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 .
Response to Amendment
This office action is responsive to the amendment filed on 6/23/2026. As directed by the amendment: claim(s) 3 has been amended. Thus, claims 3-6 and 8-9 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 6/23/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding 112a rejections on page 4:
Applicant's present amendment resolves the preceding office actions stated 112a rejection.
Regarding applicant’s argument regarding claim 3 on page 4-8:
Applicant’s arguments with respect to claim(s) 3, and in particular arguments oriented toward the prior art relied upon for the claimed subject matter of “a barrel having an inner surface … made of cycloolefin polymer (COP) or a cyclo-olefin copolymer (COC)” and “the prefilled syringe is capable of providing a stabilized hydrogen peroxide solution characterized by a residual rate of hydrogen peroxide in the hydrogen peroxide solution of at least 70% after storage at a temperature of 60c for 4 weeks”, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner notes that the examiner's rejection as necessitated by the amendment, below, does rely upon the previously cited prior art of JP 2003093149 A, which provides that a medicated product container containing hydrogen peroxide may have a multitude of layers, including water barrier and oxygen barrier layers, in a certain configuration with at least 1 oxygen barrier layer external to an internal water barrier layer having a surface in contact with the hydrogen peroxide and other contents such that the container has the claimed function of stabilizing the contained hydrogen peroxide.
Examiner further notes that the present claim language states that “the prefilled syringe is capable of providing” this hydrogen peroxide stabilizing function such that if the amalgam of components (e.g. parts, materials, layers, contacting areas, etc.) of the syringe provide this function, then the syringe is considered to provide this function. This present claim language does not limit this function to be solely attributable to a specific component or element of the prefilled syringe. Applicant’s arguments against JP 2003093149 A, appear to regard this specific delineation as to what specific element(s) of the syringe perform this function (i.e. specifically the material of the syringe being capable of providing this function) however, the claimed subject matter is not so narrow, rather the claims only require that the prefilled syringe itself -including its component elements- be capable of performing this function.
Regarding applicant’s argument regarding dependent claims on page 10:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
Claim 3, 5-6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150094689 A1, henceforth written as Steffens, in view of US 20210401895 A1, henceforth written as Jones, and further in view of JP 2003093149 A, henceforth written as Suganuma.
Regarding Claim 3,
Steffens discloses:
A drug delivery device,
(device 10; fig 1)
comprising at least two syringes, wherein at least one of the at least two syringes is a prefilled syringe comprising a barrel having an inner surface filled --
(paragraph 18+25; dual syringes 51 include components of fibrin glue in its chamber (not enumerated) ; fig 1+8)
--and a holder capable of mixing at least two solutions,
(claimed holder comprises the plunger 20, cradle 30, a holster 40, and head 50; fig 1-2)
the holder comprising: a housing section configured to house the at least two syringes,
(cradle 30 and holster 40 encompasses, therein housing, the dual syringes 51; fig 1-5)
a connecting section configured to connect each of the at least two syringes to the holder,
(Paragraph 28; proximal end (not enumerated) of contours 50b connect with dual syringes 51 to join the claimed syringes with head 50; fig 8)
an ejection section configured to eject a mixture comprising the at least two solutions,
(paragraph 28; tip 50c ejects the mixture of the dual syringes 51; fig 8)
and a flow channel in fluid communication with the ejection section and the connecting section,
(paragraph 25 and fig 8 demonstrates that there is a flow pathway between tip 50c and the proximal end (not enumerated) of contours 50b for mixture of the contents of dual syringes 51)
wherein the holder is capable of simultaneously ejecting each solution in the at least two syringes in a fixed ratio.
(paragraph 26; plunger 20 acts on the plunge heads 51b and link the linear translation of both head such that actuation of plunger 20 results in a simultaneous evacuation of the syringe contents, and accordingly does so in a fixed ratio determined by the relative cross-sectional areas of the individual syringes; fig 1-8)
Steffens discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
comprising a barrel having an inner surface filled with a hydrogen peroxide solution
However Jones teaches a distributed media :
[wherein the media is] a hydrogen peroxide solution
(paragraph 816+831; hydrogen peroxide is a broad spectrum antibiotic agent which can be dispensed in vivo to inhibit/eliminate bacteria from multiple major bacterial groups)
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 Jones teachings of dispensed hydrogen peroxide having potent broad spectrum bacterial fighting capabilities to the contents of Steffens disclosed syringes, by disposing hydrogen peroxide in at least one of Steffens syringes, in order to advantageously arrive at an invention which dispenses a potent antibiotic during use that may improve a patient's recovery post-operation by fighting bacteria from multiple major bacterial groups, see paragraph 816 of Jones.
