Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 9 is objected to because of the following informalities: typographical error.
Claim 9 recites “an air cavity formed by between…” The examiner recommends amending the claim to recite “an air cavity formed between…” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-15 are 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.
Claim 1 recites the limitation " the inner sidewall of a barrel of a syringe" on line 9. There is insufficient antecedent basis for this limitation in the claim.
Claims 8 and 9 recite a distal and proximal “portion” on lines 1-2 and 5-6. There is insufficient antecedent basis for this limitation in the claim. Additionally, claim 8 recites “greater than 0° and less than about 30°” rendering the claim indefinite. From 0° to 30° is one set range and “about” 30° is another separate range. The examiner recommends the amending the claim to clearly indicate the angle range. Appropriate action is required.
The term “substantially” in claim 10 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate action is required.
Claim 14 recites the limitation " the second apex angle" on line 8. There is insufficient antecedent basis for this limitation in the claim.
All remaining claims are rejected by virtue of dependency from the rejected independent claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 and 16-18 of the instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 18-19 of U.S. Patent No.11969582.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 and 16-18 under examination are anticipated, respectively, by claims 1-14 and 18-19 of the reference patent. Every limitation in the application under examination claims is recited in the conflicting reference patent claims, and the differences between the claims are highlighted below by bolding all limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Instant Application
18/646969
Reference Patent
US11969582B2
Claim 1
A method for increasing a seal between a cylindrical sidewall of a plunger and an inner sidewall of a syringe, the method comprising:
pressurizing a fluid within an interior volume of the syringe to an operating pressure,
deforming a cover of the plunger under operating pressure such that an angle between a proximal surface of a second conical cap of the cover and a distal surface of a first conical cap of a support ring is smaller than when the fluid is not under operating pressure; and
deflecting at least one annular rib on a cylindrical sidewall of the cover in a radially outward direction against the inner sidewall of a barrel of the syringe when the angle is smaller.
Claim 1
A method for increasing a seal between a cylindrical sidewall of a plunger and an inner sidewall of a barrel of a syringe, the method comprising
pressurizing a fluid within an interior volume of the syringe to an operating pressure
deforming the cover such that the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is smaller under operating pressure than when the fluid is not under operating pressure; and
deflecting the at least one annular rib in a radially outward direction against the inner sidewall of the barrel of the syringe when the angle is smaller.
Claim 2
The method of claim 1, wherein the seal between the at least one annular rib and the inner sidewall of the syringe is greater when the at least one annular rib is radially outwardly deflected.
Claim 2
The method of claim 1, wherein the seal between the at least one annular rib and the inner sidewall of the barrel is greater when the at least one annular rib is radially outwardly deflected.
Claim 3
The method of claim 1, wherein the at least one annular rib comprises a first annular rib and a second annular rib on the cylindrical sidewall of the plunger.
Claim 3
The method of claim 1, wherein the at least one annular rib comprises a first annular rib and a second annular rib on the cylindrical sidewall of the plunger.
Claim 4
The method of claim 1, wherein the plunger further comprises a third conical cap disposed over a distal surface of the cover.
Claim 4
The method of claim 1, wherein the plunger further comprises a third conical cap disposed over a distal surface of the cover.
Claim 5
The method of claim 1, wherein the cover further comprises an inner flange to engage an annular groove on the support ring between a shoulder and the first conical cap.
Claim 5
The method of claim 1, wherein the cover further comprises an inner flange to engage an annular groove on the support ring between a shoulder and the first conical cap.
Claim 6
The method of claim 1, wherein the at least one annular rib comprises a first annular rib and a second annular rib on the cylindrical sidewall, and
wherein deflecting the at least one annular rib in a radially outward direction comprises deflecting the first annular rib and the second annular rib in a radially outward direction against the inner sidewall of the syringe when the angle is smaller.
Claim 6
The method of claim 1, wherein the at least one annular rib comprises a first annular rib and a second annular rib on the cylindrical sidewall, and
wherein deflecting the at least one annular rib in a radially outward direction comprises deflecting the first annular rib and the second annular rib in a radially outward direction against the inner sidewall of the barrel when the angle is smaller.
Claim 7
The method of claim 1, wherein pressurizing the fluid within the interior volume of the syringe comprises moving the plunger in a distal direction within the barrel of the syringe.
Claim 7
The method of claim 1, wherein pressurizing the fluid within the interior volume of the syringe comprises moving the plunger in a distal direction within the barrel of the syringe.
