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 2/25/2026 . 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 10/16/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding claim 3 on page 4-8:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"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 from 0"C to 60"C for a period of time of at least one week."
In this regard applicant particularly argues, that the presently claimed device provides an unexpected stabilizing effect and increased storage stability of hydrogen peroxide as evidence by the example provided in applicant's paragraph 39.
Examiner notes that based on applicant's remarks this alleged unexpected storage/stability result appears as being attributed solely to the specifically claimed materials being in contact with the claimed solution. Applicants provided evidence and arguments do not provide sufficient criticality to the manner that a COC/COP material (i.e. a percent composition, surface thickness, material thickness, material purity, etc.) contributes to the allegedly unexpected improved storage/stability capabilities of the invention, such that it is reasonable to expect that an invention having the claimed structure would be expectedly functionally capable of providing the claimed stability/storage function.
Further, Examiner notes the prior art of JP 2003093149 A, which is not relied upon for the rejection of record, which demonstrates that a container formed from COC/COP forms an oxygen barrier which improves the stability of a solution containing hydrogen peroxide over a storage period.
Thus examiner's preceding and present rejections of record relying upon the prior art of record stands.
Applicant further argues that the prior art of Kuhnle did not teach or suggest, nor recognize or appreciate a device having a prefilled syringe in which the inner surface is made of cycloolefin polymer (COP) or a cyclo-olefin copolymer (COC) and further that Kuhnle did not teach or suggest, nor recognize or appreciate a device having a such an inner surface capable of the previously recited claimed storage/stability function.
Examiner notes that the prior art of Kuhnle is not relied upon for its taught inner coating, rather it is solely relied upon for its teachings that the material of a syringe's body may be made from a transparent plastic like COC or COP. Accordingly, for the reason provided in preceding and present rejection, a person of ordinary skill in the art would be motivated to rely on the teachings of Kuhnle to choose an advantageous material for Steffens syringe, as Steffens syringe does not disclose a specific medically acceptable material of its syringe. Thus, as the modified device does not have an interior coating, as Steffens does not disclose such a structure and Kuhnle is not relied upon for such a structure, the interior surface of the modified device is made of the claimed material. Consequently, for the reasons detailed above, such a modified device would be expectedly and functionally capable of the previously recited claimed storage/stability function.
Regarding applicant’s argument regarding dependent claims on page 8:
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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-6, and 8-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 3
The amended claim recites the following:
“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 from 0"C to 60"C for a period of time of at least one week”, emphasis added.
The original disclosure which is allegedly relied upon for this amendment recites:
“[0038] Stability test of hydrogen peroxide solution Stability test of a hydrogen peroxide solution was performed using a glass yringe, a COP syringe, and a COC syringe. 1 mL of the hydrogen peroxide solution was added to each syringe, sealed, and then stored at 60 *C for 4 weeks. The residual rates of hydrogen peroxide in the hydrogen peroxide solutions after storage were measured. Oxydol "KENEI" (containing 2.5 to 3.5%(w/v) hydrogen peroxide, phosphoric acid and phenacetin) manufactured by Kenei Pharmaceutical Co., Ltd. was used as the hydrogen peroxide solution. The amount of hydrogen peroxide in the hydrogen peroxide solution was detected by titration with a potassium permanganate solution according to oxydol determination method described in the Japanese Pharmacopoeia. [0039] The results are shown in FIG. 2. In the case of the glass syringe, the residual rate of hydrogen peroxide was less than 70%, while the residual rate regarding COP syringe or COC syringe was 70% or more. As a result, the COP syringe and COC syringe were able to suppress the decomposition of hydrogen peroxide more than the glass syringe.”, emphasis added.
Accordingly, it is clear from applicant’s original disclosure that neither the claimed storage temperature range of 0 degrees Celsius to 60 degrees Celsius, nor the claimed stability range of at least 1 week, are supported and thus constitute new matter as the original disclosure does not reasonably convey to a person of ordinary skill in the art that the inventor(s) had possession of the claimed invention at the time of filing.
Regarding claim 4-6 and 8-9
The listed claims are at least rejected for being dependent upon the rejected independent claim 3 incorporating new matter.
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 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 20180133054 A1, henceforth written as Kuhnle, and further in view of US 20210401895 A1, henceforth written as Jones.
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 from 0"C to 60"C for a period of time of at least one week.
However Kuhnle teaches a syringe:
made of cycloolefin polymer (COP) or a cyclo-olefin copolymer (COC);
(paragraph 13+67+76; base body 3, a barrel of syringe 1, is a transparent plastic material such as COP or COC; fig 1)
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 syringe material teaching of Kuhnle to the syringe barrel disclosed by Steffens as Steffens does not disclose a material for such an element, and Kuhnle teaches that this material is suitable for the intended purpose of adequately containing medical media, see MPEP 2144.07, as well advantageously providing means for a user to evaluate the media contained for gross contaminants/defects by the nature of the syringe being transparent, see paragraph 13 of Kuhnle.
Examiner notes that the modified invention of Steffens in view of Jones and Kuhnle provides a prefilled syringe having an inner surface made of COP/COC, such that the COP/COC material of Kuhnle which forms Steffens syringe barrel is in contact with Jones hydrogen peroxide solution also contained in Steffens syringe barrel, such that the modified invention expectedly results in the claimed residual rate of hydrogen peroxide solution after the claimed storage duration and conditions.
Regarding claim 5, the modified device of Steffens in view of Jones and Kuhnle 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 Kuhnle 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 Kuhnle 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 Kuhnle 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 Kuhnle 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 Kuhnle 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 the purported unexpected result of a COC/COP material contributing to the storage stability of a hydrogen peroxide solution contained within the material forming a container:
JP 2003093149 A
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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