Steffens in view of Jones discloses the elements of the present claim, as described above. Yet, it is still silent on:
and the inner surface is made of cycloolefin polymer (COP) or a cyclo-olefin copolymer (COC); and the prefilled syringe is capable of providing a stabilized hydrogen peroxide solution characterized by a residual rate of hydrogen peroxide in the hydrogen peroxide solution of at least 70% after storage at a temperature of 60"C for a period of time 4 weeks.
However Suganuma teaches a container for solutions containing hydrogen peroxide, where an inner layer of the container in contact with the hydrogen peroxide is formed from a water barrier layer material such as COP/COC, see paragraph 20-21+36-38, and the container can have an intermediary oxygen barrier layer formed from a material such as EVOH, see paragraph 20-21+30-34, such that depending on the oxygen permeability coefficient of the materials of the layers the volatilization and permeation of hydrogen peroxide may be effectively suppressed -or the residual rate of hydrogen peroxide may be maintained at a desirable level- during normal storage conditions (i.e. temperature, humidity, duration of storage, etc.) of the container, see paragraph 12-14+16-19+33-34.
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 container layer material teachings of Suganuma to the syringe barrel disclosed by Steffens as Steffens does not disclose a suitable material construction for such an element and Suganuma teaches that its materials and the layers thereof are suitable for the intended purpose of adequately containing volatile material such as hydrogen peroxide and medical substances, see MPEP 2144.07.
Further at the same time, it would be similarly obvious to routinely optimize the oxygen permeability coefficient of Suganuma’s container layers -particularly its oxygen barrier layer- within the modified invention of Steffens in view of Jones and Suganuma such that during normal storage conditions of a medical delivery device containing volatile elements like hydrogen peroxide, such as the modified device of Steffens in view of Jones and Suganuma, the container continues to suppress the volatilization and permeation of hydrogen peroxide during its normal storage conditions, in order to advantageously arrive at an invention which can maintain volatile contents in an originally manufactured and intended ratio for some amount of time during normal storage conditions, see 16-19+33-34 of Suganuma and MPEP 2144.05.
Regarding claim 5, the modified device of Steffens in view of Jones and Suganuma discloses:
The drug delivery device according to claim 3, further comprising an adapter at the proximal end the drug delivery device,
(Steffens: head 21; fig 3)
wherein each of the at least two syringe is equipped with a plunger rod and,
(Steffens: plunger shaft 51a; fig 8)
the adapter is connected to the plunger rod of each of the at least two syringes.
(Steffens: paragraph 26; U shaped slots 21b 21c mate plunger shafts 51a with head 21; fig 1-8)
Regarding claim 6, the modified device of Steffens in view of Jones and Suganuma discloses:
The drug delivery device according to claim3, wherein each of the at least two syringes is pre-filled with a different desired solution from each other.
(Steffens: paragraph 1-2; dual syringes 51 are filled with distinct components of a fibrin glue composition, fibrinogen and thrombin)
Regarding claim 8, the modified device of Steffens in view of Jones and Suganuma discloses:
A kit comprising the drug delivery device according to claim 3.
(Steffens: paragraph 28+34; device 10 may be accompanied by an air source (not enumerated) , joined via air source fitting 50a, or a hypodermic needle at its tip 50c; fig 8)
Regarding claim 9, the modified device of Steffens in view of Jones and Suganuma discloses:
The kit according to claim 8, wherein each of the at least two syringes is prefilled with a different desired solution from each other.
(Steffens: paragraph 1-2; dual syringes 51 are filled with distinct components of a fibrin glue composition, fibrinogen and thrombin)
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Steffens in view of Jones and Suganuma as applied to claim 3 above, and further in view of US 5376079 A, henceforth written as Holm.
Regarding Claim 4,
Steffens in view of Jones and Suganuma discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Steffens in view of Jones and Kuhnle is silent regarding:
The drug delivery device according to claim 3, wherein cross-sectional areas of filling spaces in each syringe differ from each other.
However, Holm teaches a dual injector:
wherein cross-sectional areas of filling spaces in each syringe differ from each other.
(col 5 line 54 to col 6 line 11 and col 9 line 39-56; syringes with different cross sectional areas when their respective plunger are linearly translated at a same rate, result in different amounts of media distributed for a given distance the plunger travels arriving at a fixed ratio. Accordingly providing different area syringes enables a variation of the mixing ratio of the two media which may be desirable)
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 syringe area differentiation teachings of Holm to the syringes disclosed by Steffens, in order to advantageously arrive at an invention which can mix syringe contents at fixed ratios other than 1:1, as would be desirable for certain types and formulations of a mixed media to be distributed.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly subject matter of the independent claim(s) pertaining to a syringe having certain storage conditions as well as an inner surface comprising COC/COP to contain a solution containing hydrogen peroxide:
US 20190000919 A1
US 20140097144 A1
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
