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 .
Claim Objections
Claims 5, 13 and 23 are objected to because of the following informalities:
Claim 5 recites the limitation “the first means for applying pressure” in last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the first and/or second pressure applicator” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the multi-connector internal diameter” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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.
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.
Claims 1, 3-6, 8-11, 13-15, 17, 19-22, 25, 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Wironen et al. (US 2001/0016703 A1) in view of Ducret et al. (US 2013/0292004 A1), and further in view of McIntosh et al. (US 2006/0253082 A1).
Regarding claim 1, Wironen discloses a process (paragraph 0033) for manufacturing a viscous pharmaceutical formulation in a two chamber apparatus 700 (figure 7) in which a first (chamber inside element 740) and a second chamber (chamber inside element 720) are connected via a multi connector element 710, the process comprising:
(a) loading a gellable material (paragraph 0034, lines 3-5, “paste components” which when combined forms a viscous pharmaceutical substance) into the first chamber
(b) loading a vehicle into the second chamber (paragraph 0034, lines 3-5, “reconstitution fluid”)
(c) transferring (paragraph 0034, lines 11-13) the vehicle from the second chamber to the first chamber, to obtain combined contents,
(e) transferring (paragraph 0034, lines 13-15) the combined contents from the first chamber to the second chamber;
(f) transferring (paragraph 0034, lines 13-17) the combined contents from the second chamber to the first chamber; and
(g) repeating (paragraph 0034, lines 13-17) the transferring (e) and transferring (f) until the combined contents are homogenized
Wironen does not explicitly recite the step of (d) allowing the combined contents to reside in the first chamber for a period of time. However, one can construe the step is inherently taught by Wironen as a time to allow the combined contents to reside in the first chamber for a period of time which can be 1 second before changing the step of moving the combined contents to the second chamber from the first chamber. Alternatively, there will be a small duration of time when the combined contents would stay in the first chamber until all the contents from second chamber has been transferred into the first chamber.
Additionally, Ducret teaches a method for automatically reconstituting drug including the step of allowing the combined contents to reside in the first chamber for a period of time (paragraph 0049) for the purpose of allowing any chemical reactions to conclude prior to continuing to mix or to inject the pharmaceutical composition into the patient (paragraph 0049).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method of Wironen to incorporate the step of allowing the combined contents to reside in the first chamber for a period of time as taught by Ducret for the purpose of allowing any chemical reactions to conclude prior to continuing to mix or to inject the pharmaceutical composition into the patient (paragraph 0049).
Wironen is further silent regarding wherein a CD1/CD2 ratio of a first internal chamber diameter CD1 of the first chamber to a second internal chamber diameter CD2 of the second chamber is greater than 1.
However, McIntosh teaches a design of a fluid dispenser 10 (figure 1) wherein a CD1/CD2 ratio of a first internal chamber diameter CD1 of the first chamber (chamber inside element 24 to a second chamber diameter CD2 of the second chamber (chamber inside element 36) is greater than 1 (paragraph 0042, lines 12-15, when the diameter of first chamber is greater than the diameter of the second chamber, CD1/CD2 would be greater than 1) for the purpose of accommodating larger volume of fluid/component in the first chamber compared to the second chamber when desired (paragraph 0042, lines 12-15).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first and second chambers of Wironen to incorporate wherein a CD1/CD2 ratio of a first internal chamber diameter CD1 of the first chamber to a second internal chamber diameter CD2 of the second chamber is greater than 1 as taught by McIntosh for the purpose of accommodating larger volume of fluid/component in the first chamber compared to the second chamber when desired (paragraph 0042, lines 12-15).
Regarding claim 3, Wironen is silent regarding wherein in the allowing (d), a sufficient amount of time is provided for the vehicle and the gellable material to interact.
