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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/28/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character in FIGURE 1 not mentioned in the description: 14.
The drawings are objected to because in FIGURE 4, the line indicating the proximal support surfaces 22 is pointing towards the distal end of the body 10, but in FIGURE 5A and FIGURE 6, the line of 22 is pointing to a radially extending part near the proximal end of the body 10. It is unclear to the examiner which figure(s) indicate the correct location of the proximal support surfaces.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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:
On pg. 6 line 10 and pg. 11 line 24, the specification uses “he” to describe a user of the device. This is inconsistent language, as previously in the specification a user of the device was referred to as “the user”. The examiner suggest modifying the user of “he” to “the user” for continuity purposes. Appropriate correction is required.
On pg. 7 line 13, the specification uses the reference number 17 to describe “the protrusions”. Previously, the reference number 17 was used to describe “the first locking member”. The examiner acknowledges on pg. 7 lines 11-12 the specification explains “the first locking member comprises one or more protrusions”, however every other use of the reference number 17 throughout the specification is describing “the first locking member”. Therefore, the examiner suggest modifying “the protrusions” to “the first locking member” for continuity purposes. Appropriate correction is required.
On page 10 lines 23-24 the specification states “With reference to figure 6, the second locking members 19…”. However, in the drawings, there is no reference to “the second locking members 19” in FIGURE 6. The examiner acknowledges in other figures, the reference number 19 is used to identify “the second locking member”, but as for FIGURE 6, there is no reference to 19, nor can “the second locking member” be seen in that view.
Claim Objections
Claim 1 is objected to because of the following informalities: In the fifteenth line of the claim, the claim states “the locking member”. The examiner acknowledges the only other reference to a locking member in the claim is in line 8 “at least one first locking member”, and therefore it can be reasonably inferred that “at least one first locking member” and “the locking member” are the same. However, because in the device as a whole there exist a “second locking member”, the examiner suggest modifying “the locking member” to be “the at least one first locking member” for clarity purposes. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: In the third line of the claim, the claim references “a plunger rod”. However, “a plunger rod” is again referenced in the eleventh line of the claim. It is confusing to the examiner if these are the same plunger rods or different. The examiner suggest, if the plunger rods are the same, modifying “a” to “the” in the eleventh line reference. If the plunger rods are different, the examiner suggest adding some identifying detail to either reference to differentiate. For the purposes of examination, the examiner will interpret both “a plunger rod” to be the same.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“at least one frangible member configured to” in claim 1 has been interpreted as structurally parts that are “breakable by applying an activation force in axial direction on the plunger rod” (pg. 8 lines 15-17). These parts “can be in the shape of one or more bridges” (pg. 8 line 18).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barrelle (EP 1381414 B1).
Regarding claim 1, Barrelle discloses a safety system (syringe 1) for a medical injection device (syringe body 2) comprising a barrel (FIG. 2, barrel of syringe body 2) containing a medical solution (“Figure 1 is a perspective view, in the form of a syringe, before injection of the product that contains the syringe”, the examiner reasonably interprets the “product” to be a medical solution), a needle (injection needle 11) extending from the distal end of the barrel (FIG. 2), and a stopper (piston 3) adapted to be pushed by a plunger rod (piston rod 4) for expelling the medical solution though the needle ("the rod 4 to slide the piston 3 in the body 2"), said safety system comprising:
a body (holster or case 5) configured for holding the medical injection device (FIG. 2), the medical injection device being movable relative to the body ("case and body being movable relative to each other") between an initial distal position (FIG. 1, "a position of use of the device") in which the needle protrudes distally from the body (FIG. 1, "in which the needle of the syringe is exposed") and a final safety position (FIG. 10, "a safety position") in which the needle is surrounded by the body (FIG. 10, "in which this needle is surrounded by the case so as to prevent any risk of puncture or cutting"), the body comprising at least one first locking member (tab or wedge or legs 30) configured to releasably lock the medical injection device to the body in the initial distal position ("The legs 30 and the bosses 31 allow for them, as well as this is deduced from FIG. 4, to wedge laterally syringe bodies 2 of different outside diameters, the legs 30 deforming if necessary towards the outside so as to allow adequate erasure of the bosses 31"), and
a plunger rod (piston rod 4) movable relative to the body (FIG.2 to FIG. 10, piston rod 4 has moved) and configured to drive the stopper in distal direction until abutment onto a distal end of the barrel ("At the end of the injection, the piston 3 abuts against the bottom of the syringe body 2"), said plunger rod being axially collapsible between an initial extended configuration and a final retracted configuration (FIG. 2 to FIG. 10, "the proximal one 16 has a tubular shape adapted to receive the part 15 sliding"),
the plunger rod and the locking member being configured so that when the stopper abuts at the distal end of the barrel, a safety activation force exerted onto the plunger rod in distal direction collapses the plunger rod in the final retracted configuration ("at least one ruptible bridge connects the two telescopic portions of the piston rod, this or these bridges being able to break beyond a threshold of opposing forces exerted on said bearing portion and said head, this threshold being greater than the force required to move the piston but less than the opposing forces that a user is likely to exert manually on said bearing portion and said head"), thereby causing the body to move to the final safety position ("The rupture of the ruptible bridge(s) generates a relative movement the body of the syringe and the protective case, such as this body of syringe and this case are brought into a safety position at the end of this jerk").