Claim 8
The method of claim 1, wherein the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap when the fluid is not under operating pressure is greater than 0° and less than about 30°, and
wherein deforming the cover under operating pressure comprises deforming the cover such that the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is less than angle between the distal portion of the first conical cap and the proximal portion of the second conical cap when the fluid is not under operating pressure.
Claim 8
The method of claim 1, wherein the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is in a range of greater than 0° and less than about 30° when the fluid is not under operating pressure, and
wherein deforming the cover comprises deforming the cover when the fluid is under operating pressure such that the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is less than the range of the angle when the fluid is not
under operating pressure.
Claim 9
The method of claim 1, wherein a predetermined compliance volume of an air cavity formed by between the distal portion of the first conical cap and the proximal portion of the second conical cap when the fluid is not under operating pressure is in a range between 0.1 mL and 10 mL, and
wherein deforming the cover under operating pressure comprises deforming the cover such that a volume of the air cavity is less than the predetermined compliance volume.
Claim 1
an air cavity defined between the first conical cap and the second conical cap… wherein a distal portion of the first conical cap forms an angle with a proximal portion of the second conical cap;
Claim 9
The method of claim 1, wherein the predetermined compliance volume of the air cavity is in a range between 0.1 mL and 10 mL when the fluid is not under operating pressure, and
wherein deforming the cover comprises deforming the cover such that a volume of the air cavity under operating pressure is less than the predetermined compliance volume.
Claim 10
The method of claim 9, wherein the volume of the air cavity under operating pressure is substantially zero.
Claim 10
The method of claim 9, wherein the volume of the air cavity under operating pressure is substantially zero.
Claim 11
The method of claim 9, wherein deforming the cover such that the volume of the air cavity under operating pressure is less than the predetermined compliance volume further comprises:
venting air in the predetermined compliance volume through at least one aperture defined by the support ring into the barrel of the syringe proximal to the plunger.
Claim 11
The method of claim 9, wherein deforming the cover such that the volume of the air cavity under operating pressure is less than the predetermined compliance volume further comprises:
venting air in the predetermined compliance volume through at least one aperture [[is]] defined by the support ring into the barrel of the syringe proximal to the plunger.
Claim 12
The method of claim 1, further comprising moving the plunger in a distal direction within the barrel of the syringe.
Claim 12
The method of claim 1, further comprising moving the plunger in a distal direction within the barrel of the syringe.
Claim 13
The method of claim 12, further comprising delivering the fluid through an outlet port at a distal end of the syringe.
Claim 13
The method of claim 12, further comprising delivering the fluid through an outlet port at a distal end of the syringe.
Claim 16
A plunger, comprising:
a support ring comprising a first conical cap;
a cover disposed over and coupled to the support ring, wherein the cover comprises a second conical cap and a cylindrical side wall, wherein the cylindrical sidewall comprises at least one annular rib; and
an air cavity defined between the first conical cap and the second conical cap, the air cavity defining a predetermined compliance volume such that the cover deforms and flexes into the compliance volume under injection pressure,
wherein a distal portion of the first conical cap forms an angle with a proximal portion of the second conical cap, and
wherein the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is smaller when the plunger is under operating pressure from an injection than when the plunger is not under pressure from the injection, and wherein the at least one annular rib is radially outwardly deflected against an inner wall of a syringe barrel when the angle is smaller.
Claim 14
a plunger located within the inner wall of the barrel, the plunger comprising:
a support ring comprising a first conical cap;
a cover disposed over and coupled to the support ring, wherein the cover comprises a second conical cap and a cylindrical sidewall, wherein the cylindrical sidewall comprises at least one annular rib; and
an air cavity defined between the first conical cap and the second conical cap, the air cavity defining a predetermined compliance volume such that when the plunger undergoes injection pressurization, the cover deforms and flexes into the compliance volume,
wherein a distal portion of the first conical cap forms an angle with a proximal portion of the second conical cap, and
wherein, due to the deforming and flexing of the cover, the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is smaller when the plunger is under operating pressure than when the plunger is not under pressure, and wherein the at least one annular rib is radially outwardly deflected against the inner wall of the barrel when the angle is smaller.
Claim 17
The plunger of claim 16, wherein a predetermined volume of the air cavity is selected in a range between 0.1 mL and 10 mL.
