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 1/26/2026. As directed by the amendment: claims 1, 11, and 17 have been amended. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding allegations of new matter on page 5-6:
Applicant argues that paragraph 45 of applicant’s disclosure provides adequate support for the claim language of “the barrel and all of the tip being formed from one of a glass and a polymer that does not absorb liquid” because applicant alleges that the disclosure’s recitation that the barrel and syringe tip being integrally formed from a same material, wherein that material may be “any suitable material”, inherently discloses that that material would not be absorbent.
Examiner notes that the broad recitation of “any suitable material” does not permit applicant to fabricate allegedly inherent characteristics of that material to produce a much more narrow set of claimed subject matter. MPEP 2163.07(a) states that “By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it. The application may later be amended to recite the function, theory or advantage without introducing prohibited new matter”. However, to establish inherency of this feature applicant’s disclosure must make clear that this allegedly inherent feature of the material is necessarily present, would be recognized by a person of ordinary skill in the art, and importantly this cannot be established with mere probabilities or possibilities.
Examiner notes that applicant’s originally filed disclosure does not make clear that the material forming the syringe barrel and tip be a nonabsorbent material as the originally filed disclosure does not provide any discussion of permeability or non-permeability of the disclosed elements. Further applicants’ arguments that if the barrel/tip of the syringe “were made from an absorbent material, the therapeutic product absorbed by the tip or barrel could not be dispensed by the movement of the plunger-stopper, resulting a waste of therapeutic product”. This is merely a probability or possible outcome of a syringe barrel/tip being formed from an absorbent material, and selectively ignores all other considerations of glass/polymer materials being absorbent to liquid, such as an actuation of a plunger/piston at a rate/force relative to a syringe tip lumen flow resistance and material absorptivity/liquid-permeability coefficient such that a liquid follows a path of least resistance out of a syringe tip as opposed to a liquid absorbable material, a material being selectively permeable to certain liquids such as hydrogen peroxide, glutaraldehyde, and other sterilizing liquids which have distinct molecular weights relative to other liquids which may be readily permeable in certain materials, and inventions being formed of layered materials having simultaneously absorptive and non-absorptive qualities.
Accordingly, for the reasons state above and provided in examiner’s 112a rejection of the claims, below, the amendments to the claims do constitute new matter.
Regarding applicant’s argument regarding the independent claims on page 6-7:
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 barrel and all of the tip being formed from one of a glass and a polymer that does not absorb liquid”
Applicant’s arguments with respect to the independent claim(s) newly amended claim language 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.
Regarding applicant’s argument regarding dependent claims on page 7:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, 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 1-20 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 claims 1, 11, and 17
The claims recite claim language of “the barrel and all of the tip being formed from one of a glass and a polymer that does not absorb liquid”, however applicant’s disclosure is silent regarding the specific type of glass and polymer forming the elements of the syringe as being a type of material which does not absorb liquid. Nor from the disclosure, the facts of record, or to the understanding of a person of ordinary skill in the art is this an inherent characteristics of these materials. Accordingly, the claims constitute new matter as the claim 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 at the time the application was filed had possession of the claimed invention.
Regarding claim 2-10, 12-16, and 18-20,
The claims are at least rejected for being dependent form and thus incorporating the new subject matter of the independent claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12
The claim recites “mounting a tip cap assembly on the tip--mounting a tip cap assembly having an insert with a skirt on at least a portion of the tip”, rendering the claim indefinite as it is unclear whether the step of mounting a tip cap assembly on a portion of the tip is pertaining the precedingly claimed tip cap assembly, or is instead referring to a new distinct tip cap assembly. For examination purposes to be interpreted as referring to the same tip cap assembly in light of applicant’s disclosure fig 2.
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.
Claims 1, 3-7, 11, 13-14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 5395339 A, henceforth written as Talonn, in view of US 20160184571 A1, henceforth written as Admati, in view of US 20200147254 A1, henceforth written as Lombardia, and in view of US 20200269033 A1, henceforth written as Corrigan.
