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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 07/23/2025. Claims 1-20 are currently pending and being examined.
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 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.
Election/Restrictions
Claims 7, 8, and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/23/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “coupling a seal first end” in line 2. Examiner suggests reciting “a coupling on a seal first end”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5 recites “wherein the coupling the seal first end” in line 1. Examiner suggests reciting “wherein the coupling on the seal first end”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5 recites “such that seal first end is integral” in line 2. Examiner suggests reciting “such that the seal first end is integral”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Claim 6 recites “wherein the coupling the seal second end” in line 1. Examiner suggests reciting “wherein the coupling on the seal second end”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Claim 6 recites “such that seal second end is integral” in line 2. Examiner suggests reciting “such that the seal second end is integral”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Claim 9 recites “coupling the seal second end” in line 5. Examiner suggests reciting “coupling on the seal second end”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Claim 16 recites “the first seal end” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the seal first end”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Claim 16 recites “the second seal end” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the seal second end”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-4, 9, 12-16, and 18 are rejected under 35 U.S.C. 102(a) as being anticipated by Zhang (CN 113181475).
In reference to independent claim 1, Zhang discloses a structure capable of the method, comprising: coupling a seal first end (bottom of 8 fig 5) of a syringe seal (8, fig 1) to a syringe barrel (1) of a syringe (fig 1),
wherein the syringe barrel (1) comprises a barrel body (body of 1) spanning between a barrel needle end (end holding the needle 2) and a barrel plunger end (top end of 1); and
coupling a seal second end (top of 8 fig 5) of the syringe seal (8) to a syringe plunger of the syringe,
wherein the syringe plunger (5) is disposed within the syringe barrel (1), wherein the syringe seal (8) is coupled to the syringe barrel (via groove 82, fig 5) and the syringe plunger (via 81 of 8, fig 5) of the syringe such that the syringe seal (8) must be at least one of broken or decoupled from at least one of the syringe barrel or the syringe plunger in order to translate the syringe plunger within the syringe barrel past a tension point (8 must be removed from the syringe in order for the plunger 5 to be extended from the barrel 1 and be used).
In reference to dependent claim 12, Zhang discloses a syringe (fig 1), comprising: a syringe barrel (1); a syringe plunger (5) comprising a plunger body (body of 5) spanning between a plunger proximal end (bottom of 5) and a plunger distal end (top of 5), wherein the syringe plunger (5) is disposed in the syringe barrel (1) such that the plunger proximal end (bottom of 5) is disposed within the syringe barrel (1) and the plunger distal end is outside the syringe barrel (top of 5 is outside of the barrel 1); and a syringe seal (8) comprising and spanning between a seal first end (bottom of 8 fig 5) and a seal second end (top end of 8 fig 5), wherein the seal first end (bottom of 8) is coupled to the syringe barrel (via groove 82, fig 5) and the seal second end (top of 8) is coupled to the syringe plunger (via 81 of 8, fig 5).
In reference to dependent claim 20, Zhang discloses a syringe kit (fig 1), comprising: a syringe barrel (1); a syringe plunger (5) comprising a plunger body spanning between a plunger proximal end (bottom of 5) and a plunger distal end (top of 5), wherein the syringe plunger (5) is configured to be disposed in the syringe barrel such that the plunger proximal end is disposed within the syringe barrel (1) and the plunger distal end is outside the syringe barrel (top of 5 is outside of the barrel 1); and a syringe seal (8) comprising and spanning between a seal first end (bottom of 8 fig 5) and a seal second end (top end of 8 fig 5), wherein the seal first end is configured to be coupled to the syringe barrel (via groove 82, fig 5) and the seal second end is configured to be coupled to the syringe plunger (via 81 of 8, fig 5).
In reference to dependent claim 2, Zhang discloses a structure capable of the method of claim 1, wherein the coupling the seal first end (bottom of 8) to the syringe barrel (1) comprises coupling the seal first end to the syringe barrel (1) at or proximate the barrel plunger end (groove 82 of 8 couples the seal to the barrel and is located at the proximate end of the barrel).
