DETAILED ACTION
This office action is in response to the Amendments/Remarks filed January 22, 2026.
The amendments of claims 57 and 79 are acknowledged.
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 .
Response to Arguments
Applicants arguments that Kragelund does not disclose a pooling device with a second flow passageway separate from a first flow passageway such that fluid communication between the second flow passageway and the first flow passageway is closed is not persuasive as Kragelund discloses fluid communication between the second flow passageway and the first flow passageway is closed (see par. 103, flow control member, in the form of a dial plug, enables a user to selectively switch between a first state in which flow is enabled between first port 11 and third port 13 via pathway 14 and between third port 13 and second port 12 via second fluid pathway, and a second state in which fluid flow is enabled between the second port 12 and third port 13 via third fluid pathway 16 and par. 115, 129).
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: “locking mechanism configured for securely holding the first container unit in the first cavity during use” in claims 68 and 69 and “locking mechanism” of claim 76, and as described on page 20, lines 10-14 of the originally filed specification.
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 § 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.
Claim(s) 57, 58, 65 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kragelund et al. (US 2012/0029464), disclosed in the September 25, 2023 IDS.
Regarding claim 57, Kragelund discloses a pooling device for pooling a medicinal fluid (see Figs. 1, 3-4, 7), comprising: one or more inlets 124 configured for receiving ambient air (see par. 105); one or more outlets 13, 74 configured for delivering the medicinal fluid to an attachment (see par. 98, 129 port 13 has releasable coupling configuration considered attachment and fluid goes through outlet 74 to get to attachment); a first cavity 11, 12, 29 configured for accommodating insertion of a first container unit 26 having a first container 2 configured to store a first fluid 8 (see par. 93) and a second container 3 configured to store a second fluid (see Fig. 1, container could also store a second fluid), a first spike 30 disposed in the first cavity (see Figs. 3-4, 7) and configured for puncturing a stopper of the first container (see par. 94, 97) when the first container unit transitions from an upper position to a lower position (see Fig. 7, upper position would be position above but not with spike in septum and lower position would be fully pushed in with spike penetrating septum, like in Fig. 1); a second spike 57 (see Fig. 7, par. 110) disposed in the first cavity and configured for puncturing a stopper of the second container when the first container unit transitions from an upper position to a lower position (see Fig. 7, par. 94, 97, upper position would be position above but not with spike in septum and lower position would be fully pushed in with spike penetrating septum, like in Fig. 1); a first flow passageway 14 (see Fig. 1) connected to the first spike and configured to convey the first fluid from the first container to a first outlet 13 of the one or more outlets 13; and a second flow passageway (see Fig. 1, part of passageway 16 separate from passageway 14) separate from the first flow passageway (see Fig. 1) such that fluid communication between the second flow passageway and the first flow passageway is closed (see par. 103, flow control member, in the form of a dial plug, enables a user to selectively switch between a first state in which flow is enabled between first port 11 and third port 13 via pathway 14 and between third port 13 and second port 12 via second fluid pathway, and a second state in which fluid flow is enabled between the second port 12 and third port 13 via third fluid pathway 16 and par. 115, 129), wherein the second flow passageway is connected to the second spike (see Figs. 1, 3-4, 7) and configured to convey the second fluid from the second container to a second outlet 74 of the one or more outlets (see Fig. 1, par. 129).
Regarding claim 58, Kragelund discloses the first cavity is dimensions such that the first container unit can only be inserted into the first cavity in a single orientation (see Fig. 7, due to portion 29 of first cavity, the container unit has to be placed with container 2 interacting with spike 30 and container 3 interacting with spike 57).
Regarding claim 65, Kragelund discloses the first spike includes a first channel 32 connected to the one or more inlets and a second channel 31 connected to the first outlet (see Fig. 3).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 59-61 and 63-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kragelund in view of Radmer et al. (US 2009/0182300), disclosed in the September 25, 2023 IDS.