Regarding Claim 1,
Talonn discloses:
A syringe sterilization verification assembly comprising:
(col 5 line 49 to col 6 line 7; syringe assembly 10 is to be sterilized; fig 1)
a syringe
(sterile syringe 12; fig 1)
defining a barrel integrally formed with a tip, all of the tip being unitary with the barrel, --
(col 5 line 49 to col 6 line 7; luer tip 26 on luer skirt 28 extends from barrel 16; fig 1-3 demonstrating the unitary formation of tip 26 and skirt 28 with barrel 16)
--a tip cap assembly including an insert having a skirt configured to receive the tip;
(col 7 line 1-32; needle assembly 14, considered the tip cap assembly includes hub 54, considered the claimed skirt, which receives tip 26; fig 1-2)
and [a portion of the invention disposed] around at least a portion of the tip and disposed radially between the tip and the skirt of the insert [is intended to be sterile]
(col 7 line 42 to col 8 line 8; a primary area which needs to be protected against contamination, therein an area which must be assured of adequate sterilization, is the "distal barrier" of the invention which includes the luer tip 26 on skirt 28 on barrel 16, needle 50, and needle sheath 48)
Talonn discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the barrel and all of the tip being formed [from a material such as] one of a glass and a polymer that does not absorb liquid;
However Admati teaches a syringe with a cap intended to be maintained in a sterile state comprising:
Syringe and syringe barrel being formed from one of a glass and a polymer that does not absorb liquid;
(paragraph 2+38+44; syringe 12, inclusive of its tip, are demonstrated in fig 2 as being integrally formed, and are formed from a liquid-impermeable polymer or glass; fig 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 implement the syringe material teachings of Admati into the invention of Talonn, such that Talonn’s syringe 12 and its tip 26 are formed from Admati’s polymer/glass material, in order to advantageously arrive at an invention with materials which provide a sufficiently low level of permeability to liquid solutions such that the invention’s ability to store liquid solutions for an extended period is improved, see paragraph 44 of Admati.
Talonn in view of Admati discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
and a biological indicator (BI) member [being disposed with the invention]
However Lombardia teaches a biological indicator of sterilization effectiveness:
a biological indicator (BI) member [disposed relative to an element/environment needing to be assured of sterilization/being free of contamination]
(abstract + paragraph 45-51+56-57; an indicator, disposed on a carrier having any three-dimensional shape, produces a volumetric indicia of sterilization in a closed environment/on a surface because a substance/reagent retained by the carrier reacts to a sterilizing agent and produces a visible property which indicates a sterilization as occurred there; fig 1-9)
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 apply Lombardia's system and method for verifying a sterilization procedure to Talonn's disclosure of syringe assembly to be sterilized, by disposing a three-dimensional carrier/indicator of Lombardia in at least a part of one of the primary contamination-free areas informed by Talonn, therein arriving at part of the claimed invention having a biological indicator adjacent the claimed tip, in order to advantageously apply a known technique of verifying sterilization methods to a known medical device requiring sterilization, and particularly a known area of a device requiring sterilization assurance, to yield the predicable result of an invention which can assure that a sterilization method has adequately reached a high contamination risk area, see MPEP 2143(I)(D), paragraph 45-51+57 of Lombardia, and col 7 line 42 to col 8 line 8 of Talonn.
Talonn in view of Admati and Lombardia discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a [shape of a ] biological indicator (BI) member having an annular portion disposed around at least a portion of the tip and disposed radially between the tip and the skirt of the insert.
Notably, Lombardia does teach in paragraph 46+48+56-57 that its biological indicator member may be of a geometrical shape which is suitable to be positioned within an environment/against a surface which is a critical area to be assured has been adequately sterilized/disinfected.
However Corrigan teaches a sterilization system for luer devices comprising:
a shape of a [member contributing to the decontamination of a luer device] having an annular portion disposed around at least a portion of the tip and disposed radially between the tip and the skirt of the insert.
(paragraph 48-57; cover 120 has a base 122 – therein an portion disposed on a tip face 154 of a male taper fitting 152 – and a sidewall 130 – therein a portion disposed radially against a side surface 156 of male taper fitting 152 – which are disposed in an area around male taper fitting 152 which is critical to be assured is disinfected/sterilized, such that cover 120 can be considered an element critical to confirming the sterility of portions of a male taper mating device; fig 1-4 illustrate the positional relationship of cover 120 relative to elements of male taper fitting 152 and further the annular shape of cover 120)
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 implement Corrigan’s teachings of a shape of an element intended to cover an area of a tapered surface to be assured of sterilization to the biological indicator member of the modified invention of Talonn in view of Admati and Lombardia, such that Lombardia’s carrier & indicator disposed in the distal barrier of Talonn is shaped with an annular distal face and proximally extending sidewalls to mate with the distal face and tapered sidewall of Talonn’s tip 26, in order to advantageously arrive at an invention with a biological indicator which conforms to the shape of a tapered surface to be assured of sterilization, see paragraph 56-57 of Lombardia and paragraph 49-50 & fig 3 of Corrigan.