Regarding claim 2, Barrelle discloses the plunger rod comprises a first axial portion (FIG. 2, part 16) having an inner diameter (Annotated on FIG. 3 below) and a second axial portion (FIG. 2, part 15) having an outer diameter smaller than the inner diameter of the first axial portion (FIG. 10, part 15 is within part 16, so therefore it must have a smaller OD than the ID of part 16; FIG. 3 shows bridges 20 that hold part 15 and part 16 apart, but when bridges collapse, part 15 slides within part 16), the plunger being collapsible by application of the safety activation force to drive the second axial portion into the first axial portion (FIG. 2 to FIG. 10, "the proximal one 16 has a tubular shape adapted to receive the part 15 sliding").
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Regarding claim 3, Barrelle discloses in the initial extended configuration, the first axial portion and the second axial portion of the plunger rod form a single piece (FIG. 2, part 15 and part 16 appear as a whole rod), said first and second portions being connected by at least one frangible member (FIG. 3, bridges 20) configured to break under the safety activation force ("at least one ruptible bridge connects the two telescopic portions of the piston rod, this or these bridges being able to break beyond a threshold of opposing forces exerted on said bearing portion and said head, this threshold being greater than the force required to move the piston but less than the opposing forces that a user is likely to exert manually on said bearing portion and said head").
Regarding claim 4, Barrelle discloses the first axial portion and the second axial portion of the plunger rod are separate pieces in frictional engagement with each other in the initial extended configuration (FIG. 3, bridges 20 hold parts 15, 16 in frictional engagement), said frictional engagement being configured to be released under the safety activation force ("The rupture of the ruptible bridge(s) generates a relative movement the body of the syringe and the protective case, such as this body of syringe and this case are brought into a safety position at the end of this jerk"; “These bridges 20 are strong enough to withstand the force it is necessary to exert on the rod 4 to slide the piston 3 in the body 2 but are fit to break beyond a force threshold antagonists may be exerted on the ring 6”).
Regarding claim 5, Barrelle discloses the body comprises a pair of radially opposite proximal support surfaces (FIG. 2 and FIG. 7, arms 55) for receiving a proximal flange of the medical injection device (FIG. 2, proximal flange 12 received and fit within arms 55).
Regarding claim 6, Barrelle discloses the body comprises a pair of radially opposite lateral recesses between the support surfaces for exposing opposite parts of a distal face of the flange (Annotated on FIG. 1 below; FIG. 6, FIG. 8, and FIG. 9 are all axial view, but still show and opening in case 5 around connecting bodies 56 on both sides).
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Regarding claim 7, Barrelle discloses the initial distal position, a proximal length between the flange and a proximal end of the body is greater than a distal length between a distal end of the body and a tip of the needle (Annotated on FIG. 2 below, visually the length of the “distal length” line is smaller than the length of the “proximal length” line; Further, in the applicant’s specification, there is no criticality placed on the need for the proximal length to be longer than the distal length).
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Regarding claim 12, Barrelle discloses the body further comprises at least one second locking member (FIG. 11, chamfer 52 and ribs 53) for locking the medical injection device to the body in the final safety position (FIG. 11, flange 24 gets locked into ribs 53, which locks the case 5 into a safety position).
