configured to act on the fluid reservoir to cause the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet of the autoinjector”. Examiner suggests clarifying what is meant by the second state of the container. Examiner suggests clarifying if in the second state multiple steps (i.e. release of the first substance, increase in gas pressure, movement of fluid inside the fluid reservoir) are all required or if the second state requires the first substance to be released which is configured to cause an increase of gas pressure within the housing to act on the fluid reservoir to cause the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet of the autoinjector.
Examiner notes claims 18-32 are similarly rejected by virtue of their dependency on claim 17.
In regard to claim 19,
Line 2-3 recites “which is opened when switching from the first state to the second state”. It is unclear due to the phrase “which is opened” if claim 19 is attempting to positively require the method step of opening the gas sealing. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes the gas sealing to be configured to be opened. Examiner suggests replacing “which is opened when switching from the first state to the second state” in line 2-3 of claim 19 with “which is configured to be opened when the container is switched from the first state to the second state”.
Examiner notes claims 20-26 are similarly rejected by virtue of their dependency on claim 19.
In regard to claim 21,
Line 2 recites “the first position”. Claim 21 depends on claim 20. Claim 20 introduces a first trigger position of the trigger. It is unclear if the first position of line 2 of claim 21 is the same as the first trigger position or if the first position is an additional first position of the trigger. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the first position” in line 2 of claim 21 with “the first trigger position”.
Line 2-3 recites “the second position”. Claim 21 depends on claim 20. Claim 20 introduces a second trigger position of the trigger. It is unclear if the second position of line 2-3 of claim 21 is the same as the second trigger position or if the second position is an additional second position of the trigger. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the second position” in line 2-3 of claim 21 with “the second trigger position”.
In regard to claim 25,
Line 1-7 recites “wherein the outlet interface is movable relative the longitudinal axis from a first interface position to a second interface position and which is in fluid communication with the outlet, wherein - in the first interface position the outlet interface is not in fluid communication with a delivery tube, in the second interface position the outlet interface is in fluid communication with the delivery tube”. It is unclear the scope of this claim. The outlet interface is claimed as being movable relative the longitudinal axis from a first interface position to a second interface position i.e. a functional limitation. Claim 25 further defines the first interface position and the second interface position which are not positively required and introduces a delivery tube. It is unclear if the delivery tube is positively required by the claim and if the delivery tube is a structure of the autoinjector. For examination purposes Examiner construes the delivery tube as not being positively required.
Examiner notes claim 26 is similarly rejected by virtue of its dependency on claim 25.
In regard to claim 26,
Line 1-4 recites “wherein the delivery tube is configured to be in fluid communication with the fluid reservoir and which is configured to be in fluid communication with the outlet, such that fluid from the fluid reservoir is movable from the fluid reservoir through the delivery tube to the outlet”. Claim 26 depends on claim 25. It is unclear if claim 26 is attempting to positively require the delivery tube which is not positively required by claim 25 as detailed above by further limiting the delivery tube. For examination purposes Examiner construes the delivery tube as not being positively required. Examiner suggests positively introducing the delivery tube before further defining the delivery tube.
Line 1-3 recites “wherein the delivery tube is configured to be in fluid communication with the fluid reservoir and which is configured to be in fluid communication with the outlet”. It is unclear what structure, the delivery tube or the fluid reservoir, is configured to be in fluid communication with the outlet. For examination purposes Examiner construes the delivery tube to be configured to be in fluid communication with the outlet.
In regard to claim 30,
Line 1-2 recites “wherein the fluid reservoir comprises a medicament or drug”. Claim 30 depends on claim 17. Claim 17 introduces a fluid reservoir with a fluid. It is unclear if the medicament or drug is in addition to the fluid i.e. a medicament or drug and a fluid are contained within the fluid reservoir or if the fluid is the same as the medicament or drug. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “wherein the fluid reservoir comprises a medicament or drug” with “wherein the fluid is a medicament or drug”.
In regard to claim 33,
Line 4 recites “a fluid”. Line 1 recites “for dispensing a medicament”. It is unclear if the fluid is in addition to the medicament or if the fluid is the same as the medicament. Based on the disclosure they appear to be the same. Examiner suggests replacing “causing a fluid” in line 4 of claim 33 with “causing the medicament”.
