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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Sweden on 10/19/21. It is noted, however, that applicant has not filed a certified copy of the SE 2100156-5 application as required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “21” has been used to designate both “a liquid tight thread arrangement” and “a liquid tight friction arrangement” on Page 4, lines 16-17 and in Figures 4a and 4b. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: container wall/barrel wall 18. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: there appears to be typos regarding “glycagon” as opposed to “glucagon” on Page 1 lines 11 and 41, Page 3 line 41, and Page 5 line 7. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because there is a lack of antecedent basis for the following limitations:
“the plunger length” in line 11
“the container length” in line 11
“the container wall” in line 15
“the inner wall of the container” in line 19
“the peripheral surface of the piston portion” in lines 19-20
Appropriate correction is required.
Claim 1 is further objected to because there appears to be a typo regarding “when the syringe is arranged in a delivery state with the piston portion drawn backwards, a certain portion of the plunger extending beyond the container rear end portion;” in lines 12-14 as opposed to “when the syringe is arranged in a delivery state with the piston portion drawn backwards, a certain portion of the plunger extends beyond the container rear end portion;” for example. Appropriate correction is required.
Claim 16 is objected to because there is a lack of antecedent basis for “the piston” in line 3. Appropriate correction is required.
Claim 17 is objected to because there is a lack of antecedent basis for “the size of the syringe” in line 1 and “the kind of liquid to be injected” in line 2. Appropriate correction is required.
Claim 20 is objected to because there is a lack of antecedent basis for “the rear end of the plunger” in line 1. Appropriate correction is required.
Claim 22 is objected to because there is a lack of antecedent basis for “the front position of the plunger” in line 5, “the locking flange arrangement of the piston portion” in line 6, and “the internal stop arrangement of the container” in line 7. Appropriate correction is required.
Claim 22 is further objected to because there appears to be a typo regarding “a container rear end portion” in line 1 as opposed to “the container rear end portion”. Appropriate correction is required.
Claim 23 is objected to because there appears to be a typo regarding “glycagon” in line 2 as opposed to “glucagon”. 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 16, 18, and 21 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.
Regarding claim 16, the preamble of “The syringe according to claim 1” in line 1 renders the claim indefinite. The dependency of claim 16 is unclear because Claim 1 has been canceled. For examination purposes, claim 16 has been interpreted to be dependent upon claim 11.
Further regarding claim 16, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitation “the grip portion preferably being fastened onto the piston by a snap arrangement” has been interpreted as an optional limitation, not positively recited or required by the claim.
Regarding claim 18, the limitation “it is adapted to container a single vaccine dose” in lines 1-2 renders the claim indefinite. It is unclear what structure “it” refers to. For examination purposes, the limitation “it is adapted to container a single vaccine dose” has been interpreted as “the syringe is adapted to container a single vaccine dose”.
Regarding claim 21, the preamble of “The syringe according to claim 10” in line 1 renders the claim indefinite. The dependency of claim 21 is unclear because Claim 1 has been canceled. For examination purposes, claim 21 has been interpreted to be dependent upon claim 20.
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 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Von Pechmann (USPN 3253592).
Regarding claim 11, Von Pechmann discloses a syringe (Figure 2) comprising:
a front portion (collar 19) carrying a hollow, axially extending needle (needle 14);
a container (barrel 11) running from said front portion and forming a container rear end portion (Figure 2, at finger grips 21);
a plunger (plunger 12) extending and being movable axially in the container (“the plunger is moved through the barrel on either the vacuum or pressure stroke.” [Col 1, lines 72 – Col 2, line 2]);
a needle rear end (hub 16) being in fluid connection with the container (Figure 2);
the plunger being arranged to suck liquid through the needle from the container when drawn away from the needle (“the plunger is moved through the barrel on either the vacuum or pressure stroke.” [Col 1, lines 72 – Col 2, line 2], wherein the vacuum stroke would allow the syringe to suck liquid through the needle) and to discharge liquid through the needle when pushed towards the needle (“by applying pressure on the plunger most of the liquid in the barrel will be squeezed out through the passage to the needle 15.” [Col 4, line 74]);
the plunger having a piston portion (sealing tip 13) turned to the needle rear end (Figure 2);
the plunger length in relation to the container length being adapted so that when the syringe is arranged in a delivery state with the piston portion drawn backwards, a certain portion of the plunger extending beyond the container rear end portion (Figure 2 showing a rear portion of the plunger 12 extending beyond the finger grip 21);
wherein the container wall (forming barrel 11) is made of a cylindrically shaped pipe like body of a material (Figures 1-3), having a certain resiliency (“a thin, resilient, transparent plastic barrel 11” [Col 2, lines 38]) and an inner diameter (D1) smaller than the outer diameter (D2) of the piston portion (“The outside diameter of the plunger sealing tip at the peripheral cylindrical surface…should be slightly larger than the maximum internal diameter of the barrel” [Col 1, lines 50-54]);
the container is widened locally by the piston portion (“The barrel 11 actually expands somewhat as the plunger 12 with the sealing tip 13 is forced down through the barrel 11, particularly at the inner end of the barrel 11 which has a slightly smaller diameter than the outer open end.” [Col 3, lines 49-53]); and
a sealing action appears between the inner wall of the container and the peripheral surface of the piston portion due to a pressure exerted by the widened container wall (“The barrel of the plunger should be relatively thin, flexible and resilient, and the plunger sealing tip should have a relatively narrow annular ring contacting the barrel...the annular ring should be integrally formed and resiliently connected to the cylindrical body of the plunger tip to permit a slight compression and expansion within the barrel which also expands to maintain a tight seal as the plunger is moved through the barrel on either the vacuum or pressure stroke” [Col 1, line 63 – Col 2, line 2]).