Regarding claim 15, Barrelle discloses a medical injection system comprising a safety system according to claim 1 (system 1) and a medical injection device arranged in the body (FIG. 2, syringe body 2).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Barrelle as applied to claim 1 above, and further in view of Canton et al. (United States Patent Application Publication No. US 2012/0157962 A1; herein Canton).
Regarding claim 8, Barrelle discloses a minimal collapsing force is required for collapsing the plunger rod (“these bridges being able to break beyond a threshold of opposing forces exerted on said bearing portion and said head, this threshold being greater than the force required to move the piston”).
Barrelle does not disclose and/or a minimal unlocking force is required for unlocking the medical injection device, the minimal unlocking force being different from the minimal collapsing force. However, Canton teaches and/or a minimal unlocking force is required for unlocking the medical injection device ([0007], “a locking member adapted to move between a locked position and an unlocked position, and exerting an unlocking force on a releasing member”), the minimal unlocking force being different from the minimal collapsing force ([0038], there is a difference between an unlocking force and an injection force being taught, which can be translated to differentiate between the instant application’s minimal unlocking force and minimal collapsing force). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the safety system disclosed by Barrelle to include a minimal unlocking force as taught by Canton in order to give the user control of the system transitioning between states, making for safer handling of the system ([0009]).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Barrelle as applied to claim 1 above, and further in view of Hsich et al. (United States Patent Application Publication No. US 2005/0148944 A1; herein, Hsich).
Regarding claim 9, Barrelle does not disclose the body comprises a proximal lid comprising a through hole for the passage of the plunger rod, the proximal lid being configured for retaining the medical injection device in the final safety position. However, Hsich teaches the body comprises a proximal lid (retainer 36) comprising a through hole for the passage of the plunger rod (FIG. 1, notch 35 functions in the same manner as a through hole), the proximal lid being configured for retaining the medical injection device in the final safety position (FIG. 4, [0022], retainer 36 secures the finger flange 42 while the outer sleeve 10 is pull out from the inner sleeve 20 and locked in position to cover the contaminated needle 46). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the safety system disclosed by Barrelle to include a proximal lid for retaining the medical injection device as taught by Hsich in order to attach the syringe safety sleeve to the finger flange and accommodate free movement of the syringe plunger ([0018]).
Regarding claim 10, in the modified system of Barrelle, Barrelle does not disclose the proximal lid and the body are made in one piece. However, Hsich teaches the proximal lid and the body are made in one piece (FIG. 1 retainer 36 is connected to inner sleeve 20). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified safety system disclosed by Barrelle to have the proximal lid and body be one piece as taught by Hsich in order to attach the syringe safety sleeve to the finger flange ([0018]).
Regarding claim 11, in the modified system of Barrelle, Barrelle does not disclose the proximal lid is connected to the body by means of a hinge. However, Hsich teaches the proximal lid is connected to the body by means of a hinge (FIG. 1, barrel connector 30 connects retainer 36 and inner sleeve 20). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified safety system disclosed by Barrelle to connect the proximal lid and body by hinge as taught by Hsich in order to attach the syringe safety sleeve to the finger flange ([0018]), while also keeping all parts together.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Barrelle as applied to claim 12 above, and further in view of Perez et al. (United States Patent No. US 7,041,085 B2; herein, Perez).
Regarding claim 13, Barrelle does not disclose the body is made of a transparent material. However, Perez teaches the body is made of a transparent material (col. 7 lines 49-54, “Both the body 20 and the shield 60 are...preferably clear and substantially colorless”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the safety system disclosed by Barrelle to have the body be transparent material taught by Perez in order to facilitate observation of the pre-filled syringe received therein (col. 7 lines 49-54).
Regarding claim 14, Barrelle does not disclose the body is made of polyethylene or polypropylene. However, Perez teaches the body is made of polyethylene or polypropylene (col. 7 lines 49-54, “Both the body 20 and the shield 60 are generally molded from plastic, such as polypropylene”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the safety system disclosed by Barrelle to have the body be made of polypropylene ore polyethylene as taught by Perez in order to remain resilient against injection handling and forces, as molded plastic has the ability to do (col. 19 lines 64-65).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Petit (United States Patent Application Publication No. US 2021/0162130 A1) is considered relevant prior art with regards to a fluid injection device movable between a non-projection position and projection position.
Barrelle (FR 2821561 A1) is considered relevant prior art with regards to a syringe with a telescopic piston rod.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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