In regard to claim 34,
Line 7-10 recites “a second state in which the first substance is released from the first section into the housing causing an increase of gas pressure within the housing which acts on the fluid reservoir causing the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet of the autoinjector”. It is unclear the scope of the second state. It is unclear if the second state is the state in which the first substance has been released or if the second state is the state in which the first substance is actively released i.e. is released. The second state appears to require multiple steps and the scope of the second state is unclear. For examination purposes Examiner construes “a second state in which the first substance is released from the first section into the housing causing an increase of gas pressure within the housing which acts on the fluid reservoir causing the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet of the autoinjector” to be “a second state in which the first substance has been released from the first section into the housing which is configured to cause an increase of gas pressure within the housing which is configured to act on the fluid reservoir to cause the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet of the autoinjector”. Examiner suggests clarifying what is meant by the second state of the container. Examiner suggests clarifying if in the second state multiple steps (i.e. release of the first substance, increase in gas pressure, movement of fluid inside the fluid reservoir) are all required or if the second state requires the first substance to be released which is configured to cause an increase of gas pressure within the housing to act on the fluid reservoir to cause the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet of the autoinjector.
Examiner notes claims 35-36 are similarly rejected by virtue of their dependency on claim 34.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17 and 30-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haar (U.S. PG publication 20030114789).
In regard to claim 17,
Haar discloses an autoinjector (figure 1, item 11) comprising:
- a housing (figure 1, item 21) which is gas-tight to ambient environment (paragraph [0098] and [0082]);
- a fluid reservoir (figure 1, item 14) with a fluid (paragraph [0085]), wherein the fluid reservoir comprises a flexible material (paragraph [0085]); and
- a container (figure 1, item 23) which comprises at least a first section (section which item 24 is within) which is configured to contain a first substance (figure 1, item 24; Examiner notes “configured to contain a first substance” is a functional limitation. The first substance is not positively required by the claim. The container is fully capable of the recited function due to its structure) which comprises gas or which can be converted into gas (paragraph [0089]), wherein
- the container is configured to assume a first state (state shown in figure 1 in which item 42 has not burst; paragraph [0102]) in which the first section is sealed so that the first substance is contained in the first section (see figure 1), and
a second state (state in which item 42 has burst) in which the first substance is released from the first section into the housing causing an increase of gas pressure within the housing which acts on the fluid reservoir causing the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet (figure 1, item 17) of the autoinjector (paragraph [0102] and [0089]).
In regard to claim 30,
Haar discloses the autoinjector of claim 17, wherein the fluid reservoir comprises a medicament or drug (paragraph [0085]).
In regard to claim 31,
Haar discloses the autoinjector of claim 17, being a disposable or single-use device for providing a single dose (paragraph [0008]).
In regard to claim 32,
Haar discloses the autoinjector of claim 17, wherein the fluid reservoir is arranged at a base of the housing along a circle segment (see figure 1), and the container is arranged inside the housing and at least partially circumferentially surrounded by the fluid reservoir (see figure 1: wherein the container is arranged inside the housing and at least partially circumferentially surrounded by the fluid reservoir on one side).
In regard to claim 33,
Haar discloses a method for dispensing a medicament (paragraph [0085]-[0086]) using an autoinjector (figure 1, item 11), the method comprising:
releasing a first section (figure 1, item 42) of the autoinjector into a housing (figure 1, item 21) of the autoinjector causing an increase of gas pressure within the housing (paragraph [0028], [0102] and [0089]) which acts on a fluid reservoir (figure 1, item 14) causing a fluid (medicament; paragraph [0085]) inside the fluid reservoir to move through the fluid reservoir towards and through an outlet (figure 1, item 17) of the autoinjector (paragraph [0086] and [0089]), wherein the housing is gas-tight to ambient environment (paragraph [0098] and [0082]), the fluid reservoir comprises a flexible material (paragraph [0086] and [0089]), and the container is configured to contain a first substance (figure 1, item 24) which comprises gas or which can be converted into gas (paragraph [0088]-[0089]).