Regarding claim 3, the modified invention of of Talonn in view of Admati, Lombardia, and Corrigan discloses:
The syringe sterilization verification assembly of claim 1, wherein the annular portion of the BI member has an elongated sleeve-like shape with a frusto-conical configuration complementary to a configuration of the tip of the barrel, wherein the tip is tapered.
Examiner notes that in light of the modification of Talonn in view of Admati, Lombardia, and Corrigan made above, the BI member of Lombardia is shaped with a distal face and proximally extending members so as to be annular, relatively cylindrical, and forming an tapered elongated sleeve-shape to mate with the tapered surface of Talonn’s tip 26. The shape of Lombardia’s BI member is best illustrated in Corrigan’s fig 1-3. The tapered shape of Talonn’s tip 26 is best illustrated in Talonn’s fig 1-3.
Regarding claim 4, the modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses:
The syringe sterilization verification assembly of claim 3, wherein the tip of the barrel defines a channel receiving the BI member.
See examiner’s annotation of Talonn’s fig 1, delineating the aspects of the prior art considered to be a channel which receives the BI member of Lombardia, incorporated in the modification of the prior art made in claim 1 above.
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Regarding claim 5, the modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses:
The syringe sterilization verification assembly of claim 1, wherein a proximal end of the BI member extends to a location external to a connection between the skirt and the tip of the barrel such that the proximal end of the BI member is not disposed radially between the tip and the skirt of the insert.
Examiner notes that in light of the modification of Talonn in view of Admati, Lombardia, and Corrigan made above, the BI member of Lombardia is shaped with a planar face, see the shape of Corrigan’s base 122 in fig 1+3-4, and is disposed in the claimed configuration against a face of Talonn’s tip 26, such that the planar face of the BI member of modified invention is external to the mating, therein connection, of the sidewall of Talonn’s tip 26 and the sidewall of Talonn’s hub 54, the skirt of the insert.
Regarding claim 6, the modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses:
The syringe sterilization verification assembly of claim 1, wherein the BI member extends 360 degrees around the tip of the barrel.
Examiner notes that in light of the modification of Talonn in view of Admati, Lombardia, and Corrigan made above, the BI member of Lombardia is shaped such that it extends circumferentially, therein 360 degrees, around the tip 26 of Talonn’s claimed barrel. This shape is best illustrated in Corrigan’s fig 1-4.
Regarding Claim 7,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, the modified invention of Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
wherein the BI member comprises an axial dimension that is less than an axial dimension of the tip.
However, MPEP 2144.04(V)(B) 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 differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Such a modification of the sidewalls of the BI member some amount shorter than the tip of the syringe, such that BI member has an axial dimension less than an axial dimension of the tip would not arrive at a modified invention which performs the recited functions of the prior art differently than its disclosed present embodiment.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to shorten the BI member sidewalls taught by the modified invention of Talonn in view of Lombardia and Corrigan relative to the tip disclosed by Talonn, therein arriving at the claimed subject matter, as such a modification decreasing the relative proportion of the claim elements would only involve routine skill in the art , see MPEP 2144.04(IV)(A), and would not alter the performance of the prior art for its disclosed function(s).
Regarding Claim 11,
Talonn discloses:
the method comprising: providing a syringe
(col 5 line 49 to col 6 line 7; syringe 12 of syringe assembly 10 is to be sterilized; fig 1)
defining a barrel integrally formed with a tip, all of the tip being unitary with the barrel, --
(col 5 line 49 to col 6 line 7; luer tip 26 on luer skirt 28 extends from barrel 16; fig 1-3 demonstrating the unitary formation of tip 26 and skirt 28 with barrel 16)
--mounting a tip cap assembly on the tip; -- mounting a tip cap assembly having an insert with a skirt on at least a portion of the tip,
(col 7 line 1-32; needle assembly 14, considered the tip cap assembly includes hub 54, considered the claimed skirt, which receives tip 26; fig 1-2)
the skirt having a cavity sized to receive the tip therein, --
(fig 2 best illustrate hub 54’s cavity receiving tip 26)
wherein mounting the tip cap assembly on the tip causes [a portion of the invention] to be disposed radially between the skirt of the insert and the tip and [is intended to be sterile]
(col 7 line 42 to col 8 line 8; a primary area which needs to be protected against contamination, therein an area which must be assured of adequate sterilization, is the "distal barrier" of the invention which includes the luer tip 26 on skirt 28 on barrel 16, needle 50, and needle sheath 48)
--subjecting the syringe and tip cap assembly to a sterilization process;
(col 5 line 49-53; syringe assembly 10 is sterile, therein was subjected to a sterilization process)
Talonn discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the barrel and all of the tip being formed [from a material such as] one of a glass and a polymer that does not absorb liquid;
However Admati teaches a syringe with a cap intended to be maintained in a sterile state comprising:
Syringe and syringe barrel being formed from one of a glass and a polymer that does not absorb liquid;
(paragraph 2+38+44; syringe 12, inclusive of its tip, are demonstrated in fig 2 as being integrally formed, and are formed from a liquid-impermeable polymer or glass; fig 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 implement the syringe material teachings of Admati into the invention of Talonn, such that Talonn’s syringe 12 and its tip 26 are formed from Admati’s polymer/glass material, in order to advantageously arrive at an invention with materials which provide a sufficiently low level of permeability to liquid solutions such that the invention’s ability to store liquid solutions for an extended period is improved, see paragraph 44 of Admati.