Claim 19
The system of claim 14, wherein a predetermined volume of the air cavity is selected in a range between 0.1 mL and 10 mL.
Claim 18
The plunger of claim 16, wherein the between the distal portion of the first conical cap and the proximal portion of the second conical cap is greater than 0° and less than about 30° when the plunger is not under pressure from the injection.
Claim 18
The system of claim 14, wherein the angle defined between the first conical cap of the support ring and the second conical cap of the cover is in a range of greater than 0° and less than about 30° when the fluid is not under operating pressure.
As shown in the mapping above, claims 1-14 and 18-19 of the reference patent include all the limitations of claims 1-13 and 16-18 of the instant application, while also reciting further limitations.
For example, claim 1 of the instant application differs from the reference patent in that it recites distal and proximal “surface” rather than “portion”. However, within the broadest reasonable interpretation, a portion may be a specified, measured or a bounded part of a larger/whole structure. Thus, the “portion” of the reference patent claim 1 anticipates the “surface” of claim 1 of the instant application.
For example, claim 9 recites that an air cavity is “formed by between the distal portion of the first conical cap and the proximal portion of the second conical cap” and the reference patent does not appear to expressly recite the formation of the air cavity in its claim 9. However, by virtue of dependency from claim 1, the reference patent incorporates “an air cavity defined between the first conical cap and the second conical cap… wherein a distal portion of the first conical cap forms an angle with a proximal portion of the second conical cap” and thus anticipates all the limitation of claim 9 of the instant application.
Another example, claims 2 and 6 the instant applicate differ from the reference patent by reciting “inner sidewall of the syringe” rather than “inner sidewall of the barrel”. However, claim 1 of the reference patent recites “inner sidewall of a barrel of a syringe” and by virtue of dependency and within broadest reasonable interpretation, the “barrel” of claims 2 and 6 of the reference patent anticipate the “inner sidewall of the syringe” of the instant application. Likewise, in claim 16, the “barrel” of the reference patent anticipates the “syringe barrel” of the instant application.
Claims 14-15 of the instant application are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23 and 25 of U.S. Patent No.11351306.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 14-15 under examination are anticipated, respectively, by claims 23 and 25 of the reference patent. Every limitation in the application under examination claims is recited in the conflicting reference patent claims, and the differences between the claims are highlighted below by bolding all limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Instant Application
18/646969
Reference Patent
US11351306B2
Claim 14
A method of making a syringe, comprising:
providing a syringe barrel;
making a plunger in accordance with a method, the method comprising:
providing a support ring, the support ring comprising a first conical cap having a first apex angle, a shoulder, and an annular groove between the shoulder and the first conical cap;
defining an air cavity between the first conical cap and the second conical cap based on a difference between the first apex angle and the second apex angle, the air cavity defining a predetermined compliance volume such that when the plunger undergoes injection pressurization, the cover deforms and flexes into the compliance volume,
wherein a distal portion of the first conical cap forms an angle with a proximal portion of the second conical cap, and
wherein, due to the deforming and flexing of the cover, the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is smaller when the plunger is under operating pressure than when the plunger is not under pressure, and wherein the at least one annular rib is radially outwardly deflected against an inner wall of a syringe barrel when the angle is smaller.
Claim 23
A method of making a plunger, the method comprising:
providing a support ring, the support ring comprising a first conical cap having a first apex angle, a shoulder, and an annular groove between the shoulder and the first conical cap;
defining an air cavity between the first conical cap and the second conical cap based on a difference between the first apex angle and the second apex angle, the air cavity defining a predetermined compliance volume such that when the plunger undergoes injection pressurization, the cover deforms and flexes into the compliance volume,
wherein a distal portion of the first conical cap forms an angle with a proximal portion of the second conical cap, and
wherein, due to the deforming and flexing of the cover, the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is smaller when the plunger is under pressure from an injection than when the plunger is not under pressure from the injection, and wherein the at least one annular rib is radially outwardly deflected against an inner wall of a syringe barrel when the angle is smaller.
Claim 15
The method of claim 14, further comprising attaching a third conical cap to a distal portion of the second conical cap of the cover, wherein the third conical cap comprises am overmolded element.
Claim 25
The method of claim 23, further comprising attaching a third conical cap to a distal portion of the second conical cap of the cover, wherein the third conical cap comprises an overmolded element.
As shown in the mapping above, claims 23 and 25 of the reference patent includes all the limitations of claims 14-15 of the instant application.