However, Ducret teaches wherein in the allowing (d), a sufficient amount of time is provided for the vehicle and the gellable material to interact (paragraph 0049) for the purpose of allowing any chemical reactions to conclude prior to continuing to mix or to inject the pharmaceutical composition into the patient (paragraph 0049).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the method of Wironen to incorporate wherein in the allowing (d), a sufficient amount of time is provided for the vehicle and the gellable material to interact as taught by Ducret for the purpose of allowing any chemical reactions to conclude prior to continuing to mix or to inject the pharmaceutical composition into the patient (paragraph 0049).
Regarding claim 4, Wironen discloses wherein the first chamber comprises a first pressure applicator (plunger mechanism inside element 740) and the second chamber comprises a second pressure applicator (plunger mechanism inside element 720), and
wherein the transferring (paragraph 0034, lines 11-17) of the combined contents from the first chamber to the second chamber and vice versa is performed by means of a reciprocating movement of the first and/or second pressure applicator.
Regarding claim 5, Wironen discloses wherein after step b) and prior to proceeding to step c), the first chamber’s capacity is adjusted (paragraph 0034, lines 7-15, plunger of element 730 is construed as first means for applying pressure alternatively the plunger of element 740 can also be construed as first means since it is pulled prior to completion of step (c)) to a volume approximating or equal to the volume occupied by the vehicle by pressure of the first means for applying pressure.
Regarding claim 6, Wironen discloses wherein the adjustment of the first chamber capacity is assisted by the application of vacuum (paragraph 0034, lines 7-9).
Regarding claim 8, Wironen discloses wherein the first chamber and/or the second chamber is cylindrical (see figure 7).
Regarding claim 9, Wironen discloses wherein the multi-connector element is a valve 710.
Regarding claim 10, Wironen discloses wherein the valve 710 is a three-way valve 710.
Regarding claim 11, Wironen discloses further comprising: an extension tube (see “ET” in figure 7 below), connected to the multi-connector element and the first chamber or to the multi-connector element and the second chamber.
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Regarding claim 13, Wironen discloses wherein the first (plunger of element 740) and/or second (plunger of element 720) pressure applicator is a piston or a plunger (figure 7).
Regarding claim 14, Wironen discloses wherein the gellable material (paragraph 0020) comprises an active pharmaceutical ingredient with one or more gelling properties and/or a pharmaceutical excipient with one or more gelling properties.
Regarding claim 15, Wironen discloses wherein the vehicle comprises a pharmaceutical excipient and/or an active ingredient with no gelling properties (paragraphs 0020, 0021).
Regarding claim 17, Wironen discloses a two-chamber apparatus (figure 7) configured for implementing the process, the apparatus (figure 7) comprising:
(a) the first chamber (chamber inside element 740) configured for holding the gellable material (paragraph 0034, lines 3-5, “paste components” which when combined forms a viscous pharmaceutical substance);
(b) the second chamber (chamber inside element 720) configured for holding the vehicle (paragraph 0034, lines 3-5, “reconstituted fluid”);
(c) the multi-connector element 710 suitable for controlling (paragraph 0034, lines 5-17) passage of the gellable material, the vehicle, air or a mixture thereof from an outlet (opening in chambers of elements 720 or 740) of the first or second chamber, wherein the multi-connector element 710 connects the first chamber (chamber inside element 740) with the second chamber (chamber inside element 720). Wironen is silent regarding wherein the CD1/CD2 ratio is greater than 1.
However, McIntosh teaches wherein the CD1/CD2 ratio is greater than 1 (paragraph 0042, lines 12-15, when the diameter of first chamber is greater than the diameter of the second chamber, CD1/CD2 would be greater than 1) for the purpose of accommodating larger volume of fluid/component in the first chamber compared to the second chamber when desired (paragraph 0042, lines 12-15).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first and second chambers of Wironen to incorporate wherein the CD1/CD2 ratio is greater than 1 as taught by McIntosh for the purpose of accommodating larger volume of fluid/component in the first chamber compared to the second chamber when desired (paragraph 0042, lines 12-15).
Regarding claim 19, Wironen discloses wherein the first chamber comprises a first pressure applicator (plunger mechanism inside element 740) and the second chamber comprises a second pressure applicator (plunger mechanism inside element 720).