In regard to claim 34,
Haar discloses an autoinjector (figure 1, item 11) comprising:
a housing (figure 1, item 21) which is gas-tight to ambient environment (paragraph [0098] and [0082]);
a fluid reservoir(figure 1, item 14) with a fluid (paragraph [0085]), wherein the fluid reservoir comprises a flexible material (paragraph [0085]);
a container (figure 1, item 23) which comprises at least a first section (section which item 24 is within) which is configured to contain a first substance (figure 1, item 24; Examiner notes “configured to contain a first substance” is a functional limitation. The first substance is not positively required by the claim. The container is fully capable of the recited function due to its structure) which comprises gas or which can be converted into gas (paragraph [0089]), wherein the container is configured to assume a first state (state shown in figure 1 in which item 42 has not burst; paragraph [0102]) in which the first section is sealed so that the first substance is contained in the first section (see figure 1), and a second state (state in which item 42 has burst) in which the first substance is released from the first section into the housing causing an increase of gas pressure within the housing which acts on the fluid reservoir causing the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet (figure 1, item 17) of the autoinjector (paragraph [0102] and [0089]); and
a trigger (ignition pin 26; paragraph [0088]) which is movable along a longitudinal axis from a first trigger position to a second trigger position (Examiner notes “movable along a longitudinal axis from a first trigger position to a second trigger position” is a functional limitation. The trigger is fully capable of the recited function as the trigger can be moved from a first trigger position in which the trigger and the autoinjector are away from the injection site to a second trigger position in which the autoinjector and trigger have been moved closed to the injection site).
In regard to claim 35,
Haar discloses the autoinjector of claim 34, further comprising:
- an outlet interface (figure 1, item 16) which is movable relative the longitudinal axis from a first interface position to a second interface position (Examiner notes “movable relative the longitudinal axis from a first interface position to a second interface position” is a functional limitation. The outlet interface is fully capable of the recited function as the outlet interface can be moved from a first interface position in which the outlet interface and the autoinjector are away from the injection site to a second interface position in which the autoinjector and the outlet interface have been moved closed to the injection site) and which is in fluid communication with the outlet (see figure 1; paragraph [0086]).
In regard to claim 36,
Haar discloses the autoinjector of claim 34, wherein the container is arranged around the longitudinal axis (see figure 1).
Claims 17, 30-32, and 34-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jacobsen (U.S. Patent no 6045534).
In regard to claim 17,
Jacobsen discloses an autoinjector (figure 2A-2D, item 10) comprising:
- a housing (figure 2A-2D, item 24 and 12) which is gas-tight to ambient environment (see figure 2A wherein at least a portion of the housing is gas-tight to ambient environment when solder is within item 63 and gas is not allowed to escape the portion of the housing; column 5, line 15-30; Examiner notes the claim doesn’t specify that the housing is gas-tight to ambient environment during the entire use of the autoinjector);
- a fluid reservoir (figure 2B, item 18 and 21) with a fluid (column 4, line 30-36), wherein the fluid reservoir comprises a flexible material (figure 2A-2D, item 21); and
- a container (see figure 2A wherein item 52 forms a container which holds item 58) which comprises at least a first section (section which item 52 is within) which is configured to contain a first substance (item 52) which comprises gas or which can be converted into gas (column 5, line 3-11), wherein
- the container is configured to assume a first state (see figure 2A) in which the first section is sealed so that the first substance is contained in the first section (see figure 2A), and
a second state (state in which propellant is ignited; figure 2B) in which the first substance is released from the first section into the housing (see figure 2B) causing an increase of gas pressure within the housing which acts on the fluid reservoir causing the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet (figure 2A-2D, item 22 forms an outlet) of the autoinjector (column 5, line 30-55).
In regard to claim 30,
Jacobsen discloses the autoinjector of claim 17, wherein the fluid reservoir comprises a medicament or drug (column 4, line 30-36).
In regard to claim 31,
Jacobsen discloses the autoinjector of claim 17, being a disposable or single-use device for providing a single dose (column 2, line 49-52).
In regard to claim 32,
Jacobsen discloses the autoinjector of claim 17, wherein the fluid reservoir is arranged at a base of the housing along a circle segment (see figure 2A-2D), and the container is arranged inside the housing and at least partially circumferentially surrounded by the fluid reservoir (see figure 2A-2D).