For example, claim 14 of the instant application differs from the reference patent in that it recites “a method of making a syringe, comprising: providing a syringe barrel” in addition to “making a plunger in accordance with a method, the method comprising” which is aligns with the reference patent. However, within the broadest reasonable interpretation, it can be understood that a plunger with all the same limitations and structural components is a part of a larger syringe structure. Thus, the “the method of making a plunger” of the reference patent claim 23 anticipates the method of claim 14 of the instant application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hitchins (EP 1166807 A1, herein, Hitchins).
Regarding claim 1, Hitchins discloses a method for increasing a seal between a cylindrical sidewall (truncated cone 82 – Fig.1) of a plunger (plunger body 5 – Fig.1) and an inner sidewall (inner most side of the syringe walls, see annotated Fig.2) of a syringe (syringe body 3 – Fig.2) (“the plunger body 5 and the inner surface of the syringe body 3 and thereby compressed to a higher degree to produce an enhanced sealing effect”, see para [0034]), the method comprising:
pressurizing a fluid within an interior volume of the syringe (syringe body 3 – Fig.2) to an operating pressure (under broadest reasonable interpretation, the examiner interprets the advancement of the plunger as pressurizing the liquid to be injected (“when the piston 13 is further projected, the plunger 4 advances, whereby the liquid agent filled in the syringe body 3 can be injected”, see para [0086])),
deforming a cover (cover 9) of the plunger (plunger body 5 – Fig.1) under operating pressure such that an angle (see annotated Fig.2) between a proximal surface (see annotated Fig.2) of a second conical cap (conical portion 91 – Fig.2) of the cover (cover 9) and a distal surface (see annotated Fig.2) of a first conical cap (conical portion 81 – Fig.2) of a support ring (third component 8 – Fig.2) is smaller than when the fluid is not under operating pressure (under broadest reasonable interpretation, the examiner interprets the angle in a non-operative state as the gap between the two surfaces (“the hollow conical portion 91 of the elastic cover 9 covers the conical portion 81 of the plunger body 5 with a small space 90 left therebetween”, see para [0015])); and
deflecting at least one annular rib (ribs 93 – Fig.2) on a cylindrical sidewall of the cover (cover 9 – Fig.2) in a radially outward direction against the inner sidewall of a barrel (under broadest reasonable interpretation, the examiner interprets a barrel to be a hollow tube capable of holding fluid, hence, the syringe body 3, see annotated Fig.2) of the syringe (syringe body 3 – Fig.2) when the angle is smaller (“a plurality of ribs 93, 93 are formed on the outer peripheral surface of the cylindrical portion 92 over the entire circumference thereof”, see para [0013]).
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Regarding claim 2, Hitchins discloses the method of claim 1, wherein the seal between the at least one annular rib (ribs 93 – Fig.2) and the inner sidewall (see annotated Fig.2) of the syringe (syringe body 3 – Fig.2) is greater when the at least one annular rib is radially outwardly deflected (“the cylindrical portion 92 is provided on its outer periphery with a plurality of, preferably at least three, ribs 93 for affording an effective liquid-tight seal to hold a liquid agent filled in the syringe body 4”, see para [0076], Fig.2).
Regarding claim 3, Hitchins discloses the method of claim 1, wherein the at least one annular rib (ribs 93 – Fig.2) comprises a first annular rib and a second annular rib on the cylindrical sidewall (truncated cone 82 – Fig.2) of the plunger (plunger 4 – Fig.2) (“the cylindrical portion 92 is provided on its outer periphery with a plurality of, preferably at least three, ribs 93”, see para [0076], Fig.2).
Regarding claim 4, Hitchins discloses the method of claim 1, wherein the plunger (plunger 4 – Fig.2) further comprises a third conical cap (elastic cover 9) disposed over a distal surface of the cover (“the hollow conical portion 91 of the elastic cover 9 covers the conical portion 81 of the plunger body 5”, see para [0015], Fig. 1).
Regarding claim 5, Hitchins discloses the method of claim 1, wherein the cover (cover 9 – Fig.2) further comprises an inner flange (inward flange 94 – Fig.2) to engage an annular groove (recessed portion 52 – Fig.2) on the support ring (third component 8) between a shoulder (backplate 62 – Fig.2) and the first conical cap (conical portion 81 – Fig.2) (“the inward flange 94 formed along the opening edge of the elastic cover 9 is fitted in the recessed portion 52”, see para [0093], Fig.2).