Regarding claim 59, Kragelund discloses the limitation of claim 57 but does not disclose a second cavity configured for accommodating insertion of a second container unit having a third container configured to store a third fluid and a fourth container configured to store a fourth fluid, a third spike disposed in the second cavity and configured for puncturing a stopper of the third container when the second container unit transitions from an upper position to a lower position, wherein the third spike is connected to the first flow passageway and the first flow passageway is further configured to convey the third fluid from the third container to the first outlet; and a fourth spike disposed in the second cavity and configured for puncturing a stopper of the fourth container when the second container unit transitions from an upper position to a lower position, wherein the fourth spike is connected to the second flow passageway and the second flow passageway is further configured to convey the fourth fluid from the fourth container to the second outlet.
Radmer discloses a drug mixing device having an outlet 17 connected to two containers 5, 21, each of the two containers in a holder for the containers (see Fig. 3, par. 68-69), with multiple holders connected to each other in a series (see Fig. 3) in order to reconstitute from many containers instead of just two (see par. 68). Kragelund discloses a single holder for the first and second container (see Fig. 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the pooling device of Kragelund contain multiple holders as disclosed by Radmer in order to reconstitute from more than two containers. The second holder would therefore have a second cavity similar to the first cavity, configured for accommodating insertion of a second container unit having a third container configured to store a third fluid and a fourth container configured to store a fourth fluid (see Kragelund, Fig. 7 and Radmer, Fig. 3), a third spike disposed in the second cavity and configured for puncturing a stopper of the third container when the second container unit transitions from an upper position to a lower position (see Kragelund, Fig. 7, par. 94, 97), wherein the third spike is connected to the first flow passageway and the first flow passageway is further configured to convey the third fluid from the third container to the first outlet (see Radmer, Fig. 3, containers in series all connected to outlet 17 which would then cause first-fourth containers of Kragelund and Radmer to all be connected to outlet 13 of Kragelund); and fourth spike disposed in the second cavity and configured for puncturing a stopper of the fourth container when the second container unit transitions from an upper position to a lower position (see Kragelund, Fig. 7, par. 94, 97), wherein the fourth spike is connected to the second flow passageway and the second flow passageway is further configured to convey the fourth fluid from the fourth container to the second outlet (see Radmer, Fig. 3, containers in series all connected to outlet 17 which would then cause first-fourth containers of Kragelund and Radmer to all be connected to outlet 74 of Kragelund due to the capability of syringe 20 of reconstituting fluid into container 3 and through second flow passageway and outlet 74).
Regarding claim 60, Kragelund and Radmer disclose the limitations of claim 59 and “the first fluid and the third fluid are both a first type fluid, and wherein the second fluid and the fourth fluid are both a second type fluid, and wherein the first type fluid and the second type fluid are different fluid types” are considered function language as the first container units and the second containers units are required to be configured to hold such a fluid, not actually required to hold such a fluid. As the containers of Kragelund are configured in way such that they can hold such fluids (see Figs. 1, 3, 7, containers look the same and one holds powder and the other holds liquid, both with septums preventing leaks as described in par. 94, 97), they are interpreted as fulfilling the required limitations.
Regarding claim 61, Kragelund and Radmer disclose the limitations of claim 59 and as the second holder would have a similar cavity to the first holder in Kragelund, the second cavity would be dimensioned such that the second container unit can only be inserted into the second cavity in a single orientation (see Fig. 7, due to portion 29 of first cavity, the container unit has to be placed with container 2 interacting with spike 30 and container 3 interacting with spike 57).