In regard to claim 34,
Jacobsen discloses an autoinjector (figure 2A-2D, item 10) comprising:
a housing (figure 2A-2D, item 24 and 12) which is gas-tight to ambient environment (see figure 2A wherein at least a portion of the housing is gas-tight to ambient environment when solder is within item 63 and gas is not allowed to escape the portion of the housing; column 5, line 15-30; Examiner notes the claim doesn’t specify that the housing is gas-tight to ambient environment during the entire use of the autoinjector);
a fluid reservoir (figure 2B, item 18 and 21) with a fluid (column 4, line 30-36), wherein the fluid reservoir comprises a flexible material (figure 2A-2D, item 21);
a container (see figure 2A wherein item 52 forms a container which holds item 58) which comprises at least a first section (section which item 52 is within) which is configured to contain a first substance (item 52) which comprises gas or which can be converted into gas (column 5, line 3-11), wherein the container is configured to assume a first state (see figure 2A) in which the first section is sealed so that the first substance is contained in the first section (see figure 2A), and a second state (state in which propellant is ignited; figure 2B) in which the first substance is released from the first section into the housing (see figure 2B) causing an increase of gas pressure within the housing which acts on the fluid reservoir causing the fluid inside the fluid reservoir to move through the fluid reservoir towards and through an outlet (figure 2A-2D, item 22 forms an outlet) of the autoinjector (column 5, line 30-55); and
a trigger (figure 1, item 32) which is movable along a longitudinal axis from a first trigger position to a second trigger position (Examiner notes “movable along a longitudinal axis from a first trigger position to a second trigger position” is a functional limitation. The trigger is fully capable of the recited function as the trigger can be moved from a first trigger position in which the trigger and the autoinjector are away from the injection site to a second trigger position in which the autoinjector and trigger have been moved closed to the injection site).
In regard to claim 35,
Jacobsen discloses the autoinjector of claim 34, further comprising:
- an outlet interface (figure 2A-2D, item 20) which is movable relative the longitudinal axis from a first interface position (see position in figure 2A) to a second interface position (see position in figure 2B) and which is in fluid communication with the outlet (see figure 2A-2B).
In regard to claim 36,
Jacobsen discloses the autoinjector of claim 34, wherein the container is arranged around the longitudinal axis (see figure 2A-2D).
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.
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.
Claims 18-27 are rejected under 35 U.S.C. 103 as being unpatentable over Haar (U.S. PG publication 20030114789) further in view of Schwebel (U.S. Patent no 3802430) as evidenced by Sancoff (U.S. patent no 5700245).
In regard to claim 18,
Haar discloses the autoinjector of claim 17.
The first embodiment of Haar fails to disclose wherein the container comprises a second section which is configured to contain a second substance which can be converted into gas, wherein the first section and the second section are separated by a separation member, such that when the separation member is opened the first substance, which comprises a substance which can be converted into gas, mixes with the second substance and generates gas.
A second embodiment of Haar teaches wherein the container comprises a second section (see figure 12 wherein the portion of the container 23 which item 24 is within is construed as the second section and the portion which item 72 is within is construed as the first section; Examiner notes the propellent is ignited by item 71 under a spring force contacting item 72 as disclosed in paragraph [0196]) which is configured to contain a second substance (figure 12, item 24) which can be converted into gas (Examiner notes “configured to contain a second substance which can be converted into gas” is a functional limitation. The second substance is not positively required by the claim. The second section is fully capable of containing a second substance which can be converted into gas due to its structure).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Haar to substitute the container and mechanism for igniting the propellent (i.e. item 26) of the first embodiment of Haar for the container which contains a first section and a second section of the second embodiment of Haar and to include item 71 and spring (see paragraph [0196] of Haar) which is used for igniting the propellent, as taught by the second embodiment of Haar, because the substitution is a simple substitution that would yield the same predictable result of producing gas (paragraph [0193] and [0088] of Haar). Furthermore, Haar discloses modifications can be made (paragraph [0229]).
The first embodiment of Haar in view of the second embodiment of Haar fails to disclose wherein the first section and the second section are separated by a separation member, such that when the separation member is opened the first substance, which comprises a substance which can be converted into gas, mixes with the second substance and generates gas.