Talonn in view of Admati discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
A method for verifying sterilization, comprising: a biological indicator (BI) member [being disposed with the invention] and subjecting the [invention] and the BI member to a sterilization process; and testing the BI member for sterilization.
However Lombardia teaches a biological indicator of sterilization effectiveness:
A method for verifying sterilization, comprising: a biological indicator (BI) member [disposed relative to an element/environment needing to be assured of sterilization/being free of contamination]
(abstract + paragraph 45-51+56-57; an indicator, disposed on a carrier having any three-dimensional shape, produces a volumetric indicia of sterilization in a closed environment/on a surface because a substance/reagent retained by the carrier reacts to a sterilizing agent and produces a visible property which indicates a sterilization as occurred there; fig 1-9)
and subjecting the [invention] and the BI member to a sterilization process; and testing the BI member for sterilization.
(paragraph 14+55-60+67-70; the indicator disposed on a carrier is subjected to a sterilization process, such that the indicator reacts with the sterilizing agents to produce a change of color which indicates an efficacy of a sterilization process)
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 apply Lombardia's system and method for verifying a sterilization procedure to Talonn's disclosure of syringe assembly to be sterilized, by disposing a three-dimensional carrier/indicator of Lombardia in at least a part of one of the primary contamination-free areas informed by Talonn, therein arriving at part of the claimed invention having a biological indicator adjacent the claimed tip, in order to advantageously apply a known technique of verifying sterilization methods to a known medical device requiring sterilization, and particularly a known area of a device requiring sterilization assurance, to yield the predicable result of an invention which can assure that a sterilization method has adequately reached a high contamination risk area, see MPEP 2143(I)(D), paragraph 45-51+57 of Lombardia, and col 7 line 42 to col 8 line 8 of Talonn.
Talonn in view of Admati and Lombardia discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
[a biological indicator (BI) member shaped to dispose] an annular portion of a biological indicator (BI) member around the tip, wherein mounting the tip cap assembly on the tip causes the annular portion of the BI member to be disposed radially between the skirt of the insert and the tip;
Notably, Lombardia does teach in paragraph 46+48+56-57 that its biological indicator member may be of a geometrical shape which is suitable to be positioned within an environment/against a surface which is a critical area to be assured has been adequately sterilized/disinfected.
However Corrigan teaches a sterilization system for luer devices comprising:
[a biological indicator (BI) member shaped to dispose] an annular portion of a biological indicator (BI) member around the tip, wherein mounting the tip cap assembly on the tip causes the annular portion of the BI member to be disposed radially between the skirt of the insert and the tip;
(paragraph 48-57; cover 120 has a base 122 – therein an portion disposed on a tip face 154 of a male taper fitting 152 – and a sidewall 130 – therein a portion disposed radially against a side surface 156 of male taper fitting 152 – which are disposed in an area around male taper fitting 152 which is critical to be assured is disinfected/sterilized, such that cover 120 can be considered an element critical to confirming the sterility of portions of a male taper mating device; fig 1-4 illustrate the positional relationship of cover 120 relative to elements of male taper fitting 152, the annular shape of cover 120, and further the disposal of cover 120 between a male luer taper fitting 152 and a skirt of cap 104)
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 implement Corrigan’s teachings of a shape of an element intended to cover an area of a tapered surface to be assured of sterilization to the biological indicator member of the modified invention of Talonn in view of Admati and Lombardia, such that Lombardia’s carrier & indicator disposed in the distal barrier of Talonn is shaped with an annular distal face and proximally extending sidewalls to mate with the distal face and tapered sidewall of Talonn’s tip 26, in order to advantageously arrive at an invention with a biological indicator which conforms to the shape of a tapered surface to be assured of sterilization, see paragraph 56-57 of Lombardia and paragraph 49-50 & fig 3 of Corrigan.