Regarding claim 6, Hitchins discloses the method of claim 1, wherein the at least one annular rib (ribs 93 – Fig.2) comprises a first annular rib and a second annular rib on the cylindrical sidewall (“the cylindrical portion 92 is provided on its outer periphery with a plurality of, preferably at least three, ribs 93”, see para [0076], Fig.2), and
wherein deflecting the at least one annular rib (ribs 93 – Fig.2 ) in a radially outward direction comprises deflecting the first annular rib and the second annular rib in a radially outward direction against the inner sidewall of the syringe (see inner sidewall of syringe body 3 in annotated Fig.2) when the angle is smaller (under broadest reasonable interpretation, examiner interprets any means or force causing the annular ribs to apply weight on the inner sidewall of the syringe as deflecting the annular ribs radially outward (“pressing the inner surface of the syringe body 3 to achieve a further improved sealing effect”, see para [0037], Fig.2)).
Regarding claim 7, Hitchins discloses the method of claim 1, wherein pressurizing the fluid within the interior volume of the syringe comprises moving the plunger (plunger 4 – Fig.2) in a distal direction within the barrel of the syringe (under broadest reasonable interpretation, the examiner interprets a barrel to be a hollow tube capable of holding fluid, hence, the syringe body 3, see annotated Fig.2) (“the internal pressure of the syringe 2 is increased by the advance of the plunger 4”, see para [0030]).
Regarding claim 12, Hitchins discloses the method of claim 1, further comprising moving the plunger (plunger body 4 – Fig.2) in a distal direction within the barrel of the syringe (under broadest reasonable interpretation, the examiner interprets a barrel to be a hollow tube capable of holding fluid, hence, the syringe body 3, see annotated Fig.2).
Regarding claim 13, Hitchins discloses the method of claim 12, further comprising delivering the fluid through an outlet port (nozzle 30 – Fig.10) at a distal end of the syringe (“inject a liquid agent filled in the syringe body 3 into the vascular system of the human body or an animal through a tube (not shown) from a nozzle 30 at the front end of the syringe body 3”, see para [0005]).
Regarding claim 14, Hitchins discloses a method of making a syringe (syringe body 3 – Fig.2), comprising:
providing a syringe barrel (under broadest reasonable interpretation, the examiner interprets a barrel to be a hollow tube capable of holding fluid, hence, the syringe body 3, see annotated Fig.2);
making a plunger (plunger body 4 – Fig.2) in accordance with a method, the method comprising:
providing a support ring (third component 8 – Fig.2), the support ring comprising a first conical cap (conical portion 81 – Fig.2) having a first apex angle (under broadest reasonable interpretation, the examiner interprets the apex angle as the internal angle formed at the apex or highest pointed tip of the conical portion 81 – Fig.2), a shoulder (backplate 61 – Fig.2), and an annular groove (groove 68 – Fig.2) between the shoulder and the first conical cap;
defining an air cavity (small clearance 90 – Fig.2) between the first conical cap (conical portion 81 – Fig.2) and the second conical cap (conical portion 91 – Fig.2) based on a difference between the first apex angle and the second apex angle (“the hollow conical portion 91 of the elastic cover 9 covers the conical portion 81 of the plunger body 5 with a small space 90 left therebetween”, see para [0015]), the air cavity defining a predetermined compliance volume such that when the plunger undergoes injection pressurization, the cover deforms and flexes into the compliance volume,
wherein a distal portion of the first conical cap (conical portion 81 – Fig.2) forms an angle (see annotated Fig.2) with a proximal portion of the second conical cap (conical portion 91 – Fig.2) (“the hollow conical portion 91 of the elastic cover 9 covers the conical portion 81 of the plunger body 5 with a small space 90 left therebetween”, see para [0015]), and
wherein, due to the deforming and flexing of the cover, the angle between the distal portion of the first conical cap and the proximal portion of the second conical cap is smaller when the plunger is under operating pressure than when the plunger is not under pressure (under broadest reasonable interpretation, the examiner interprets pushing the plunger as operating pressure and evidently when the pressure is released the angle becomes bigger and returns to its resting position (“when the plunger 4 is pushed forward under an extremely high pressure, the elastic cover 9 stretches rearward while sliding over… and compressed to a higher degree to produce an enhanced sealing effect”, see para [0034])), and wherein the at least one annular rib is radially outwardly deflected against an inner wall (“a plurality of, preferably at least three, ribs 93 for affording an effective liquid-tight seal to hold a liquid agent filled in the syringe body 4”, see para [0076], Fig.2) of a syringe barrel (under broadest reasonable interpretation, the examiner interprets a barrel to be a hollow tube capable of holding fluid, hence, the syringe body 3, see annotated Fig.2) when the angle is smaller.