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Schwebel teaches wherein the container (see figure 1 above) comprises a second section (section which item 25 is within which is surrounded by a membrane) which is configured to contain a second substance which can be converted into gas (Examiner notes “configured to contain a second substance which can be converted into gas” is a functional limitation. The second substance is not positively required by the claim. The second section is fully capable of containing a second substance which can be converted into gas due to its structure and further as evidenced by Sancoff which supports a first substance 65 within a first section (see figure 1 of Sancoff) can be mixed with a second substance 80 in a second section to form gas (see figure 2 of Sancoff)), wherein the first section (section which item 26 is within of Schwebel which is surrounded by a membrane and which can be pierced by item 27 as shown in figure 2 of Schwebel) and the second section are separated by a separation member (see figure 1 of Schwebel above), such that when the separation member is opened the first substance, which comprises a substance which can be converted into gas, mixes with the second substance and generates gas (Examiner notes “such that when the separation member is opened the first substance, which comprises a substance which can be converted into gas, mixes with the second substance and generates gas” is a functional limitation. As noted above, the first substance and the second substance are not positively required by the claim. The autoinjector is fully capable of the recited function due to its structure as shown in figure 2 of Schwebel and as further evidenced by Sancoff which supports that when the separation member (item 75 of Sancoff) is opened the first substance 65, which comprises a substance which can be converted into gas, mixes with the second substance 80 and generates gas (see figure 2 of Sancoff)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Haar to include a membrane surrounding the first section and a membrane surrounding the second section, therefore resulting in wherein the first section and the second section are separated by a separation member (membrane surrounding the second section), such that when the separation member is opened the first substance, which comprises a substance which can be converted into gas, mixes with the second substance and generates gas and to also modify item 71 of Haar accordingly to be able to pierce the membrane surrounding the first section, as taught by Schwebel as evidenced by Sancoff, for the purpose of reducing accidental discharge (column 2, line 18-20 of Schwebel).
In regard to claim 19,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 18, wherein the container comprises a gas sealing (see analysis of claim 18 above wherein the membrane which surrounds the first section forms a gas sealing; see figure 1 of Schwebel in which the membrane shown around item 26 is the gas sealing) which seals the first and/or second section (seals the first section) and which is opened when switching from the first state to the second state (see second state shown in figure 2 of Schwebel in which the gas sealing is opened).
In regard to claim 20,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 19, comprising a trigger (see analysis of claim 18 above wherein the trigger is item 71 of Haar which can pierce the membrane/gas seal surrounding the first section as modified by Schwebel) which is movable along a longitudinal axis from a first trigger position (position in which trigger has not moved) to a second trigger position (position in which the trigger is in contact with the membrane/gas seal surrounding the first section as shown in figure 2 of Schwebel), wherein
- in the first trigger position the trigger is separated from the gas sealing (see analysis above; see figure 1 of Schwebel),
- in the second trigger position the trigger is in mechanical contact with the gas sealing, thereby opening the gas sealing (see analysis above; see figure 2 of Schwebel), such that gas is releasable from the container into the housing and thereby increasing the gas pressure inside the housing, such that the fluid reservoir is squeezed and the fluid inside the fluid reservoir is moved to the outlet (Examiner notes “such that gas is releasable from the container into the housing and thereby increasing the gas pressure inside the housing, such that the fluid reservoir is squeezed and the fluid inside the fluid reservoir is moved to the outlet” is a functional limitation; see figure 2 of Schwebel and paragraph [0102] and [0089] of Haar).
In regard to claim 21,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 20, comprising a trigger spring (spring disclosed in paragraph [0196] of Haar) which is mechanically connected to the trigger such that when the trigger moves from the first position to the second position the trigger moves the trigger spring from a first position to a second position (paragraph [0196] of Haar).
In regard to claim 22,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 20, wherein the trigger is integrated into the housing (see figure 12 of Haar and analysis above).
In regard to claim 23,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 20, wherein the trigger comprises an element (portion of item 71 which directly contact the gas sealing; see analysis above) which is configured to open the gas sealing (see analysis above and figure 2 of Schwebel).
In regard to claim 24,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 20, comprising a trigger sealing (figure 1, item 19 of Haar) which seals an outlet interface (figure 1, item 16 of Haar) between the housing and the trigger (see figure 1 and 12 of Haar wherein the outlet interface is located between the trigger and a portion of the housing), to contribute to the housing being gas-tight (see figure 1 of Haar; due to item 19 sealing item 17 of Haar, item 19 contributes to the housing being gas tight).
