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 Species D in the reply filed on June 17, 2026 is acknowledged.
While Applicant requests that consideration of claims 1-20 is requested, the examiner notes that claims 7-11 and 17-19 are withdrawn from examination as they are drawn to non-elected embodiments.
With regards to claims 7 and 17-19, the claims are drawn to seals/membranes which are rupturable in response to release of a spring-loaded assembly. This feature appears specific to non-elected species A and B.
With regards to claims 8-11, the claims are drawn to a hydraulic solution. This feature appears specific to non-elected species B.
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:
“puncturing mechanism” in claim 6. The examiner notes that this limitation is interpreted to mean “the attachment of the injector assembly”, as discussed in paragraph 70 of the published application, and functional equivalents thereof.
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 1-6 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 claim is drawn to a plurality of chambers including a mixing chamber, a first chamber having a dry component, and a second chamber having a liquid component with the components combining to form a solution in the mixing chamber. The claim further recites that the dry component is disposed within the mixing chamber in the storage state. A review of the specification seems to show that the mixing chamber is created by a union between the first and second chambers so that it is unclear how the dry component can be disposed both within the first chamber and the mixing chamber in the storage state. For examination purposes, the mixing chamber is considered to be the combined chamber of the first and second chambers.
Claims 2-6 are also rejected by virtue of being dependent on claim 1.
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) 1-5, 12-15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 5176634) in view of McCarthy (US 20090107001).
Regarding claim 1, Smith discloses an injection apparatus for administering an injectant (container 10 in fig. 1) comprising:
a plurality of chambers comprising:
a mixing chamber (combined chamber formed by compartments 18 and 20 in fig. 1; see 112(b) interpretation above) having a first impermeable membrane (seal 24 in fig. 2) disposed therein;
a first chamber containing a dry component (intermediate compartment 20 in fig. 1; 6:46-50 discloses a powder medicament); and
a second chamber containing a liquid component (upper compartment 18 in fig. 1; 4:51-54 discloses a liquid diluent), wherein the dry component and the liquid component combine to form a liquid injection solution in the mixing chamber (fig. 5; 8:67-9:10), the mixing chamber configured to retain the liquid injection solution formed by a combination of the dry component and the liquid component (fig. 5); and
wherein the injection apparatus is selectively configured in a plurality of states comprising a storage state (fig. 2) and a mixing state (fig. 5), and wherein the dry component and the liquid component are separated in the storage state and merged in the mixing state (figs. 2 and 5 shows the components are separated in the storage state by seal 24 which is ruptured 24’ in the merged state), and wherein the dry component is disposed within the mixing chamber in the storage state (the mixing chamber is considered to be the combined chambers of 18 and 20; the dry component is disclosed to be in chamber 20); and
However, Smith does not teach or disclose at least one injection needle in connection with the mixing chamber, wherein the injection needle is placed in fluid communication with the liquid injection solution in response to a rupture or penetration of a second impermeable membrane.
McCarthy teaches a similar injection apparatus (fig. 16) comprising at least one injection needle in connection with the mixing chamber (phlebotomy needle 84 in fig. 16 is in fluid connection with a mixing chamber 12; paragraph 151). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the apparatus of Smith to include injection needle of McCarthy in order to deliver the liquid injection solution to the patient.
Once modified with the needle of McCarthy, modified Smith teaches that the injection needle is placed in fluid communication with the liquid injection solution in response to a rupture or penetration of a second impermeable membrane (fig. 6 of Smith shows once seal 26 is ruptured, the solution would flow through tube 60 and to the injection needle for delivery to the patient).
Regarding claim 2, in the modified apparatus of Smith, Smith discloses the first impermeable membrane separates the liquid component from the dry component (seal 24 in fig. 2).
Regarding claim 3, in the modified apparatus of Smith, Smith discloses the first chamber is formed by a flexible pouch forming at least a portion of a perimeter seal extending about the mixing chamber (sheets 12 and 14 in fig. 2 forms a flexible pouch which also forms a perimeter seal about the mixing chamber since the mixing chamber is considered to be formed by the combined chambers of 18 and 20; 4:10-13 discloses the pouches are flexible).
Regarding claim 4, in the modified apparatus of Smith, Smith discloses the second impermeable membrane comprises a frangible seal formed between the mixing chamber and an injection assembly in fluid communication with the injection needle (fig. 6 shows the seal 24 is a breakable seal which is between the mixing chamber and a delivery device 60).
Regarding claim 5, in the modified apparatus of Smith, Smith discloses the liquid injection solution is output from the mixing chamber to the at least one injection needle by compressing the mixing chamber (9:11-18).
Regarding claim 12, Smith discloses a method for administering an injectant comprising:
providing a dry component in a first chamber (compartment 20 in fig. 2; 6:46-50 discloses a powder medicament);
providing a liquid component in a second chamber (compartment 18 in fig. 2; 4:51-54 discloses a liquid diluent);
rupturing a first seal between the first chamber and the second chamber (9:3-7 discloses rupturing seal 24 in fig. 5);
mixing the dry component and the liquid component in a third chamber forming the injectant by a combination of the dry component and the liquid component (fig. 5 shows mixing the components in a third chamber formed by the combined chambers 18 and 20);
delivering the injectant to an injector assembly via an outlet in connection with the third chamber (fig. 6 and 9:11-18 discloses delivering the injectant to delivery device 60 via outlet port 30); and
administer the injectant by applying pressure to the third chamber (fig. 6 and 9:11-18 discloses applying pressure to the chamber to cause the seal 26 to rupture to deliver the fluid to the delivery device).