Regarding claim 12, Von Pechmann discloses the syringe according to claim 11, wherein the container is made of a polymeric material (“a very thin wall, polypropylene barrel” [Col 1, lines 43]) to provide a desired resilience and sealing properties of the container wall (“The barrel of the plunger should be relatively thin, flexible and resilient, and the plunger sealing tip should have a relatively narrow annular ring contacting the barrel. the plunger sealing tip may be integrally formed or snapped onto the tip end of the plunger; but the annular ring should be integrally formed and resiliently connected to the cylindrical body of the plunger tip to permit a slight compression and expansion within the barrel which also expands to maintain a tight seal as the plunger is moved through the barrel on either the vacuum or pressure stroke.” [Col 1, lines 63 – Col 2, line 2]).
Regarding claim 13, Von Pechmann discloses the syringe according to claim 11, wherein the needle is carried by a connection portion (hub 16) arranged to be connected to a container front portion by means of a liquid tight thread arrangement or liquid tight friction arrangement or a fixed needle connection extending from the container (“The conventional hypodermic needle 14 has a cannula 15 secured to a hub 16 which is staked tightly onto the tip 17 on the end of the barrel 11.” [Col 2, lines 41-43]).
Regarding claim 14, Von Pechmann discloses the syringe according to claim 11, wherein the plunger has a front connection portion (tip end 25) arranged to fit into a rear opening (within cylindrical sleeve 31) of the piston portion (“The sealing tip 13 is adapted to snap on over the plunger tip end 25 until the cylindrical portion 27 firmly engages the cylindrical body or sleeve 31.” [Col 2, lines 69-71]).
Regarding claim 15, Von Pechmann discloses the syringe according to claim 11, wherein the plunger (plunger 12) has a cross like cross section (“The body of the plunger 12 is provided with four radial ribs which form a light rigid central body portion 22” [Col 2, line 49-51]; see cross-section in Figure 7, for example).
Regarding claim 16, Von Pechmann discloses the syringe according to claim 1 [claim 11, see rejection under 35 USC 112 above], wherein the syringe comprises a grip portion (finger grip 21) having extensions for holding the syringe during injection by the syringe (“” [Col 2, lines 47-49]), the grip portion preferably being fastened onto the piston by a snap arrangement [See rejection under 35 USC 112 above, this limitation interpreted as optional/not positively recited by the claim].
Regarding claim 17, Von Pechmann discloses the syringe according to claim 11, wherein the size of the syringe is adapted to the kind of liquid to be injected such that if a larger volume of liquid is desired a bigger size of the syringe is necessary for obtaining a desired effect of a certain injection (Figure 1, showing measurement markings on size side of barrel 11).
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.
Claims 18-19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Von Pechmann (USPN 3253592) in view of Palmer (USPN 4820272).
Regarding claims 18-19, Von Pechmann discloses the syringe according to claim 11.
Von Pechmann fails to explicitly discloses wherein it [syringe, see rejection under 35 USC 112 above] is adapted to contain a single vaccine dose, as required by claim 18 and wherein the single vaccine dose is about one milliliter, as required by claim 19.
Palmer discloses a syringe (hypodermic syringe 10) adapted to contain a single vaccine dose of about 1 milliliter (“The lower engagement zone 18 is provided about one third of the height of the cylinder 11 so that the effective volume therebelow for receiving vaccine is at least about one milliliter.” [Col 2, lines 33-36]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the syringe of Von Pechmann to be adapted to contain a single vaccine dose of about 1 milliliter based on the teachings of Palmer to allow for effective vaccination by utilizing a syringe that allows the full volume of vaccine to be delivered without allowing for reuse of the syringe (Palmer [Col 1, lines 51-62]). Additionally, it is noted that the claims as currently recited do not positively recite or claim the single vaccine dose or a specific volume of the syringe itself.
Regarding claim 23, Von Pechmann discloses the syringe according to claim 11.
Von Pechmann fails to explicitly disclose the liquid comprising insulin, glycagon, or a vaccine.