Regarding claim 63, Kragelund and Radmer disclose the limitations of claim 59 and as Radmer discloses a third holder, there would be a third cavity configured for accommodating insertion of a third container unit having a fifth container configured to store a fifth fluid and a sixth container configured to store a sixth fluid (see Kragelund, Fig. 7 and Radmer, Fig. 3), a fifth spike disposed in the third cavity and configured for puncturing a stopper of the fifth container when the third container unit transitions from an upper position to a lower position (see Kragelund, Fig. 7, par. 94, 97), wherein the fifth spike is connected to the first flow passageway and the first flow passageway and the first flow passageway is further configured to convey the fifth fluid from the fifth container to the first outlet (see Radmer, Fig. 3, containers in series all connected to outlet 17 which would then cause first-sixth containers of Kragelund and Radmer to all be connected to outlet 13 of Kragelund); and a sixth spike disposed in the third cavity and configured for puncturing a stopper of the sixth container when the third container unit transitions from an upper position to a lower position (see Kragelund, Fig. 7, par. 94, 97), wherein the sixth spike is connected to the second flow passageway and the second flow passageway is further configured to convey the sixth fluid form the sixth container to the second outlet (see Radmer, Fig. 3, containers in series all connected to outlet 17 which would then cause first-sixth containers of Kragelund and Radmer to all be connected to outlet 74 of Kragelund due to the capability of syringe 20 of reconstituting fluid into container 3 and through second flow passageway and outlet 74).
Regarding claim 64, Kragelund and Radmer disclose the limitations of claim 63 but do not disclose a fourth cavity configured for accommodating insertion of a fourth container unit having a seventh container configured to store a seventh fluid and an eighth container configured to store an eighth fluid, a seventh spike disposed in the fourth cavity and configured for puncturing a stopper of the seventh container when the fourth container unit transitions from an upper position to a lower position, wherein the seventh spike is connected to the first flow passageway and the first flow passageway is further configured to convey the seventh fluid from the seventh container to the first outlet; and an eighth spike disposed in the fourth cavity and configured for puncturing a stopper of the eighth container when the fourth container unit transitions from an upper position to a lower position, wherein the eighth spike is connected to the second flow passageway and the second flow passageway is further configured to convey the eighth fluid from the eighth container to the second outlet.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include an additional, fourth holder, to the device of Kragelund and Radmer, as the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), and here the additional holder would be acting similarly to other holders and therefore there would be no new and unexpected result. Accordingly, there would be a fourth cavity configured for accommodating insertion of a fourth container unit having a seventh container configured to store a seventh fluid and an eighth container configured to store an eighth fluid (see Kragelund, Fig. 7 and Radmer, Fig. 3), a seventh spike disposed in the fourth cavity and configured for puncturing a stopper of the seventh container when the fourth container unit transitions from an upper position to a lower position (see Kragelund, Fig. 7, par. 94, 97), wherein the seventh spike is connected to the first flow passageway and the first flow passageway is further configured to convey the seventh fluid from the seventh container to the first outlet see Radmer, Fig. 3, containers in series all connected to outlet 17 which would then cause first-sixth containers of Kragelund and Radmer to all be connected to outlet 13 of Kragelund); and an eighth spike disposed in the fourth cavity and configured for puncturing a stopper of the eighth container when the fourth container unit transitions from an upper position to a lower position (see Kragelund, Fig. 7, par. 94, 97), wherein the eighth spike is connected to the second flow passageway and the second flow passageway is further configured to convey the eighth fluid from the eighth container to the second outlet (see Radmer, Fig. 3, containers in series all connected to outlet 17 which would then cause first-sixth containers of Kragelund and Radmer to all be connected to outlet 74 of Kragelund due to the capability of syringe 20 of reconstituting fluid into container 3 and through second flow passageway and outlet 74).
Claim(s) 66-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kragelund in view of Tachikawa et al. (US 2005/0126653), disclosed in the September 25, 2023 IDS.
Regarding claim 66, Kragelund discloses the limitations of claim 65 but does not disclose a spike sheath connecting the first channel and the second channel in fluid communication when the spike sheath is unpunctured.
Tachikawa discloses a first spike sheath 5 covering a first spike 3 (see Figs. 1-3) such that the tip portion of the spike is spaced from the sheath (see Fig. 2, open space between the tip of the spike and sheath), made of elastic materials such as rubber, and is configured to be punctured (see para. 41) and compressed when the container moves from a position adjacent the spike to a position in which the spike is inside the container (see Fig. 2-3). Tachikawa further discloses the sheath for pollution preventive means of spike 3 (see para. 39-41). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further include a spike sheath such that the tip portion of the spike is spaced from the sheath made of elastic materials such as rubber, and configured to be punctured and compressed when the container moves from a position adjacent the spike to a position in which the spike is inside the container, in order to help prevent pollution of the spike, as disclosed by Tachikawa. Consequently, the space would allow the first and second channels to be in fluid communication.