However, Smith does not teach or disclose the injector assembly comprises at least one injection needle and administering the injectant via the at least one injection needle.
As discussed above, McCarthy teaches a similar method comprising providing an injector assembly (administration set 72 in fig. 16) comprising at least one injection needle (needle 84 in fig. 16) and administering the injectant via the at least one injection needle (paragraph 151). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the injector assembly to comprise the at least one injection needle of McCarthy and to incorporate the method step of administering the injectant via the at least one injection needle. This modification would enable the device to access the patients circulatory system to deliver the injectant.
Regarding claim 13, in the modified method of Smith, Smith discloses breaking a second seal disposed between the third chamber and the injector assembly (fig. 6 and 9:11-16 discloses rupturing seal 26).
Regarding claim 14, in the modified method of Smith, Smith discloses the first seal and the second seal are frangible seals broken in response to an external pressure applied to the third chamber (9:3-16 disclose compressing the chamber to rupture both seals 24 and 26).
Regarding claim 15, in the modified method of Smith, Smith discloses the third chamber is formed by a union of the first chamber and the second chamber (fig. 5 shows the third chamber is formed by rupturing seal 24 to join compartments 18 and 20).
Regarding claim 20, Smith discloses an injection apparatus configured to administer an injectant (fig. 1), the injection apparatus comprising:
a first chamber containing a dry component (compartment 20 in fig. 2; 6:46-50 discloses a powder medicament);
a second chamber containing a liquid component (compartment 18 in fig. 2; 4:51-54 discloses a liquid diluent);
a first frangible seal disposed between the first chamber and the second chamber (seal 24 in fig. 2);
a third chamber formed by a union of the first chamber and the second chamber (fig. 5);
a fluid outlet port (outlet port 30 in fig. 6); and
a second frangible seal disposed between the third chamber and the fluid outlet port (seal 26 in fig. 2), wherein:
the first frangible seal is selectively ruptured allowing the dry component to dissolve in the liquid component forming the injectant (fig. 5); and
the second frangible seal is selectively ruptured thereby placing the third chamber in fluid communication with the outlet port (fig. 6).
However, Smith does not teach or disclose the outlet port is in communication with at least one injection needle.
As discussed previously, McCarthy teaches a similar apparatus (fig. 16) comprising an outlet port (administration port 68 in fig. 16) which is in communication with at least one injection needle (needle 84 in fig. 16). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the apparatus of Smith to comprise an injection needle in communication with the outlet port, as taught by McCarthy, for the purpose of enabling the system to access and deliver the fluid to the patient (paragraph 151).
Once modified with McCarthy, modified Smith teaches that the third chamber is in fluid communication with the injection needle once the second frangible seal is ruptured since fluid would flow through the tube (administration set 60 in fig. 6) to the needle.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of McCarthy, as applied to claim 1 above, and further in view of Balteau (US 20090166363).
Regarding claim 6, modified Smith teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose a puncturing mechanism configured to rupture at least one of the first impermeable membrane and the second impermeable membrane.
Balteau teaches a similar apparatus (fig. 1) comprising a first impermeable membrane (seal 32 in fig. 1) and a second impermeable membrane (paragraph 34 discloses that tube 60 comprises a “membrane”). Balteau further teaches a puncturing mechanism configured to rupture the second impermeable membrane (this limitation is interpreted to mean an attachment of an injector assembly, as discussed above; paragraph 34 discloses the connection of a cannula or spike of an administration set).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the apparatus of modified Smith so that the outlet of Smith comprises a puncturable membrane and to comprise the claimed puncturing mechanism, as taught by Balteau. This modification would obviate the need to provide a third compartment (i.e. compartment 22 in fig. 1 of Smith) and the second seal (seal 26 in fig. 1) which would make the apparatus smaller while still ensuring the solution is not delivered to the patient until connection of the puncturing mechanism.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of McCarthy, as applied to claims 12 and 15 above, and further in view of Shi (CN 107362410).
Regarding claim 16, modified Smith teaches all of the claimed limitations set forth in claims 12 and 15, as discussed above, but does not teach or disclose applying a compressive wrap about a portion of a patient and the third chamber, thereby administering the injectant.
Shi teaches a method comprising the step of applying a compressive wrap (sleeve 1 in fig. 1) about a portion of a patient and a flexible fluid chamber (1st paragraph of pg. 5 of provided translation discloses “the sleeve 1 is sleeved upper arm of the patient” and fig. 1 shows the sleeve receiving saline bag 17; the examiner notes that the term “about” is defined by Merriam-Webster as “in the immediate neighborhood of; near” so that sleeve 1 is “about” both the patient and the fluid chamber), thereby administering the injectant (1st paragraph of pg. 5 of provided translation discloses “air pressure cavity 5 it will be expanded extruding…physiological saline bag”).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of modified Smith to include the step of applying a compressive wrap about a portion of a patient and the third chamber, thereby administering the injectant, as taught by Shi, as this would enable the apparatus of Smith to be used in a portable fashion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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