Regarding claim 13, the modified invention of of Talonn in view of Admati, Lombardia, and Corrigan discloses:
The method of claim 11, wherein disposing the annular portion of the BI member around at least a portion of the tip comprises disposing a BI member having an elongated sleeve-like shape with a frusto-conical configuration on the tip.
Examiner notes that in light of the modification of Talonn in view of Admati, Lombardia, and Corrigan made above, the BI member of Lombardia is shaped with a distal face and proximally extending members so as to be annular, relatively cylindrical, and forming an tapered elongated sleeve-shape to mate with the tapered surface of Talonn’s tip 26. The shape of Lombardia’s BI member is best illustrated in Corrigan’s fig 1-3. The tapered shape of Talonn’s tip 26 is best illustrated in Talonn’s fig 1-3.
Regarding claim 14, the modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses:
The method of claim 13, further comprising disposing the BI member into a channel on the tip.
See examiner’s annotation of Talonn’s fig 1, delineating the aspects of the prior art considered to be a channel which receives the BI member of Lombardia, incorporated in the modification of the prior art made in claim 1 above.
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Regarding Claim 17,
Talonn discloses:
the method comprising: providing a syringe
(col 5 line 49 to col 6 line 7; syringe 12 of syringe assembly 10 is to be sterilized; fig 1)
defining a barrel integrally formed with a tip, all of the tip being unitary with the barrel, --
(col 5 line 49 to col 6 line 7; luer tip 26 on luer skirt 28 extends from barrel 16; fig 1-3 demonstrating the unitary formation of tip 26 and skirt 28 with barrel 16)
--mounting a tip cap assembly on the tip, the tip cap assembly having an insert with a skirt having a cavity to receive the tip therein;
(col 7 line 1-32; needle assembly 14, considered the tip cap assembly includes hub 54, considered the claimed skirt, which receives tip 26; fig 1-2 best illustrate the cavity of hub 54 receiving tip 26)
the skirt having a cavity sized to receive the tip therein, --
(fig 2 best illustrate hub 54’s cavity receiving tip 26)
-- an interface between the insert and the tip;
(col 7 line 42 to col 8 line 8; a primary area which needs to be protected against contamination, therein an area which must be assured of adequate sterilization, is the "distal barrier" of the invention which includes the luer tip 26 on skirt 28 on barrel 16, needle 50, and needle sheath 48)
subjecting the syringe and tip cap assembly to a sterilization process; --
(col 5 line 49-53; syringe assembly 10 is sterile, therein was subjected to a sterilization process)
Talonn discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the barrel and all of the tip being formed [a material such as] one of a glass and a polymer that does not absorb liquid;
However Admati teaches a syringe with a cap intended to be maintained in a sterile state comprising:
Syringe and syringe barrel being formed from one of a glass and a polymer that does not absorb liquid;
(paragraph 2+38+44; syringe 12, inclusive of its tip, are demonstrated in fig 2 as being integrally formed, and are formed from a liquid-impermeable polymer or glass; fig 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 implement the syringe material teachings of Admati into the invention of Talonn, such that Talonn’s syringe 12 and its tip 26 are formed from Admati’s polymer/glass material, in order to advantageously arrive at an invention with materials which provide a sufficiently low level of permeability to liquid solutions such that the invention’s ability to store liquid solutions for an extended period is improved, see paragraph 44 of Admati.
Talonn in view of Admati discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
A method for verifying sterilization, comprising: a biological indicator (BI) member [being disposed with the invention]; inoculating a BI member; subjecting the [invention] to a sterilization process; and testing the [invention] for sterilization.
However Lombardia teaches a biological indicator of sterilization effectiveness:
A method for verifying sterilization, comprising: a biological indicator (BI) member [disposed relative to an element/environment needing to be assured of sterilization/being free of contamination]
(abstract + paragraph 45-51+56-57; an indicator, disposed on a carrier having any three-dimensional shape, produces a volumetric indicia of sterilization in a closed environment/on a surface because a substance/reagent retained by the carrier, therein an interface inoculated with the substance/reagent, reacts to a sterilizing agent and produces a visible property which indicates a sterilization as occurred there; fig 1-9)
and subjecting the [invention] and the BI member to a sterilization process; and testing the BI member for sterilization.