Regarding claim 15, Hitchins discloses the method of claim 14, further comprising attaching a third conical cap (elastic cover 9 – Fig.2) to a distal portion (see annotated Fig.2) of the second conical cap (conical portion 91 – Fig.2) of the cover (cover 9), wherein the third conical cap comprises an overmolded element (under broadest reasonable interpretation, the examiner interprets the outer most layer or cap as an overmolded element (elastic cover 9 – Fig.2)).
Regarding claim 16, Hitchins discloses a plunger (plunger body 5 – Fig.1), comprising:
a support ring (third component 8 – Fig.9) comprising a first conical cap (conical portion 81 – Fig.9);
a cover (cover 9 – Fig.2) disposed over and coupled to the support ring (third component 8 – Fig.2), wherein the cover comprises a second conical cap (conical portion 91 – Fig.2) and a cylindrical side wall (cylindrical portion 92 – Fig.2), wherein the cylindrical sidewall comprises at least one annular rib (ribs 93 – Fig.2); and
an air cavity (small clearance 90 – Fig.2) defined between the first conical cap (conical portion 81 – Fig.2) and the second conical cap (conical portion 91 – Fig.2), the air cavity defining a predetermined compliance volume such that the cover (cover 9 – Fig.2) deforms and flexes into the compliance volume under injection pressure (“when the plunger 4 is pushed forward under an extremely high pressure, the elastic cover 9 stretches rearward while sliding over… and compressed to a higher degree to produce an enhanced sealing effect”, see para [0034]),
wherein a distal portion (see annotated Fig.2) of the first conical cap (conical portion 81 – Fig.2) forms an angle (see annotated Fig.2) with a proximal portion (conical portion 91 – Fig.2) of the second conical cap (see annotated Fig.2), and
wherein the angle between the distal portion (see annotated Fig.2) of the first conical cap (conical portion 81 – Fig.2) and the proximal portion (see annotated Fig.2) of the second conical cap (conical portion 91 – Fig.2) is smaller when the plunger (plunger body 4 – Fig.2) is under operating pressure from an injection than when the plunger is not under pressure from the injection (under broadest reasonable interpretation, the examiner interprets pushing the plunger as operating pressure from an injection and evidently when the pressure is released the angle becomes bigger and returns to its resting position (“when the plunger 4 is pushed forward under an extremely high pressure, the elastic cover 9 stretches rearward while sliding over… and compressed to a higher degree to produce an enhanced sealing effect”, see para [0034])), and wherein the at least one annular rib is radially outwardly deflected against an inner wall (“a plurality of, preferably at least three, ribs 93 for affording an effective liquid-tight seal to hold a liquid agent filled in the syringe body 4”, see para [0076], Fig.2) of a syringe barrel (under broadest reasonable interpretation, the examiner interprets a barrel to be a hollow tube capable of holding fluid, hence, the syringe body 3, see annotated Fig.2) when the angle is smaller.
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.
Claims 8-11 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hitchins.
Regarding claim 8, Hitchins discloses the method of claim 1, as recited above, wherein the angle (see annotated Fig.2) between the distal portion (see annotated Fig.2) of the first conical cap (conical portion 81 – Fig.2) and the proximal portion (see annotated Fig.2) of the second conical cap (conical portion 91 – Fig.2) when the fluid is not under operating pressure is greater than 0° and less than about 30°, and
wherein deforming the cover (cover 9 – Fig.2) under operating pressure comprises deforming the cover such that the angle (see annotated Fig.2) between the distal portion (see annotated Fig.2) of the first conical cap (conical portion 81 – Fig.2) and the proximal portion (see annotated Fig.2) of the second conical cap (conical portion 91 – Fig.2) is less than angle between the distal portion of the first conical cap and the proximal portion of the second conical cap when the fluid is not under operating pressure (under broadest reasonable interpretation, the examiner interprets pushing the plunger as operating pressure and evidently when the pressure is released the angle becomes bigger and returns to its resting position (“when the plunger 4 is pushed forward under an extremely high pressure, the elastic cover 9 stretches rearward while sliding over… and compressed to a higher degree to produce an enhanced sealing effect”, see para [0034])).
