DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 2/13/2026. As directed by the amendment: claim 13 has been amended. Thus, claims 1, 3, and 6-13 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 2/13/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the preceding 112b rejection on page 6:
Applicant's present amendment resolves the preceding office actions stated 112b rejection of claim 13.
Regarding applicant’s argument regarding the independent claim on page 7-8:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the present claims:
“a proximal gas volume lying within a volume range having a predetermined minimum value and a predetermined maximum value, -- wherein the predetermined minimum value of the proximal gas volume is 15
μ
L
, and the predetermined maximum volume of the proximal gas volume is 200
μ
L
”
In this regard, applicant argues that the prior art relied upon for these teachings, Lee and its gas volume, has a totally different purpose compared to the gas volume of the present invention such that a person of ordinary skill in the art would not have made the proposed combination. Thus, applicant argues that examiner relies upon impermissible hindsight for the proposed combination of the prior art.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the primary reference of Genese, applicant’s invention, and the teaching references of Lee and Szwarc all contain some air/gas in their contents whose very presence is a risk of introducing a bubble/microbubble into the biological specimen injected into. The pertinent teaching reference of Lee is only relied upon in the present rejection for its teachings of an acceptable injectable gas volume, and not a specific orientation/position of a gas bubble. Lee is explicit in its paragraph 85 that during the use of a conventional prefilled syringe incidental gas bubbles may be introduced intravascularly, and depending on the volume of the bubble introduced the results may be harmless or dangerous to a user. Thus, a person of ordinary skill in the art in possession of the prior art of record would be taught and motivated to make the propose combination in order to arrive at an syringe invention which reduces risks of incidentally introducing a dangerous volume of gas intravascularly, possibly saving a patient’s life.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant also argues that routine optimization of an optimal gas volume range is not so straight forward to a person of ordinary skill in the art on the basis of the disclosure of Lee.
Examiner notes that applicant has not clearly nor specifically presented to examiner the manner by which applicant considers the prior art deficient for performing the recited routine optimization. Examiner noted the in the preceding rejection of record that Lee teaches a gas volume range which sufficiently and substantially overlaps with the claimed range, such that for the detailed reasons, one would be motivated to routinely optimize the volume of gas within the claimed range. See MPEP 2144.05.
Thus, applicant’s arguments are unconvincing and rejection of record presented in the preceding office action, and retained below, stands.
Regarding applicant’s argument regarding dependent claims on page 9:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner’s arguments above detailing the reasons why applicant’s arguments regarding the independent claims are unconvincing, and for at least the rejection of the independent claims the following dependent claims are not presently allowable.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 3, 6-7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 4226236 A, henceforth written as Genese, in view of US 4613326 A, henceforth written as Szwarc, and further in view of US 20120029471 A1, henceforth written as Lee.
Regarding Claim 1,
Genese discloses:
A drug reservoir comprising:
(claimed drug reservoir is comprised of barrel 11 and holder 23; fig 1-4)
a reservoir body extending between an outlet end and a proximal end,
(barrel 11, constituting the claimed reservoir body, with an outlet (not enumerated), shown retaining filter 20, and a proximal end (not enumerated) adjacent the stop surface 59 of barrel 11; fig 1-2)
a front piston arranged in a pre-use position within the reservoir body between the outlet end and the proximal end,
(stopper 51; fig 1-3)
a rear piston arranged within the reservoir body between the front piston and the proximal end,
(stopper 55; fig 1-3)
a distal chamber defined by the outlet end, a first portion of the reservoir body, and the front piston,
(chamber 53; fig 1-2)
the distal chamber holding first contents comprising a distal -- volume,
(solid medicament 54; fig 1-3)
a proximal chamber defined by the front piston, a second portion of the reservoir body, and the rear piston,
(chamber 12; fig 1-2)
the proximal chamber holding second contents comprising a proximal liquid volume,
(liquid diluent 56; fig 1-3)
and a bypass structure allowing fluid flow past the front piston in an advanced position of the front piston in the reservoir body,
(col 3 line 43-59; bypass channel 50 permits diluent 56 to travel from chamber 12 to chamber 53 for mixing with medicament 54; fig 1-3)
wherein the second contents further comprises a proximal gas volume --
(col 1 line 15-16+66-67, col 3 line 48-52 ; air (not enumerated) is disposed within barrel 11, and illustrated as present in chamber 12 and chamber 53 which form barrel 11; fig 1-4)
wherein when the rear piston moves toward the front piston and fluid flows past the front piston via the bypass structure, the proximal chamber collapses before the distal chamber, and --
(fig 1-3, demonstrate the claimed collapsing of chamber 12 prior to chamber 53 to empty the contents of chamber 12 into chamber 53 via bypass channel 50)
Genese discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
-- the distal chamber holding first contents comprising a distal liquid volume, --
However Szwarc teaches a two component medication syringe wherein:
the distal chamber holding first contents comprising a distal liquid volume
(col 8 line 10-12; "second component of medication may be in the form of liquid, liquid soluble powder or combinations thereof"; fig 1-2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the liquid soluble powder medicament disclosed by Genese with a liquid medicament component taught by Szwarc, in order to advantageously at an invention with a more robust number of medicament mixtures which it can mix and dispense for a user, improving the versatility of the invention, as Szwarc demonstrates the solid or liquid state medication components may be considered art recognized equivalents for the same purpose of mixing with other components to create a mixture for subsequent administration, see col 8 line 10-12 of Szwarc and MPEP 2144.06(II),
The modified device of Genese and Szwarc discloses/teaches the elements of the present claim, as described above. Yet, it remains silent regarding:
-- a proximal gas volume lying within a volume range having a predetermined minimum value and a predetermined maximum value, --
--wherein the predetermined minimum value is 15 μL, and the predetermined maximum volume of the proximal gas volume is 200 μL.