(paragraph 14+55-60+67-70; the indicator disposed on a carrier is subjected to a sterilization process, such that the indicator reacts with the sterilizing agents to produce a change of color which indicates an efficacy of a sterilization process)
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 apply Lombardia's system and method for verifying a sterilization procedure to Talonn's disclosure of syringe assembly to be sterilized, by disposing a three-dimensional carrier/indicator of Lombardia in at least a part of one of the primary contamination-free areas informed by Talonn, therein arriving at part of the claimed invention having a biological indicator adjacent the claimed tip, in order to advantageously apply a known technique of verifying sterilization methods to a known medical device requiring sterilization, and particularly a known area of a device requiring sterilization assurance, to yield the predicable result of an invention which can assure that a sterilization method has adequately reached a high contamination risk area, see MPEP 2143(I)(D), paragraph 45-51+57 of Lombardia, and col 7 line 42 to col 8 line 8 of Talonn.
Talonn in view of Admati and Lombardia discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
[an inoculated interface, associated with sterilization] between the insert and the tip
Notably, Lombardia does teach in paragraph 46+48+56-57 that its biological indicator member may be of a geometrical shape which is suitable to be positioned within an environment/against a surface which is a critical area to be assured has been adequately sterilized/disinfected.
However Corrigan teaches a sterilization system for luer devices comprising:
[a biological indicator (BI) member shaped to be disposed] between a cap element and a male luer tip
(paragraph 48-57; cover 120 has a base 122 – therein an portion disposed on a tip face 154 of a male taper fitting 152 – and a sidewall 130 – therein a portion disposed radially against a side surface 156 of male taper fitting 152 – which are disposed in an area around male taper fitting 152 which is critical to be assured is disinfected/sterilized, such that cover 120 can be considered an element critical to confirming the sterility of portions of a male taper mating device; fig 1-4 illustrate the positional relationship of cover 120 relative to elements of male taper fitting 152, the annular shape of cover 120, and further the disposal of cover 120 between a male luer taper fitting 152 and a skirt of cap 104)
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 implement Corrigan’s teachings of a shape of an element intended to cover an area of a tapered surface to be assured of sterilization to the biological indicator member of the modified invention of Talonn in view of Admati and Lombardia, such that Lombardia’s carrier & indicator disposed in the distal barrier of Talonn is shaped with an annular distal face and proximally extending sidewalls to mate with the distal face and tapered sidewall of Talonn’s tip 26, in order to advantageously arrive at an invention with a biological indicator which conforms to the shape of a tapered surface to be assured of sterilization, see paragraph 56-57 of Lombardia and paragraph 49-50 & fig 3 of Corrigan.
Claim(s) 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over of Talonn in view of Admati, Lombardia, and Corrigan as applied to claims above, and further in view of US 20170175163 A1, henceforth written as Ahimou.
Regarding Claim 2,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan 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 syringe sterilization verification assembly of claim 1, wherein the annular portion of the BI member comprises a wire member
Examiner notes in light of the modification of Talonn in view of Admati, Lombardia, and Corrigan made above, the BI member of Lombardia resembles the shape of Corrigan’s cover 120, its base 122, and its sidewalls 130, such that the claimed BI member has a base and extending sidewalls, and the extending sidewall’s of the claimed BI member are each considered a wire member in the manner that the sidewalls are slender and elongated elements.
However, Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
the BI member comprises a wire member wound in a spiral configuration
However, Ahimou teaches a system/method for monitoring the efficacy of a sterilization process:
the BI member comprises a wire member wound in a spiral configuration
(paragraph 63+226; the test portion 44d of stem 45 has a spiral shaped cavity 48d in between spiral shaped elongated threads, therein considered wire members as they are elongate and slender, which provides a unique and difficult challenge for a sterilization process; fig 5ab)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Ahimou’s teachings of spiraling cavities between spiraling wire members forming a unique challenge for a sterilization process to the wire members of the modified invention of Talonn in view of Admati, Lombardia, and Corrigan, such that the sidewalls of Lombardia’s BI member are angled relative to its base to form spiraling sidewalls which are disposed with likewise spiraling ridges to form spiral shaped cavities on the radial outer surface of the sidewalls of the BI member so as to resemble the spiral shaped cavity 48d of Ahimou, in order to advantageously arrive at an invention with a sterilization efficacy test element which is uniquely challenging to fully sterilize, see paragraph 52+56+226 of Ahimou, therein improving an operator’s confidence in a sterilization process when a difficult-to-sterilize BI member is confirmed to be fully sterilized.
