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 .
This is the first office action in response to the above identified patent application filed on 10/06/2023. Claims 1-15 and 26-30 are currently pending and being examined.
Drawings
Figures 1A-5C should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
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 1-5, 7, 8, 10, 11, 14, 15, 26-28 and 30 are rejected under 35 U.S.C. 102a1 as being anticipated by Diaz et al. (US 2021/0402094).
In regards to Independent Claim 1, and with particular reference to Figures 146-148C, Diaz discloses an injection system 5300 comprising: an injection system body 5320 defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof (as shown in figures 146-148C; pars. 312-316);
proximal 5340 and distal 5390 stopper members disposed in the injection system body, forming a proximal drug chamber 5360 between the proximal and distal stopper members and a distal drug chamber 5370 between the distal stopper member and the distal end of the injection system body;
a plunger member 5330 configured to insert the proximal stopper member relative to the injection system body; and
a valve 5400 forming an openable barrier between the distal needle interface and the distal drug chamber, the valve comprising
an outer member 5420 comprising a distal diaphragm (pliable portion 520 made of rubber; par. 315) which defines a distal opening therein, and
an inner member 5410 comprising a distally extending member configured to fit in and interfere with the distal opening 5422 in the distal diaphragm when the distally extending member is disposed in the distal opening in the distal diaphragm (as shown in figure 148B), wherein the distal diaphragm 5420 is configured to elastically deform (pliable portion made of rubber elastically deforms under pressure) distally away from the inner member 5410 with increased pressure in the distal drug chamber 5370 to allow flow from the distal drug chamber to the distal needle interface (as explained in par. 316).
Regarding dependent Claim 2, Diaz discloses wherein the distal diaphragm 5420 is biased in a closed configuration (shown in figure 148B) in which the distal diaphragm is disposed against the inner member 5410 to position the distal opening 5422 in the distal diaphragm around the distally extending member 5350 of the inner member unless the distal diaphragm is deformed in an open configuration in which the distal diaphragm is disposed away from the inner member (area of diaphragm 5420 which covers the openings 5414 flexes distally which opens opening 5414; this flexing distally separates 5410 from the area of diaphragm 5420 which covers the openings 5414; par. 316; refer to marked-up figure 147 below for clarification; dotted line representing the open configuration).
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Regarding dependent Claim 3, Diaz discloses wherein the distal diaphragm 5420 is configured to convert from the closed configuration (refer to figure 148B) to the open configuration (refer to marked-up figure for the rejection of claim 2 above; dotted line representing the open configuration) when a pressure in the distal drug chamber 5370 is equal to or greater than approximately 10 psi (the injection device is exposed to atmospheric pressure, 14.7 psi; to overcome this pressure so that the open configuration is achieved the applied pressure in the distal drug chamber has to be higher than atmospheric, that is, higher than 14.7psi, which is greater than 10psi).
Regarding dependent Claim 4, Diaz discloses wherein when the distal diaphragm 5420 is in the open configuration (illustrated in marked-up figure above for rejecting claim 2), the distal diaphragm 5420 exerts minimal resistance on fluid flow from the distal drug chamber 5370 through the distal opening 5422 in the distal diaphragm to the distal needle interface (par. 316).
Regarding dependent Claim 5, Diaz discloses the outer member 5420 further comprising a plurality (members 1 and 2) of radially outward annular members (as shown in marked-up figures 148C below) configured to form a fluid-tight seal between the outer member and an inner surface of the injection system body.
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Regarding dependent Claim 7, Diaz discloses the outer member 5420 further comprising a distally extending ring (as shown in marked-up figure below) configured to provide a space for the distal diaphragm to deform distally (deform in the direction X; illustrated by the dotted line) to convert from the closed configuration to the open configuration (par. 316).
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Regarding dependent Claim 8, Diaz discloses the outer member 5320 defining an annular groove (as shown in the marked-up figure below) configured to secure the inner member in the outer member.