However, Lee teaches a two chamber syringe with a volume of gas contained therein along with its medicament components to be mixed:
Lee in paragraph 85 details that the air contained within the syringe is of a similar size to, or smaller than, microbubbles which are of a clinically significant size such that an incidentally injected gas bubble is broken up in a capillary bed of the patient and does not have the same risks associated with a dangerously large volume of gas being injected into a patient. Such small volumes of gas used in conventional syringes to administer medicine can range from 0.01 to 0.1 mL, also written as 10-100 μL.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Lee’s teachings of gas volume within a syringe as a result effective variable determining a syringe’s safety to the modified device of Genese in view of Szwarc by routinely optimizing the unspecified volume of gas in each chamber of Genese, see MPEP 2144.05, such that the claimed proximal and distal chambers each contain the claimed volume range of gas, which paragraph 85 of Lee demonstrates as consistent with a safe injectable gas volume range, in order to advantageously arrives at an invention which reduces the risks associated with air embolism, such as ischemic stroke and death, by containing a safe amount of air in case of operator error in the invention’s venting procedure, or if a failure mode of its filter inhibits gas venting.
Regarding claim 3, the modified device of Genese in view of Szwarc and Lee teaches:
The drug reservoir according to claim 1, wherein the volume range is a predetermined closed volume range from 20 μL to 50 μL.
Lee: (paragraph 85; a safe injectable volume of gas can be .024 mL or 24 μL )
Examiner’s discussion of the combination of Genese in view of Lee above holds that the quantity of gas contained within the syringe is a result effective variable for which it is obvious to routinely modify in order to advantageously arrive at invention which only contains a safe amount of gas which could be injected into a patient.
Regarding Claim 6,
The modified device of Genese in view of Szwarc and Lee discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The drug reservoir according to claim 1, wherein the first contents further comprises a distal gas volume,
(col 1 line 15-16+66-67, col 3 line 48-52 ; air (not enumerated) is disposed within barrel 11, and illustrated as present in chamber 12 and chamber 53 which form barrel 11; fig 1-4)
However, the modified device of Genese in view of Szwarc and Lee is silent regarding:
and wherein the distal gas volume is smaller than the proximal gas volume.
However, Examiner notes that MPEP 2144.04(iv)(a) provides where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform the functions of the prior art device differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Such a modification varying the relative amount of gas in a distal chamber to be vented does not change the manner by which the prior art device of Genese functions as it does not inhibit nor interfere with the venting and/or mixing operation of the invention.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to reduce the amount of gas volume in the distal chamber of the modified device of Genese in view of Szwarc and Lee relative to the amount of gas volume in its proximal chamber, by reducing a quantity of gas to be vented therein improving the time/effort required to prep the syringe for injection and/or raising a volume of the medicament component within the distal chamber such that the distal chamber’s gas volume is reduced and therein facilitating varied proportions of medicament mixtures to be mixed and administered, as such a modification only involving a change in size/proportion of the gas contained in the distal chamber would not perform the medication mixing and administration functions of Genese differently than the prior art device of Genese, see MPEP 2144.04(IV)(A).
Regarding claim 7, Genese discloses:
The drug reservoir according to claim 1, wherein the proximal gas volume comprises air.