In regard to claim 25,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 24, wherein the outlet interface is movable relative the longitudinal axis from a first interface position (position in which item 19 of Haar covers item 17 of Haar and the autoinjector is away from an injection site) to a second interface position (position in which item 19 of Haar has been removed and the entire autoinjector has been moved along the longitudinal axis towards an injection site; Examiner notes wherein the outlet interface is movable relative the longitudinal axis from a first interface position to a second interface position is a functional limitation. The outlet interface is fully capable of the recited function due to its structure) and which is in fluid communication with the outlet (see figure 1 of Haar wherein item 16 is in fluid communication with item 17), wherein
- in the first interface position the outlet interface is not in fluid communication with a delivery tube (Examiner notes the delivery tube is not positively required by the claim since the outlet interface is claimed as being movable relative the longitudinal axis from a first interface position to a second interface position is a functional limitation which is a functional limitation; Examiner notes the outlet interface is not in fluid communication with a delivery tube due to the presence of the item 19 of Haar),
- in the second interface position the outlet interface is in fluid communication with the delivery tube (see figure 1 of Haar in which once item 19 of Haar is removed, a delivery tube is fully capable of being attached in the second interface position to enable the outlet interface to be in fluid communication with the delivery tube).
In regard to claim 26,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 25, wherein the delivery tube is configured to be in fluid communication with the fluid reservoir and which is configured to be in fluid communication with the outlet, such that fluid from the fluid reservoir is movable from the fluid reservoir through the delivery tube to the outlet (see analysis above wherein the delivery tube is not positively required by the claim; a delivery tube is fully capable of the recited function; Examiner notes the claim does not require the fluid to be moved from the fluid reservoir directly to the delivery tube) .
In regard to claim 27,
The first embodiment of Haar in view of the second embodiment of Haar in view of Schwebel as evidenced by Sancoff teaches the autoinjector of claim 18, wherein the separation member is configured to be opened during assembly of the autoinjector or by a tool (Examiner notes “configured to be opened during assembly of the autoinjector or by a tool” is a functional limitation. The separation member is fully capable of the recited function due to its structure; see analysis of claim 18 above; see figure 2 of Schwebel; Examiner notes a tool is not positively required by the claim; various structure could function as a tool to open the separation member. For example, the separation member is opened indirectly by item 71 of Haar which is a tool).
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen (U.S. Patent no 6045534) further in view of Jacobsen (U.S. Patent no 5860957). For clarity purposes Jacobsen (U.S. Patent no 5860957) will be referred to as Jacobsen957.
In regard to claim 28,
Jacobsen discloses the autoinjector of claim 17, wherein the outlet comprises a needle (see figure 2A-2D wherein the outlet comprises a needle), which is movable along a longitudinal axis from a first needle position (see figure 2A) to a second needle position (see figure 2B), wherein in the first needle position the needle is completely contained in the housing (see figure 2A), and in the second needle position (see figure 2B) at least a portion of the needle has moved through the housing (see figure 2B wherein the needle has moved through base 24 of the housing)
Jacobsen fails to disclose in the second needle position at least a portion of the needle has moved through a housing sealing.
Jacobsen957 teaches in the second needle position (see figure 8B) at least a portion of the needle (figure 8A, item 502) has moved through a housing sealing (figure 8A, item 540; Examiner notes a housing sealing is placed below the base 536 of the housing).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Jacobsen to include a housing sealing attached to base 24 of Jacobsen, as taught by Jacobsen957, for the purpose of keeping the needle sterile and for the purpose of keeping the needle from inadvertently scratching a patient (column 12, line 19-30 of Jacobsen957).
In regard to claim 29,
Jacobsen in view of Jacobsen957 teaches the autoinjector of claim 28, wherein the housing has a shape with a base (figure 2A-2D, item 24 of Jacobsen957) which has a diameter larger than a height (see figure 2A-2D of Jacobsen957 wherein the diameter of item 24 is larger than a height of item 24), which extends along the longitudinal axis (see figure 2A-2D of Jacobsen957).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Thielen (U.S. Patent no 6258062) discloses an autoinjector (figure 5A, item 5) comprising a housing which is gas-tight to ambient environment (column 6, line 27-30).
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785