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Regarding dependent Claim 10, Diaz discloses wherein the inner member 5410 defines a proximal opening 5414, and wherein the distal diaphragm 5420 interferes fluid flow through with the proximal opening 5414 when the distal diaphragm 5420 is in the closed configuration (as shown in figure 148B; par. 316).
Regarding dependent Claim 11, Diaz discloses wherein the outer member 5420 is formed from a deformable material (rubber; par. 315), and wherein the inner member 5410 is formed from a rigid material (plastic; par. 314.
In regards to Independent Claim 14, and with particular reference to Figures 146-148C, Diaz discloses an injection system 5300, comprising:
an injection system body 5320 defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof (as shown in figures 146-148C; pars. 312-316);
proximal 5340 and distal 5390 stopper members disposed in the injection system body, forming a proximal drug chamber 5360 between the proximal and distal stopper members and a distal drug chamber 5370 between the distal stopper member and the distal end of the injection system body;
a plunger member 5330 configured to insert the proximal stopper member 5340 relative to the injection system body 5320;
a fluid conveying member 5350 removably coupled to the distal needle interface and having a middle opening 5352 disposed adjacent a distal end of the syringe body (pars. 312-316); and
a valve 5400 forming an openable barrier between the middle opening 5352 and the distal drug chamber (5370; refer to figure 147), the valve comprising
an elastic diaphragm 5420 defining a diaphragm opening 5422 therein and disposed around the fluid conveying member (5350; figure 147 ) adjacent the middle opening 5352 therein, and
a seal (portion of diaphragm 5420 covering the openings 5414; figures 148A-148C) around the diaphragm opening 5422 configured to prevent fluid flow from the distal drug chamber 5370 through the middle opening 5352 of the fluid conveying member 5350 when the elastic diaphragm is in a closed configuration (par. 316),
wherein the elastic diaphragm 5420 is configured to elastically deform (pliable portion 520 made of rubber; par. 315) into an open configuration with increased pressure in the distal drug chamber to move the seal distally relative to the fluid conveying member to allow flow from the distal drug chamber through the middle opening of the fluid conveying member (as explained in par. 316).
Regarding dependent Claim 15, Diaz discloses wherein the elastic diaphragm 5420 (par. 315) is biased in the closed configuration (figure 148B) in which the seal (portion of diaphragm 5420 covering the openings 5414; figures 148A-148C) is disposed around the fluid conveying member 5350 proximal of the middle opening 5352 unless the elastic diaphragm is deformed into the open configuration in which the elastic diaphragm is disposed at least partially distal of the middle opening (area of diaphragm 5420 which covers the openings 5414 flexes distally which opens opening 5414; this flexing distally separates 5410 from the area of diaphragm 5420 which covers the openings 5414; par. 316; refer to marked-up figure 147 for the rejection of claim 2 above for clarification; dotted line representing the open configuration).
In regards to Independent Claim 26, and with particular reference to Figures 146-148C, Diaz discloses an injection system 5300, comprising:
an injection system body 5320 defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof (as shown in figures 146-148C; pars. 312-316);
a stopper member (5340 or 5390) disposed in the injection system body, forming a drug chamber 5370 between the stopper member 5390 and the distal end of the injection system body 5320;
a plunger member 5330 configured to insert the stopper member relative to the injection system body;
a needle hub assembly (assembly shown in figure 147) coupled to the distal needle interface, the needle hub assembly comprising
a needle hub (hub shown but not labeled in figure 147; hub supporting the distal end of the needle) coupled to the distal needle interface, and
a needle member 5350 removably coupled to the needle hub (the teeth shown in figure 147 indicates the needle is removable by unscrewing) and having a middle opening 5352 disposed adjacent the distal end of the injection system body; and
a valve 5400 forming an openable barrier between the middle opening 5352 and the drug chamber 5370, the valve comprising an elastic diaphragm 5420 having an circumferentially inward facing surface defining a diaphragm opening 5422 therein and disposed around the needle member proximal of the middle opening (5352; refer to figure 147) therein,
wherein the circumferentially inward facing surface is configured to form a seal (portion of diaphragm 5420 covering the openings 5414; figures 148A-148C) around the with the needle member 5350 to prevent fluid flow from the drug chamber to the middle opening of the needle member when the elastic diaphragm is in a closed configuration (par. 316),, and
wherein the elastic diaphragm is configured to elastically deform (pliable portion 520 made of rubber; par. 315) into an open configuration with increased pressure in the drug chamber to deform the elastic diaphragm distally relative to the needle member to move the circumferentially inward facing surface away from the needle member to allow flow from the drug chamber 5370 to the middle opening 5352 of the needle member 5350, as explained in par. 316.