Regarding claim 67, Kragelund and Tachikawa disclose the limitations of claim 66 and Tachikawa further discloses the spike sheath is configured to be punctured and compressed when the first container unit transitions from the upper position to the lower position (see Figs. 2, 4, when container pushes down to the lower position it would push on sheath and compress while also allowing spike sheath punctured).
Claim(s) 68-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kragelund in view of Beyer et al. (US 2015/0029816).
Regarding claim 68, Kragelund discloses the limitations of claim 57 but does not disclose a locking mechanism configured for securely holding the first container unit in the first cavity during use.
Beyer discloses a container 2 held in a cavity via a locking mechanism 52 configured to securely hold the container in the cavity during use (see Fig. 2, cl. 19, par. 33, 61). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device of Kragelund further include a locking mechanism as disclosed by Beyer to lock the container in place (see Beyer, par. 33).
Regarding claim 69, Kragelund and Beyer disclose the limitations of claim 68, and Beyer further discloses the locking mechanism 52 is disposed on an inner wall of the cavity (see Fig. 2), which would be the first cavity of Kragelund as disclosed above in the rejection of claim 57.
Claim(s) 70-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kragelund in view of Kraushaar (US 2010/0305548).
Regarding claim 70, Kragelund discloses a method of operating a pooling device for pooling a medicinal fluid (see Figs. 1, 3-4, 7), the method comprising: inserting a first container unit 26 including a first container 2 containing a first fluid (see par. 93) and a second container containing 3 into a first cavity 11, 12, 29; moving the first container unit from an upper position to a lower position in the first cavity (see Fig. 7, upper position would be position above but not with spike in septum and lower position would be fully pushed in with spike penetrating septum, like in Fig. 1); piercing a stopper of the first container with a first spike 30 disposed in the first cavity (see par. 94, 97); allowing the first fluid to flow from the first container into the first spike, through a first flow passageway 14, and to a first outlet 13 of the pooling device (see Fig. 1, 7); piercing a stopper of the second container with a second spike 57 disposed in the first cavity (see Figs. 1, 7, par. 110); and allowing fluid to flow from the second container into the second spike, through a second flow passageway separate from the first flow passageway (see Fig. 1, passageway 16 that doesn’t overlap with passageway 14), and to a second outlet 74 of the pooling device (see Fig. 1, par. 129), wherein fluid communication between the second flow passageway and the first flow passageway is closed (see par. 103, flow control member, in the form of a dial plug, enables a user to selectively switch between a first state in which flow is enabled between first port 11 and third port 13 via pathway 14 and between third port 13 and second port 12 via second fluid pathway, and a second state in which fluid flow is enabled between the second port 12 and third port 13 via third fluid pathway 16 and par. 115, 129).
Kragelund does not disclose the second container containing a second fluid and allowing the second fluid to flow from the second container into the second spike.
Kraushaar discloses reconstituted substances mixed with diluent can be in powder or concentrated liquid form (see par. 31). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the reconstituted substance in the second container be concentrated liquid form, as Kraushaar discloses reconstituted substances mixed with diluent can be in powder or concentrated liquid form, and this would predictably result in the reconstitution of a substance in order to treat a patient with a concentrated liquid medicament. Consequently, the second fluid would be able to flow form the second container into the second spike (see Kragelund, Figs. 1, 3-4, 7).
Regarding claim 71, Kragelund and Kraushaar disclose the method of claim 70 and Kragelund further discloses the first cavity is dimensions such that the first container unit can only be inserted into the first cavity in a single orientation (see Fig. 7, due to portion 29 of first cavity, the container unit has to be placed with container 2 interacting with spike 30 and container 3 interacting with spike 57).