(col 1 line 15-16+66-67, col 3 line 48-52 ; air (not enumerated) is disposed within barrel 11; fig 1-4)
Regarding claim 9, Genese discloses:
The drug reservoir according to claim 1, further comprising a hollow needle fixedly arranged at the outlet end and fluidly connected with the distal chamber.
(piercing member 30 pierces filter 20 to fluidically communicate with chamber 53 ; fig 3-4)
Regarding claim 10, Genese discloses:
A drug delivery device comprising:
(syringe 10; fig 1-4)
- a drug reservoir according to claim 1,
(barrel 11; fig 1-4)
See examiner’s modification of elements of the drug reservoir of Genese in view of Szwarc and Lee.
and - a dose expelling structure for pressurising the proximal chamber,
( rod 57 engages stopper 55 to compress, therein pressurize, chamber 12 and chamber 53; fig 1-3)
the dose expelling structure comprising an actuatable piston rod adapted to transfer an expelling force to the rear piston.
(rod 57 engages stopper 55 via their mating projection (not enumerated) and mating cavity (not enumerated) for transferring a force on rod 57 onto stopper 55; fig 1-3)
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Genese in view of Szwarc and Lee as applied to claim 1 above, and further in view of JP 2011067265 A, henceforth written as Ono.
Regarding Claim 8,
The modified device of Genese in view of Szwarc and Lee discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, The modified device of Genese in view of Szwarc and Lee is silent regarding:
The drug reservoir according to claim 1, wherein the proximal gas volume comprises an inert gas.
However, Ono teaches a prefilled syringe
wherein the proximal gas volume comprises an inert gas.
(paragraph 147; "filling the space, an inert gas such as nitrogen gas or argon gas, or a gas (low reactivity gas")
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the inert gas teaching of Ono to the gas volume of the modified device of Genese in view of Szwarc and Lee in order to limit the risk of an active pharmaceutical interacting with an active gas or another active material which may negatively alter or degrade the pharmaceutical to be injected, see paragraph 147.
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Genese in view of Szwarc and Lee as applied to claim 10 above, and further in view of US 11241539 B2, henceforth written as Folk.
Regarding Claim 11,
The modified device of Genese in view of Szwarc and Lee discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, The modified device of Genese in view of Szwarc and Lee is silent regarding:
The drug delivery device according to claim 10, further comprising a housing extending along a reference axis, wherein the dose expelling structure is powered by a spring member operatively coupled with the piston rod and adapted to store energy releasable to urge the piston rod towards the outlet end.
However, Folk teaches an autoinjector
further comprising a housing extending along a reference axis,
(outer casing 310; fig 5)
wherein the dose expelling structure (plunger rod 242 enumerated in fig 3; seen in fig 5) is powered by a spring member (spring 246 enumerated in fig 3; seen in fig 5) operatively coupled with the piston rod
and adapted to store energy releasable to urge the piston rod towards the outlet end.
(col 12 line 65 - col 13 line 8, spring 246 "propel the plunger rod 242 distally D to drive the stopper 226 of the drug storage device 220 through the primary container 222, to expel the drug 228 therefrom and through the dose delivery member 224, thereby delivering the drug 228 to the patient "; fig 4; col 12 line 65 to col 13 line 24, spring 246 releases energy when finger 284 has been disengaged by drive lock mechanism 288, having compressed container spring 392 of locating mechanism 390 and therein locating the drug storage device 320 in an axial injection position primed for subsequent injection; fig 4-5)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement the auto-injecting plunger priming and actuation mechanism taught by Folk to the dose expelling structure disclosed by Genese, by biasing the spring member of Folk and its supporting dose expelling structures against the rod 57 of Genese such that the locating mechanism 390 of Folk may position Genese’s drug reservoir in its injection primed position, where its medicament components are mixed/mixing, prior to initiation of the spring member release mechanism of Folk to inject the mixed medicament of Genese in order to create a device which is usable by lay persons for self-administration, see col 5 line 29-38 of Folk.
Regarding claim 12, the modified device of Genese in view Szwarc, Lee and Folk teaches:
The drug delivery device according to claim 11, further comprising: - a retention structure which when enabled retains the spring member in a tensioned state,
Folk: (plunger lock finger 284 enumerated in fig 3-4; seen in fig 5)
and a sleeve member extending axially along a portion of the housing
Folk: (guard 360 and cylindrical housing of mechanism 288 constitutes the claimed sleeve member; fig 3-5)
and comprising a release structure ,
Folk: (injection drive lock mechanism 288 enumerated in fig 3-4, extending from guard 360; seen in fig 5)
wherein the sleeve member is configured for proximal displacement relative to the housing
Folk: (see fig 3-4, for proximal movement of guard 260, representative of movement of guard 360, relative to outer casing 210, representative of casing 310; fig 5)
and the retention structure from a first position in which the retention structure is enabled to a second position in which the retention structure is disabled by the release structure and stored energy consequently is released from the spring member.