Regarding dependent Claim 27, Diaz discloses wherein the needle member 5350 is made from a metal (pars. 239, 261, 262, 302).
In regards to Independent Claim 28, and with particular reference to Figures 146-148C, Diaz discloses an injection system 5300, comprising:
an injection system body 5320 defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof (as shown in figures 146-148C; pars. 312-316);
a stopper member 5390 disposed in the injection system body, forming a drug chamber 5370 between the stopper member and the distal end of the injection system body;
a plunger member 5330 configured to insert the stopper member relative to the injection system body; and
a valve 5400 forming an openable barrier (valve openable when pressure is applied and portion 5420 separates from portion 5410 unblocking/opening openings 5414 allowing fluid from the drug chamber 5370 into the needle assembly 5350; par. 316) between the distal needle interface and the drug chamber, the valve comprising
an outer member 5420 comprising a diaphragm (pliable portion 520 made of rubber; par. 315) which defines a diaphragm opening 5422 therein, and
an inner member 5410 configured to fit in the diaphragm opening (portion 5416 extends into the opening 5422), wherein the inner member is configured to interfere with the diaphragm opening when the diaphragm is in a closed configuration (as shown in figure 148B when portion 5420 is in contact with portion 5410) and the inner member is disposed in the diaphragm to form the openable barrier between the distal needle interface and the drug chamber (valve openable when pressure is applied and portion 5420 separates from portion 5410 unblocking/opening openings 5414 allowing fluid from the drug chamber 5370 into the needle assembly 5350; par. 316), and
wherein the diaphragm 5420 is configured to elastically deform (pliable portion made of rubber elastically deforms under pressure) into an open configuration with increased pressure in the drug chamber to deform the elastic diaphragm distally away from the stopper member to allow the inner member to separate from the diaphragm to allow flow from the drug chamber to the distal needle interface (area of diaphragm 5420 which covers the openings 5414 flexes distally which opens opening 5414; this flexing distally separates 5410 from the area of diaphragm 5420 which covers the openings9 5414; par. 316; refer to marked-up figure 147 below for clarification).
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Regarding dependent Claim 30, Diaz discloses wherein the inner member 5410 comprises a smaller radius portion R1 disposed longitudinally between proximal and distal larger radius portions (R2, R3; as shown in the marked-up figure below).
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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.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Diaz.
Diaz teaches the invention as claimed and as disclosed above including wherein the inner member 5410 is made from a rigid material (par. 314 teaches for example plastic which implies not exclusively plastic but can be other materials since plastic is simply an example).
Diaz does not teach the rigid material is a metal.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made Diaz’s inner member from a metal since it has been held that the selection of a known material (in the present case, metal) based on its suitability for its intended use (durability; life span) would have been an obvious extension of prior art teachings. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), MPEP 2144.07.
Allowable Subject Matter
Claims 6, 9, 12 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following reference(s) are also relevant for at least claims 1, 14, 26 and 28.
Diaz et al. (US 2023/0248913). Particularly refer to figures 12-22; valve 820 or 1520 or 1920.
Szapiro et al. (US 2019/0117901). Particularly refer to figures 8-21; valve 3/4.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
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, Phutthiwat Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H Rodriguez/Primary Examiner, Art Unit 3741