Regarding Claim 12,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan 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 method of claim 11, wherein disposing the annular portion of the BI member around at least a portion of the tip comprises wrapping a wire around the tip
Examiner notes in light of the modification of Talonn in view of Admati, Lombardia, and Corrigan made above, the BI member of Lombardia resembles the shape of Corrigan’s cover 120, its base 122, and its sidewalls 130, such that the claimed BI member has a base and extending sidewalls, and the extending sidewall’s of the claimed BI member are each considered a wire member in the manner that the sidewalls are slender and elongated elements.
However, Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
Disposing the BI member comprises a wire member wound in a spiral configuration
However, Ahimou teaches a system/method for monitoring the efficacy of a sterilization process:
the BI member comprises a wire member wound in a spiral configuration
(paragraph 63+226; the test portion 44d of stem 45 has a spiral shaped cavity 48d in between spiral shaped elongated threads, therein considered wire members as they are elongate and slender, which provides a unique and difficult challenge for a sterilization process; fig 5ab)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Ahimou’s teachings of spiraling cavities between spiraling wire members forming a unique challenge for a sterilization process to the wire members of the modified invention of Talonn in view of Admati, Lombardia, and Corrigan, such that the sidewalls of Lombardia’s BI member are angled relative to its base to form spiraling sidewalls which are disposed with likewise spiraling ridges to form spiral shaped cavities on the radial outer surface of the sidewalls of the BI member so as to resemble the spiral shaped cavity 48d of Ahimou, in order to advantageously arrive at an invention with a sterilization efficacy test element which is uniquely challenging to fully sterilize, see paragraph 52+56+226 of Ahimou, therein improving an operator’s confidence in a sterilization process when a difficult-to-sterilize BI member is confirmed to be fully sterilized.
Claim(s) 8-10, 15-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over of Talonn in view of Admati, Lombardia, and Corrigan as applied to claims above, and further in view of US 20170211035 A1, henceforth written as Yirava.
Regarding Claim 8,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan 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 syringe sterilization verification assembly of claim 1, wherein the BI member comprises filter paper carrying [sterilization indicators]
Examiner notes that in light of the modification of Talonn in view of Admati, Lombardia, and Corrigan made above, the claimed BI member is made of a carrier made of paper, see paragraph 52+60-66 of Lombardia, and carries chemical indicators of sterilization, see paragraph 55+60 of Lombardia.
However, Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
wherein the BI member comprises filter paper carrying bacteria spores.
However, Yirava teaches a biological indicator for use in sterilization
wherein the BI member comprises filter paper carrying bacteria spores.
(paragraph 3+30-32+36+39-43+48-49; carrier 190 "may comprise filter paper" carrying test organisms like "spores of Geobacillus stearothermophilus, [and] Bacillus atrophaeus,"; fig 8)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to include Yirava’s teachings of providing filter paper with bacteria spores in the BI member of the modified invention in order to advantageously arrive at a diagnostic invention which can detect the presence of certain bacterium after sterilization, see paragraph 3+30-32+36+39-43+48-49 of Yirava.
Regarding claim 9, the modified invention of Talonn in view of Admati, Lombardia, Corrigan, and Yirava teaches:
The syringe sterilization verification assembly of claim 8, wherein the bacteria spores are generally uniformly dispersed across the entire surface of the BI member.
Yirava: (paragraph 49, describes the process for inoculating carrier 190 with test organisms)
Regarding Claim 10, the modified invention of Talonn in view of Admati, Lombardia, Corrigan, and Yirava teaches:
The syringe sterilization verification assembly of claim 8, wherein the bacteria spores comprise Bacillus atrophaeus (BA) bacterial spores and/or Geobacillus stearothermophilus (OST) bacterial spores.
Yirava: (paragraph 3+30-32+36+39-43+48-49; carrier 190 "may comprise filter paper" carrying test organisms like "spores of Geobacillus stearothermophilus, [and] Bacillus atrophaeus,"; fig 8)
Regarding Claim 15,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
disassembling the tip cap assembly and the syringe to access the BI member prior to testing the BI member for sterilization
However, Yirava teaches a biological indicator for use in sterilization
disassembling the tip cap assembly and the syringe to access the BI member prior to testing the BI member for sterilization
(paragraph 38+40+44+49+59; SCBI 100, and its carrier 190 with exposed test organisms are separated from sterilized articles and incubated after being exposed to growth media 140 contained in cap 110; fig 9)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to include the sterilization verification process step of incubating a BI member that was exposed to growth media taught by Yirava to the sterilization process disclosed by the modified invention, by exchanging Talonn’s tip cap assembly with Yirava’s cap 110 containing growth media 140 after sterilization to expose Yirava’s test organisms within the BI member of Lombardia to growth media, therein disassembling the claimed syringe and claimed tip cap assembly, in order to incubate the sterilized test organisms and determine the effectiveness of the steam sterilization process, see paragraph 2+38+40 of Yirava.