Palmer discloses a syringe (hypodermic syringe 10) comprising a needle (needle 16), a container (cylinder 11), and a plunger (plunger 12) being arranged to suck liquid through the needle from the container when drawn away from the needle and to discharge liquid through the needle when pushed towards the needle; the plunger having a piston portion turned to the needle rear end (see all of [Col 3, lines 10-33]); the liquid comprising insulin, glycagon, or a vaccine (“The lower engagement zone 18 is provided about one third of the height of the cylinder 11 so that the effective volume therebelow for receiving vaccine is at least about one milliliter.” [Col 2, lines 33-36]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the syringe of Von Pechmann such that the liquid comprising insulin, glycagon, or a vaccine based on the teachings of Palmer to allow for effective vaccination by utilizing a syringe that allows the full volume of vaccine to be delivered without allowing for reuse of the syringe (Palmer [Col 1, lines 51-62]). Additionally, it is noted that the claims as currently recited do not positively recite or claim the liquid.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Von Pechmann (USPN 3253592) in view of Dadachanji (US 20210077738).
Regarding claim 20, Von Pechmann discloses the syringe according claim 11, wherein the rear end of the plunger comprises an end plate (thumb rest 23) for moving the plunger in the container (“integrally formed outer disk or thumb rest 23 adapted to be engaged by the thumb in operation of the syringe.” [Col 2, lines 51-53]).
Von Pechmann fails to explicitly disclose the end plate to be concealed in the end of the container during a locked state of the syringe.
Dadachanji discloses a syringe (Figure 4b) comprising a container (syringe barrel 10), a plunger (plunger rod 5) comprising an end plate (circular disc 50) to be concealed in the end of the container during a locked state of the syringe (“As shown in FIG. 5b, finally the disc-shaped proximal end 50 of the plunger rod will have slid beyond the front ends of the bevels 35 of the locking noses 34 to be fully accommodated inside the chamber or receiving volume 37 formed by the circumferential side-wall of the plunger rod locking portion 30. More specifically, the disc-shaped proximal end 50 of the plunger rod will have slid into the interspace formed between the bottom sides 36 of the locking noses 34 (see FIG. 2a) and the annular stop surface 32 at the bottom of the plunger rod locking portion 30, so that the resilient locking noses 34 will flex backward into the communication channel 29 to recapture their home position.” [0094]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the syringe of Von Pechmann to include the end plate is concealed in the end of the container during a locked state of the syringe based on the teachings of Dadachanji to prevent reuse of the syringe after an injection is complete by preventing withdrawal of the plunger (Dadachanji [0096]).
Regarding claim 21, modified Von Pechmann teaches the syringe according claim 10 [claim 20, see rejection under 35 USC 112 above], wherein the end plate (disk 23) is circular (wherein a “disk” is circular, best shown in Figure 1)
Regarding claim 22, Von Pechmann discloses the syringe according to claim 11.
Von Pechmann fails to explicitly discloses a container rear end portion comprises an internal lock arrangement and a plunger portion extending a certain distance beyond the container rear end portion and comprising an outer stop arrangement, so that when the plunger, comprising a connection portion in a discharge state is pushed forward to the front position of the plunger in said container, the locking flange arrangement of the piston portion is pushed forward, passing the internal stop arrangement of the container, thereby locking the plunger in the container in a non re-usable state of the syringe.
Dadachanji discloses a syringe (Figure 4b) comprising a container (syringe barrel 10) and a plunger (plunger rod 5), wherein a container rear end portion (plunger rod locking device 2) comprises an internal lock arrangement (plunger rod locking portion 30) and a plunger portion (shaft 52) extending a certain distance beyond the container rear end portion (Figure 4b) and comprising an outer stop arrangement (disc-shaped proximal end 50), so that when the plunger, comprising a connection portion (thread 53) in a discharge state is pushed forward to the front position of the plunger in said container (Figures 5a-5b), the locking flange arrangement (disc-shaped proximal end 50) of the piston portion is pushed forward, passing the internal stop arrangement of the container (locking nose 34), thereby locking the plunger in the container in a non re-usable state of the syringe (“As shown in FIG. 5b, finally the disc-shaped proximal end 50 of the plunger rod will have slid beyond the front ends of the bevels 35 of the locking noses 34 to be fully accommodated inside the chamber or receiving volume 37 formed by the circumferential side-wall of the plunger rod locking portion 30. More specifically, the disc-shaped proximal end 50 of the plunger rod will have slid into the interspace formed between the bottom sides 36 of the locking noses 34 (see FIG. 2a) and the annular stop surface 32 at the bottom of the plunger rod locking portion 30, so that the resilient locking noses 34 will flex backward into the communication channel 29 to recapture their home position.” [0094]; “locking of the disc-shaped proximal end 50 of the plunger rod 5 by the locking noses 34 reliably prevents unauthorized release of the plunger rod 5 after injection by withdrawal of the disc-shaped proximal end 50 of the plunger rod 5 from chamber or receiving space 37.” [0096]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the syringe of Von Pechmann to include a container rear end portion comprises an internal lock arrangement and a plunger portion extending a certain distance beyond the container rear end portion and comprising an outer stop arrangement, so that when the plunger, comprising a connection portion in a discharge state is pushed forward to the front position of the plunger in said container, the locking flange arrangement of the piston portion is pushed forward, passing the internal stop arrangement of the container, thereby locking the plunger in the container in a non re-usable state of the syringe based on the teachings of Dadachanji to prevent reuse of the syringe after an injection is complete by preventing withdrawal of the plunger (Dadachanji [0096]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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