Claim(s) 72-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kragelund in view of Kraushaar as applied to claim 70 above, and further in view of Radmer.
Regarding claim 72, Kragelund and Kraushaar discloses the limitations of claim 70 but does not disclose inserting a second container unit including a third container containing a third fluid and a fourth container containing a fourth fluid into a second cavity; moving the second container unit from an upper position to a lower position in the second cavity; piercing a stopper of the third container with a third spike disposed in the second cavity; allowing the third fluid to flow from the third container into the third spike, through the first flow passageway, and to the first outlet; piercing a stopper of the fourth container with a fourth spike disposed in the second cavity; and allowing the fourth fluid to flow from the fourth container into the fourth spike, through the second flow passageway, and to the second outlet.
Radmer discloses a drug mixing device having an outlet 17 connected to two containers 5, 21, each of the two containers in a holder for the containers (see Fig. 3, par. 68-69), with multiple holders connected to each other in a series (see Fig. 3) in order to reconstitute from many containers instead of just two (see par. 68). Kragelund discloses a single holder for the first and second container (see Fig. 7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the pooling device of Kragelund contain multiple holders as disclosed by Radmer in order to reconstitute from more than two containers. Consequently, in using the additional holder similar to that of Kragelund, would require inserting a second container unit including a third container containing a third fluid and a fourth container containing a fourth fluid into a second cavity (see rejection of claim 70 describing inserting first container unit); moving the second container unit from an upper position to a lower position in the cavity (see Fig. 7, upper position would be position above but not with spike in septum and lower position would be fully pushed in with spike penetrating septum, like in Fig. 1); piercing a stopper of the third container with a third spike disposed in the second cavity (see Figs. 3, 7, par. 94, 97); allowing the third fluid to flow from the third container into the third spike, through the first flow passageway, and to the first outlet (see Radmer, Fig. 3, containers in series all connected to outlet 17 which would then cause first-fourth containers of Kragelund and Radmer to all be connected to outlet 13 of Kragelund and would flow through outlet 13 to syringe); piercing a stopper of the fourth container with a fourth spike disposed in the second cavity (see Figs. 3, 7, par. 94, 97); and allowing the fourth fluid to flow from the fourth container into the fourth spike through the second flow passageway and to the second outlet (see Radmer, Fig. 3, containers in series all connected to outlet 17 which would then cause first-fourth containers of Kragelund and Radmer to all be connected to outlet 74 of Kragelund due to syringe 20 of reconstituting fluid into container 3 and through second flow passageway and outlet 74).
Regarding claim 73, Kragelund, Kraushaar, and Radmer disclose the limitations of claim 72 but do not disclose the first fluid and the third fluid are both a first type fluid, and wherein the second fluid and the fourth fluid are both a second type fluid, and wherein the first type fluid and the second type fluid are different fluid types.
Radmer discloses the contents of the first container and the third container are the same type, and the contents of the second and the fourth container are the same type, and wherein the first type and the second type are different (see Fig. 3, par. 54-55, 68 same drug in vial 5 of standard size and same liquid in reservoir 21 if plan is to have more of the same type of reconstituted drug). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the first and third container liquid types be the same and the second and fourth container liquid types be the same, as Radmer discloses having the same type of contents for drug reconstitution to create a personal dose out of standard dose vials.
Regarding claim 74, Kragelund, Kraushaar, and Radmer disclose the limitations of claim 72 and as the second holder would have a similar cavity to the first holder in Kragelund, the second cavity would be dimensioned such that the second container unit can only be inserted into the second cavity in a single orientation (see Fig. 7, due to portion 29 of first cavity, the container unit has to be placed with container 2 interacting with spike 30 and container 3 interacting with spike 57).
Claim(s) 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kragelund in view of Kraushaar as applied to claim 70 above, and further in view of Beyer.
Regarding claim 76, Kragelund and Kraushaar disclose the limitations of claim 70 but do not disclose holding the first container in the first cavity with a locking mechanism disposed on an inner wall of the first cavity.