Regarding Claim 16,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
wherein testing the BI member for sterilization comprises exposing the BI member to media to check for bacterial growth.
However, Yirava teaches a biological indicator for use in sterilization
wherein testing the BI member for sterilization comprises exposing the BI member to media to check for bacterial growth.
(paragraph 36+38+40+44+49+59; SCBI 100, and its carrier 190 with exposed test organisms, such as bacterial spores, are separated from sterilized articles and incubated after being exposed to growth media 140 contained in cap 110; fig 9)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to include the sterilization verification process step of incubating a BI member that was exposed to growth media taught by Yirava to the sterilization process disclosed by the modified invention, by exchanging Talonn’s tip cap assembly with Yirava’s cap 110 containing growth media 140 after sterilization to expose Yirava’s test organisms within the BI member of Lombardia to growth media, therein disassembling the claimed syringe and claimed tip cap assembly, in order to incubate the sterilized test organisms and determine the effectiveness of the steam sterilization process, see paragraph 2+38+40 of Yirava.
Regarding Claim 19,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
aseptically disassembling the tip cap assembly and the syringe.
However, Yirava teaches a biological indicator for use in sterilization
further comprising aseptically disassembling the tip cap assembly and the syringe.
(paragraph 38+40+44+49+59; SCBI 100, and its carrier 190 with exposed test organisms are separated from sterilized articles and incubated after being exposed to growth media 140 contained in cap 110; fig 9)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to include the sterilization verification process step of incubating a BI member that was exposed to growth media taught by Yirava to the sterilization process disclosed by the modified invention, by exchanging Talonn’s tip cap assembly with Yirava’s cap 110 containing growth media 140 after sterilization to expose Yirava’s test organisms within the BI member of Lombardia to growth media, therein aseptically disassembling the claimed syringe and claimed tip cap assembly, in order to incubate the sterilized test organisms and determine the effectiveness of the steam sterilization process, see paragraph 2+38+40 of Yirava.
Regarding Claim 20,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
wherein testing the syringe and tip cap assembly for sterilization comprises exposing the syringe and tip cap assembly to media to check for bacterial growth.
However, Yirava teaches a biological indicator for use in sterilization
wherein testing the syringe and tip cap assembly for sterilization comprises exposing the syringe and tip cap assembly to media to check for bacterial growth.
(paragraph 36+38+40+44+49+59; SCBI 100, and its carrier 190 with exposed test organisms, such as bacterial spores, are incubated after being exposed to growth media 140 contained in cap 110; fig 9)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to include the sterilization verification process step of incubating a BI member that was exposed to growth media taught by Yirava to the sterilization process disclosed by the modified invention, to expose Yirava’s test organisms within the BI member of Lombardia to Yirava’s growth media 140 and consequently incubate the modified invention in order to incubate the sterilized test organisms and determine the effectiveness of the steam sterilization process, see paragraph 2+38+40 of Yirava.
Claim(s) 18 are rejected under 35 U.S.C. 103 as being unpatentable over of Talonn in view of Admati, Lombardia, and Corrigan as applied to claims above, and further in view of US 20180100131 A1, henceforth written as Brutinel.
Regarding Claim 18,
The modified invention of Talonn in view of Admati, Lombardia, and Corrigan discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Talonn in view of Admati, Lombardia, and Corrigan is silent regarding:
wherein inoculating the interface between the insert and the tip comprises penetrating through the insert with a needle and dispensing an inoculation medium between the insert and the tip.
However, Brutinel teaches a method of using a culturing device
wherein inoculating the interface -- comprises penetrating [the device] with a needle and dispensing an inoculation medium --.
(paragraph 132-136; culture device 100 using an inoculating needle (not enumerated/illustrated) to contact a growth compartment 30 with a sample material, is further incubated, and consequently inspected for the presence/absence of certain microogranisms; fig 1)
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 Brutinel’s method of contacting a sterilization indicator with an inoculating needle to the modified invention, such that Brutinel’s inoculating needle contacts the BI member of Lombardia with Brutinel’s sample material and proceeding to incubate and inspect the BI member to verify any contamination, in order to advantageously arrive at an invention which is exposed to certain biological media with technologically advanced means of a needle in order to inspect the process for contamination with certain microorganisms and improve confidence in the sterilization process in eliminating these microorganisms.
Conclusion
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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