Folk: (see fig 4, for injection drive lock mechanism 288 engaging plunger lock finger 284 to release spring 246)
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 4226236 A, henceforth written as Genese, in view of US 4613326 A, henceforth written as Szwarc, US 20120029471 A1, henceforth written as Lee, US 20180256818 A1, henceforth written as Lumkemann, and JP H07265423 A, henceforth written as Sheguru.
Regarding Claim 13
Genese discloses:
A method of filling a drug reservoir comprising
(claimed drug reservoir is comprised of barrel 11 and holder 23, and is filled with medicament components 54 56; fig 1-4)
a generally cylindrical main body with
(barrel 11; fig 1-4)
a bypass section,
(bypass channel 50; fig 1-4)
a closed outlet end,
(outlet (not enumerated) closed by filter 20; fig 1-4)
and an open end, --
(open end (not enumerated) which receives rod 57; fig 1-4)
(ii) introducing a first -- volume into --a first interior portion of the generally cylindrical main body--
(medicament 54 within barrel 11; fig 1-2)
(iii) -- a first piston into the generally cylindrical main body to a first piston position at least substantially adjoining the free surface of the first -- volume, thereby establishing a front chamber holding the first -- volume,
(stopper 51 is positioned to form chamber 53 in barrel 11; fig 1-3)
(iv) introducing a second liquid volume into the drug reservoir --
(liquid diluent 56; fig 1-3)
(v) -- inserting a second piston into the generally cylindrical main body to a second piston position, thereby establishing a rear chamber, where the second piston position is determined such that the rear chamber holds the second liquid volume and a rear chamber gas volume --
(stopper 55 forms chamber 12 containing diluent 56 and some amount of air to be vented; fig 1-3)
Genese discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
(ii) introducing a first liquid volume into -- a first interior portion of the generally cylindrical main body forming a front chamber
However, Szwarc teaches a method of making a two component medication syringe comprising:
introducing a first liquid volume into the distal interior chamber of a drug reservoir
(col 8 line 10-12; "second component of medication may be in the form of liquid, liquid soluble powder or combinations thereof"; fig 1-2)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the liquid soluble powder medicament disclosed by Genese with a liquid medicament component taught by Szwarc, in order to advantageously at an invention with a more robust number of medicament mixtures which it can mix and dispense for a user, improving the versatility of the invention, as Szwarc demonstrates the solid or liquid state medication components may be considered art recognized equivalents for the same purpose of mixing with other components to create a mixture for subsequent administration, see col 8 line 10-12 of Szwarc and MPEP 2144.06(II),
Notably, Genese of Szwarc remains silent regarding:
a rear chamber gas volume lying within a volume range having a predetermined minimum value and a predetermined maximum value, wherein the predetermined minimum value is 15
μ
L
, and the predetermined maximum volume of the proximal gas volume is 200
μ
L
.
However, Lee teaches a two chamber syringe with a volume of gas contained therein along with its medicament components to be mixed:
Lee in paragraph 85 details that the gas contained within the syringe is of a similar size to, or smaller than, microbubbles which are of a clinically significant size such that an incidentally injected gas bubble is broken up in a capillary bed of the patient and does not have the same risks associated with a dangerously large volume of gas being injected into a patient. Such small volumes of gas used in conventional syringes to administer medicine can range from 0.01 to 0.1 mL, also written as 10-100 μL.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Lee’s teachings of gas volume within a syringe as a result effective variable determining a syringe’s safety to the modified device of Genese in view of Szwarc by routinely optimizing the unspecified volume of gas in each chamber of Genese, see MPEP 2144.05, such that the claimed proximal and distal chambers each contain the claimed volume range of gas, which paragraph 85 of Lee demonstrates as consistent with a safe injectable gas volume range, in order to advantageously arrives at an invention which reduces the risks associated with air embolism, such as ischemic stroke and death, by containing a safe amount of air in case of operator error in the invention’s venting procedure, or if a failure mode of its filter inhibits gas venting.