Regarding claim 20, Wironen discloses wherein the first and/or second chamber is cylindrical (see figure 7).
Regarding claim 21, Wironen discloses wherein the multi-connector element is a valve 710.
Regarding claim 22, Wironen discloses wherein the valve 710 is a three-way valve 710.
Regarding claim 25, Wironen discloses wherein the first (plunger of element 740) and/or second (plunger of element 720) pressure applicator is a piston or a plunger (figure 7).
Regarding claim 26, Wironen discloses further comprising: vacuum applicator 730 configured to apply a vacuum to the first chamber (paragraph 0034, lines 7-9).
Regarding claim 28, Wironen discloses a product (paragraph 0034), obtained by the process.
Claims 7 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wironen et al. (US 2001/0016703 A1) in view of Ducret et al. (US 2013/0292004 A1), in view of McIntosh et al. (US 2006/0253082 A1) and further in view of Von Isenburg et al. (US 2019/0290690 A1).
Regarding claim 7, Wironen/Ducret/McIntosh (hereinafter referred as “modified Wironen”) discloses the claimed invention substantially as claimed, as set forth above in claims 1, 5 and 6. Modified Wironen is silent regarding wherein the vacuum is applied through a filtration sieve.
However, Von Isenburg teaches a method of preparing the composition wherein the pressure is applied through a filtration sieve (figure 2, “Filter”) for the purpose of maintaining the sterility of the medical apparatus (paragraph 0029).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the method of modified Wironen to include a filtration sieve as taught by Von Isenburg for the purpose of maintaining the sterility of the medical apparatus (paragraph 0029).
Modified Wironen modified in view of Von Isenburg will result in having wherein the vacuum is applied through a filtration sieve because modified Wironen already teaches application of vacuum and Von Isenburg discloses the use of filtration sieve between two syringes establishing pressure-based communication.
Regarding claim 27, modified Wironen discloses the claimed invention substantially as claimed, as set forth above in claims 1, 17, 26 and 27. Modified Wironen is silent regarding wherein the vacuum is applied through a filtration sieve.
However, Von Isenburg teaches a method of preparing the composition wherein the pressure is applied through a filtration sieve (figure 2, “Filter”) for the purpose of maintaining the sterility of the medical apparatus (paragraph 0029).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the method of modified Wironen to include a filtration sieve as taught by Von Isenburg for the purpose of maintaining the sterility of the medical apparatus (paragraph 0029).
Modified Wironen modified in view of Von Isenburg will result in having wherein the vacuum is applied through a filtration sieve because modified Wironen already teaches application of vacuum and Von Isenburg discloses the use of filtration sieve between two syringes establishing pressure-based communication.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wironen et al. (US 2001/0016703 A1) in view of Ducret et al. (US 2013/0292004 A1), in view of McIntosh et al. (US 2006/0253082 A1) and further in view of Hughes (US 2001/0018571 A1).
Regarding claim 12, modified Wironen discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 11. Modified Wironen is silent regarding wherein the extension tube is at least partially made of glass.
However, Hughes teaches a design of a syringe wherein the syringe including the extension tube 24 (figure 2) made of glass (paragraph 0022, lines 15-18) for the purpose of using a well-known material to design the extension tube (paragraph 0022, lines 15-18).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the material of extension tube of modified Wironen to incorporate wherein the extension tube is at least partially made of glass as taught by Hughes for the purpose of using a well-known material to design the extension tube (paragraph 0022, lines 15-18).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wironen et al. (US 2001/0016703 A1) in view of Ducret et al. (US 2013/0292004 A1), in view of McIntosh et al. (US 2006/0253082 A1) and further in view of Montes et al. (US 2013/0079282 A1).
Regarding claim 16, modified Wironen discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Wironen is silent regarding wherein the gellable material is Lanreotide or a pharmaceutically acceptable salt thereof.