Hitchins discloses that the “the conical portion 81 has an angle of about 45 deg with the axis thereof” (see para [0067]). However, Hitchins does not appear to expressly disclose that the angle “is greater than 0° and less than about 30°”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of Hitchins from “about 45” to between 0° and 30° since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0012] indicating the angle “may” be within the claimed range).
Regarding claim 9, Hitchins discloses the method of claim 1, wherein a predetermined compliance volume of an air cavity (small clearance 90 – Fig.2) formed by between the distal portion (see annotated Fig.2) of the first conical cap (conical portion 81 – Fig.2) and the proximal portion (see annotated Fig.2) of the second conical cap (conical portion 91 – Fig.2) when the fluid is not under operating pressure is in a range between 0.1 mL and 10 mL, and
wherein deforming the cover (cover 9 – Fig.2) under operating pressure comprises deforming the cover such that a volume of the air cavity (small clearance 90 – Fig.2) is less than the predetermined compliance volume (under broadest reasonable interpretation, the examiner interprets that the volume of the air cavity will reduce when pressure is applied causing the cover to stretch, hence, resulting in a smaller volume when compressed (“when the plunger 4 is pushed forward under an extremely high pressure, the elastic cover 9 stretches rearward while sliding over… and compressed to a higher degree to produce an enhanced sealing effect”, see para [0034])).
Hitchins discloses a that “a small clearance 90 is formed between the conical portion 81 of the plunger body 5” (see para [0082], Fig.2). However, Hitchins does not appear to expressly disclose that the air cavity “when the fluid is not under operating pressure is in a range between 0.1 mL and 10 mL”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the air cavity of Hitchins to a range between 0.1mL to 10mL since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0012] indicating the angle “may” be within the claimed range).
Regarding claim 10, Hitchins discloses the method of claim 9, wherein the volume of the air cavity (small clearance 90 – Fig.2) under operating pressure is substantially zero (under broadest reasonable interpretation, the examiner interprets that the air cavity compresses and reduces volume as more pressure is applied, hence, under maximum pressure the volume may be reduced to substantially zero strengthening the syringe seal (“under an extremely high pressure, the elastic cover 9 stretches rearward while sliding over… and compressed to a higher degree to produce an enhanced sealing effect”, see para [0034])).
Regarding claim 11, Hitchins discloses the method of claim 9, wherein deforming the cover (cover 9 – Fig.2) such that the volume of the air cavity (small clearance 90 – Fig.2) under operating pressure is less than the predetermined compliance volume further comprises:
venting air (air vents 85 – Fig.2) in the predetermined compliance volume through at least one aperture defined by the support ring (“third component 8 has air vents 85 extending through the conical portion 81”, see para [0070]) into the barrel of the syringe (see annotated Fig.2) proximal to the plunger (plunger body 4 – Fig.2).
Regarding claim 17, Hitchins discloses the plunger (plunger body 4 – Fig.2) of claim 16, wherein a predetermined volume of the air cavity (small clearance 90 – Fig.2) is selected in a range between 0.1 mL and 10 mL.
Hitchins discloses a that “a small clearance 90 is formed between the conical portion 81 of the plunger body 5” (see para [0082], Fig.2). However, Hitchins does not appear to expressly disclose that the air cavity “when the fluid is not under operating pressure is in a range between 0.1 mL and 10 mL”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the air cavity of Hitchins to a range between 0.1mL to 10mL since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0012] indicating the angle “may” be within the claimed range).
Regarding claim 18, Hitchins discloses the plunger (plunger body 4 – Fig.2) of claim 16, wherein the between the distal portion (see annotated Fig.2) of the first conical cap (conical portion 81 – Fig.2) and the proximal portion (see annotated Fig.2) of the second conical cap (conical portion 91 – Fig.2) is greater than 0° and less than about 30° when the plunger is not under pressure from the injection.
Hitchins discloses that the “the conical portion 81 has an angle of about 45 deg with the axis thereof” (see para [0067]). However, Hitchins does not appear to expressly disclose that the angle “is greater than 0° and less than about 30°”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of Hitchins from “about 45” to between 0° and 30° since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0012] indicating the angle “may” be within the claimed range).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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