Beyer discloses a container 2 held in a cavity via a locking mechanism 52 disposed on an inner wall of the cavity (see Fig. 2, cl. 19, par. 33, 61). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of Kragelund further include holding the first container via a locking mechanism as disclosed by Beyer to lock the container in place (see Beyer, par. 33).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 57-65, 70-72, and 74-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 52 of U.S. Patent No. 11,219,578, hereinafter ‘578, in view of Kragelund.
Regarding claims 57 and 70, claim 52 of ‘578 discloses substantially all limitations required by claim 57 except for the required except for the required passageways and outlets.
Kragelund discloses a pooling device for pooling a medicinal fluid (see Figs. 1, 3-4, 7), comprising: one or more inlets 124 configured for receiving ambient air (see par. 105); one or more outlets 13, 74 configured for delivering the medicinal fluid to an attachment (see par. 98, 129 port 13 has releasable coupling configuration considered attachment and fluid goes through outlet 74 to get to attachment); a first cavity 11, 12, 29 configured for accommodating insertion of a first container unit 26 having a first container 2 configured to store a first fluid 8 (see par. 93) and a second container 3 configured to store a second fluid (see Fig. 1, container could also store a second fluid), a first spike 30 disposed in the first cavity (see Figs. 3-4, 7) and configured for puncturing a stopper of the first container (see par. 94, 97) when the first container unit transitions from an upper position to a lower position (see Fig. 7, upper position would be position above but not with spike in septum and lower position would be fully pushed in with spike penetrating septum, like in Fig. 1); a second spike 57 (see Fig. 7, par. 110) disposed in the first cavity and configured for puncturing a stopper of the second container when the first container unit transitions from an upper position to a lower position (see Fig. 7, par. 94, 97, upper position would be position above but not with spike in septum and lower position would be fully pushed in with spike penetrating septum, like in Fig. 1); a first flow passageway 14 (see Fig. 1) connected to the first spike and configured to convey the first fluid from the first container to a first outlet 13 of the one or more outlets 13; and a second flow passageway (see Fig. 1, part of passageway 16 separate from passageway 14) separate from the first flow passageway (see Fig. 1), wherein the second flow passageway is connected to the second spike (see Figs. 1, 3-4, 7) and configured to convey the second fluid from the second container to a second outlet 74 of the one or more outlets (see Fig. 1, par. 129), wherein fluid communication between the second flow passageway and the first flow passageway is closed (see par. 103, flow control member, in the form of a dial plug, enables a user to selectively switch between a first state in which flow is enabled between first port 11 and third port 13 via pathway 14 and between third port 13 and second port 12 via second fluid pathway, and a second state in which fluid flow is enabled between the second port 12 and third port 13 via third fluid pathway 16 and par. 115, 129).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add such cavities with related outlets and passageways of Kragelund in order to help with reconstitution of the medicinal fluid.
Regarding claims 58 and 71, Kragelund discloses the first cavity is dimensions such that the first container unit can only be inserted into the first cavity in a single orientation (see Fig. 7, due to portion 29 of first cavity, the container unit has to be placed with container 2 interacting with spike 30 and container 3 interacting with spike 57).
Regarding claims 59 and 72, claim 52 of ‘578 discloses the additional required limitations.
Regarding claim 60, “the first fluid and the third fluid are both a first type fluid, and wherein the second fluid and the fourth fluid are both a second type fluid, and wherein the first type fluid and the second type fluid are different fluid types” are considered function language as the first container units and the second containers units are required to be configured to hold such a fluid, not actually required to hold such a fluid. As the containers of claim 52 are for fluid, they are capable of containing such different fluid types.
Regarding claims 61 and 74, as the second holder would have a similar cavity to the first holder in Kragelund, the second cavity would be dimensioned such that the second container unit can only be inserted into the second cavity in a single orientation (see Fig. 7, due to portion 29 of first cavity, the container unit has to be placed with container 2 interacting with spike 30 and container 3 interacting with spike 57).
Regarding claims 62 and 75, claim 52 of ‘578 discloses this additional limitation.