Notably, Genese in view of Szwarc and Lee remains silent regarding:
(ii) introducing a first liquid volume into the drug reservoir through the open end such that a first interior portion of the generally cylindrical main body, including the bypass section, is covered by liquid in a vertical position of the drug reservoir where the open end faces upward,
However, Examiner notes that MPEP 2144.04(iv)(a) provides where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform the functions of the prior art device differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Accordingly, such a modification involving increasing a relative proportion of distal medicament such that it encompasses a greater volume of chamber 53, and therein overlaps with bypass channel 50 when device 10 is vertically arranged, does not interfere with or inhibit the prior art device of Genese’s operation of venting gas and mixing medication components together before injection.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to increase the proportion of first liquid volume in the drug reservoir of Genese relative to the drug reservoir front chamber of Genese, such that an amount of the first liquid volume overlaps with the bypass channel 50, as such a modification would not perform the prior art functions of Genese differently and would advantageously arrive at an invention which can facilitate the mixing and consequent dispensing of multi-component medicament mixtures which require greater proportions of one medicament relative to another, see MPEP 2144.04(IV)(A).
Notably, Genese in view of Szwarc and Lee remains silent regarding, as Genese does not disclose a method for manufacturing its invention:
the method comprising: (i) arranging the drug reservoir at least substantially vertically with the open end facing upward,
(ii) introducing a first liquid volume into the drug reservoir through the open end
(iii) -- inserting a first piston into the generally cylindrical main body to a first piston position -- establishing a front chamber holding the first liquid volume
(iv) introducing a second liquid volume into the drug reservoir through the open end, and
(v) -- inserting a second piston into the generally cylindrical main body to a second piston position, thereby establishing a rear chamber,
However Lumkemann teaches a method of filling a multi-chamber syringe:
the method comprising: (i) arranging the drug reservoir at least substantially vertically with the open end facing upward,
(see fig 5 and paragraph 60-61 demonstrating the vertical orientation of syringe 19 for filling)
(ii) introducing a first liquid volume into the drug reservoir through the open end
(first pharmaceutical liquid 79 positioned in syringe 19 via the upper proximal end side 229; fig 5A-B)
(iii) -- inserting a first piston into the generally cylindrical main body to a first piston position -- establishing a front chamber holding the first liquid volume
(middle plunger 39 forms a distal chamber 249 containing liquid 79; fig 5)
(iv) introducing a second liquid volume into the drug reservoir through the open end, and
(second pharmaceutical liquid 89 positioned in syringe 19 via the upper proximal end side 229; fig 5C-D)
(v) -- inserting a second piston into the generally cylindrical main body to a second piston position, thereby establishing a rear chamber,
(end plunger 49 forming a proximal chamber 259; fig 5D-E)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to construct the modified device of Genese in view of Szwarc and Lee by implementing Lumkemann’s teachings method of filling a multichamber syringe multiple stoppers and a bypass for mixing liquid medicament components, in order to advantageously arrive at an application of a known technique for filling and assembling multi-chamber syringes that is applicable to the invention of Genese to arrive at the predictable result of a method of manufacturing the modified device, see MPEP 2143(I)(D).
Notably, Genese in view of Szwarc, Lee, and Lumkemann remains silent regarding:
in a -- sub-atmospheric pressure environment inserting a -- piston into the generally cylindrical main body to a -- piston position
Sheguru teaches a method of filling a double chamber syringe
in a -- sub-atmospheric pressure environment inserting a -- piston into the generally cylindrical main body to a -- piston position
(paragraph 8+ 10+18-19 +27; method of filling includes use of vacuum pressure, therein sub-atmospheric, environment for supporting placement of piston by adjusting the relative pressure of the environment relative to the pressure within the syringe for setting an accurate position of the plunger in the syringe and forming a component containing chamber)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sub-atmospheric pressure environment syringe chamber gas volume taught by Sheguru to the method of filling a multi-chamber syringe disclosed/taught by the modifidied invention of Genese in view of Szwarc, Lee, and Lumkemann, by repeating the environmental pressure variation procedure of Sheguru for each of Genese’s stoppers, in order to reliably stop the piston in a predetermined position, see paragraph 10+29 of Sheguru, and consequently arrive at an advantageous invention which has a more reliable means for setting the total volume of each of its medicament component containing chambers.
As Sheguru's piston positioning involves breaking of a sub-atmospheric pressure environment to position the first gasket 4, in order to apply this teaching in a manner to reliably position both pistons of Genese as noted in the modification/motivations statement above, there would therein be a subsequent second sub-atmospheric pressure environment to support reliably placing the second piston.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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