However, Montes teaches a process for preparation of pharmaceutical composition (paragraph 0002) wherein the gellable material is Lanreotide or a pharmaceutically acceptable salt thereof for the purpose of preparing an appropriate pharmaceutical composition (paragraph 0003) necessary to treat a desired medical condition.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the gellable material of modified Wironen to incorporate wherein the gellable material is Lanreotide or a pharmaceutically acceptable salt thereof as taught by Montes for the purpose of preparing an appropriate pharmaceutical composition (paragraph 0003) necessary to treat a desired medical condition.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wironen et al. (US 2001/0016703 A1) in view of Ducret et al. (US 2013/0292004 A1), in view of McIntosh et al. (US 2006/0253082 A1) and further in view of Tohse et al. (US 2016/0317799 A1).
Regarding claim 23, modified Wironen discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 17 above. Wironen further discloses further comprising: an extension tube (see “ET” in figure 7 above) with an internal diameter (internal diameter of element “ET” in figure 7 above), connected to the multi-connector element and the first chamber or to the multi-connector element and the second chamber.
Modified Wironen is silent regarding an extension tube with an internal diameter equal to the multi-connector internal diameter.
However, Tohse teaches a design of a syringe with a connector (figure 1) wherein an extension tube 22 with an internal diameter (inner diameter of element 22) equal to the multi-connector internal diameter (internal diameter of element 4, paragraph 0037, lines 31-37) for the purpose of allowing smooth fluid flow by preventing turbulent flow (paragraph 0037, lines 31-37).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify internal diameters of the extension tube and the multi-connector of modified Wironen to incorporate an extension tube with an internal diameter equal to the multi-connector internal diameter as taught by Tohse for the purpose of allowing smooth fluid flow by preventing turbulent flow (paragraph 0037, lines 31-37).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Wironen et al. (US 2001/0016703 A1) in view of Ducret et al. (US 2013/0292004 A1), in view of McIntosh et al. (US 2006/0253082 A1) in view of Tohse et al. (US 2016/0317799 A1) and further in view of Hughes (US 2001/0018571 A1).
Regarding claim 24, modified Wironen/Tohse (hereinafter referred as “modified Wironen ‘03”) discloses the claimed invention substantially as claimed, as set forth above in claims 1, 17 and 23. Modified Wironen ‘03 is silent regarding wherein the extension tube is at least partially made of glass.
However, Hughes teaches a design of a syringe wherein the syringe including the extension tube 24 (figure 2) made of glass (paragraph 0022, lines 15-18) for the purpose of using a well-known material to design the extension tube (paragraph 0022, lines 15-18).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the material of extension tube of modified Wironen ‘03 to incorporate wherein the extension tube is at least partially made of glass as taught by Hughes for the purpose of using a well-known material to design the extension tube (paragraph 0022, lines 15-18).
Allowable Subject Matter
Claim 2 is allowed.
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Wironen et al. (US 2001/0016703 A1) in view of Ducret et al. (US 2013/0292004 A1), and further in view of McIntosh et al. (US 2006/0253082 A1) discloses a process for manufacturing viscous pharmaceutical formulation, the process comprising loading a gellable material in the first chamber, loading a vehicle in the second chamber, transferring the vehicle wherein a ratio of the multi-connector internal diameter to the first internal chamber diameter is in a range, wherein a ratio R2 of the multi-connector internal diameter MCD to the second internal chamber diameter CD2 is in a range but is silent regarding wherein the ratio R1 is never equal to the ratio R2 in combination with other claimed limitations of claim 2.
The closest prior art of record, Wironen et al. (US 2001/0016703 A1) in view of Ducret et al. (US 2013/0292004 A1), and further in view of McIntosh et al. (US 2006/0253082 A1) discloses a two chamber apparatus comprising the first chamber, the second chamber, the multi-connector element wherein a ratio R1 of the multi-connector internal diameter to the first internal chamber diameter is in a range, wherein a ratio R2 of the multi-connector internal diameter MCD to the second internal chamber diameter CD2 is in a range but is silent regarding wherein the ratio R1 is never equal to the ratio R2 in combination with other claimed limitations of claim 18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783