Regarding claim 63-64, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include an additional cavities and associated additional containers, fluids, outlets, and spikes, as the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), and here the additional cavities and associated parts would be acting similarly to pool and therefore there would be no new and unexpected result.
Regarding claim 65, Kragelund discloses the first spike includes a first channel 32 connected to the one or more inlets and a second channel 31 connected to the first outlet (see Fig. 3).
Claims 66-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 52 of ‘578 in view of Kragelund and further in view of Tachikawa.
Regarding claim 66, Kragelund and claim 52 of ‘578 discloses the limitations of claim 65 but do not disclose a spike sheath connecting the first channel and the second channel in fluid communication when the spike sheath is unpunctured.
Tachikawa discloses a first spike sheath 5 covering a first spike 3 (see Figs. 1-3) such that the tip portion of the spike is spaced from the sheath (see Fig. 2, open space between the tip of the spike and sheath), made of elastic materials such as rubber, and is configured to be punctured (see para. 41) and compressed when the container moves from a position adjacent the spike to a position in which the spike is inside the container (see Fig. 2-3). Tachikawa further discloses the sheath for pollution preventive means of spike 3 (see para. 39-41). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further include a spike sheath such that the tip portion of the spike is spaced from the sheath made of elastic materials such as rubber, and configured to be punctured and compressed when the container moves from a position adjacent the spike to a position in which the spike is inside the container, in order to help prevent pollution of the spike, as disclosed by Tachikawa. Consequently, the space would allow the first and second channels to be in fluid communication.
Regarding claim 67, Kragelund, claim 52 of ‘578, and Tachikawa disclose the limitations of claim 66 and Tachikawa further discloses the spike sheath is configured to be punctured and compressed when the first container unit transitions from the upper position to the lower position (see Figs. 2, 4, when container pushes down to the lower position it would push on sheath and compress while also allowing spike sheath punctured).
Claims 68-69 and 76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 52 of ‘578 in view of Kragelund and further in view of Beyer.
Regarding claim 68, Kragelund and claim 52 discloses the limitations of claim 57 but does not disclose a locking mechanism configured for securely holding the first container unit in the first cavity during use.
Beyer discloses a container 2 held in a cavity via a locking mechanism 52 configured to securely hold the container in the cavity during use (see Fig. 2, cl. 19, par. 33, 61). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device of Kragelund further include a locking mechanism as disclosed by Beyer to lock the container in place (see Beyer, par. 33).
Regarding claim 69, Kragelund, claim 52, and Beyer disclose the limitations of claim 68, and Beyer further discloses the locking mechanism 52 is disposed on an inner wall of the cavity (see Fig. 2), which would be the first cavity as disclosed above in the rejection of claim 57.
Regarding claim 76, Kragelund and claim 52 disclose the limitations of claim 70 but do not disclose holding the first container in the first cavity with a locking mechanism disposed on an inner wall of the first cavity.
Beyer discloses a container 2 held in a cavity via a locking mechanism 52 disposed on an inner wall of the cavity (see Fig. 2, cl. 19, par. 33, 61). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the method of Kragelund and claim 52 further include holding the first container via a locking mechanism as disclosed by Beyer to lock the container in place (see Beyer, par. 33).
Claim 73 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 52 of ‘578 in view of Kragelund and further in view of Radmer.
Regarding claim 73, Kragelund and claim 52 disclose the limitations of claim 72 but do not disclose the first fluid and the third fluid are both a first type fluid, and wherein the second fluid and the fourth fluid are both a second type fluid, and wherein the first type fluid and the second type fluid are different fluid types.
Radmer discloses the contents of the first container and the third container are the same type, and the contents of the second and the fourth container are the same type, and wherein the first type and the second type are different (see Fig. 3, par. 54-55, 68 same drug in vial 5 of standard size and same liquid in reservoir 21 if plan is to have more of the same type of reconstituted drug). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the first and third container liquid types be the same and the second and fourth container liquid types be the same, as Radmer discloses having the same type of contents for drug reconstitution to create a personal dose out of standard dose vials.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781