In reference to dependent claim 3, Zhang discloses a structure capable of the method of claim 2, wherein the syringe barrel (1) at the barrel plunger end comprises a barrel flange (11) protruding radially from the barrel body (flange 11 extends radially from the barrel 1).
In reference to dependent claim 4, Zhang discloses a structure capable of the method of claim 3, wherein the coupling the seal first end (bottom of 8) to the barrel plunger end of the syringe barrel (1) comprises coupling the seal first end to the barrel flange (fig 1 shows 8 coupling the bottom of 8, the first end to the barrel flange 11).
In reference to dependent claim 9, Zhang discloses a structure capable of the method of claim 1, wherein the syringe plunger (5) comprises a plunger body spanning between a plunger proximal end (bottom of 5) configured to be disposed within the syringe barrel (1) and a plunger distal end (top of 5) configured to disposed outside of the syringe barrel (1), wherein the plunger distal end comprises a plunger flange (51) protruding radially from the plunger body (fig 1 shows 51 protruding radially from the plunger), wherein the coupling the seal second end (top of 8) to the syringe plunger comprises coupling the seal second end to the plunger flange (8 couples to the plunger flange via the groove 81).
In reference to dependent claim 13, Zhang discloses the syringe of claim 12, wherein the syringe barrel (1) comprises a barrel body spanning between a barrel needle end (bottom of 1) and a barrel plunger end (top of 1), wherein the seal first end (bottom of 8) is coupled to the syringe barrel (1) at or proximate the barrel plunger end (8 is coupled to the top of 1, fig 1).
In reference to dependent claim 14, Zhang discloses the syringe of claim 13, wherein the syringe barrel (1) at the barrel plunger end comprises a barrel flange (11) protruding radially from the barrel body (11 protrudes radially from 1).
In reference to dependent claim 15, Zhang discloses the syringe of claim 14, wherein the first seal end (bottom of 8) is coupled to the barrel flange (fig 1 shows the seal 8 coupled to the flange 11 via the groove 82).
In reference to dependent claim 16, Zhang discloses the syringe of claim 15, wherein the plunger distal end comprises a plunger flange (51) protruding radially from the plunger body, wherein the second seal end clamp is coupled to the plunger flange (fig 1 shows the seal 8 coupled to the flange 51 via the groove 81).
In reference to dependent claim 18, Zhang discloses the syringe of claim 12, wherein the syringe seal (8) is configured such that, in response to the seal first end (bottom of 8) being coupled to the syringe barrel (8 is coupled to 1 via the groove 82) and the seal second end (bottom of 8) being coupled to the syringe plunger (8 is coupled to 1 via the groove 81), the syringe seal (8) must be at least one of broken or decoupled from at least one of the syringe barrel or the syringe plunger in order to translate the syringe plunger within the syringe barrel past a tension point (8 must be decoupled in order for the plunger to move out from the barrel in order to use).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 5, 6, 11, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 113181475) in view of Heinz (USPAP 2004/0116858).
In reference to dependent claim 5, Zhang discloses the structure capable of the method of claim 1, Zhang further discloses coupling the seal first end (bottom side of 8, fig 1) to the syringe barrel (1, fig 3) comprises attaching, such that seal first end is fixed with the syringe barrel (bottom end of 8 attaches to the plunger via the groove 82, fig 5).
Zhang is silent to melting or welding, such that the parts are integral.
Heinz, a similar seal for use with syringes, teaches melting or welding, such that the parts are integral (para 0007 discloses “the frangible web may be directly welded to the connection-side end of the syringe, or less complicated with regard to manufacturing technology, the frangible web in the known manner may be connected to a fixation component which is then connected to the connection end of the syringe by welding” once welded the components are integral).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the welding technique taught in Heinz in the syringe of Zhang so “that even with an unfavorable dimensioning of the frangible web it is always ensured that the break-off location is formed by the frangible web and not by other components or the weld seam.” Para 0008; Heinz.
In reference to dependent claim 6, Zhang in view of Heinz discloses the structure capable of the method of claim 1, Zhang further discloses wherein the coupling the seal second end (top side of 8 fig 1) to the syringe plunger (5) comprises attaching such that seal second end is fixed with the syringe plunger (top end of 8 attaches to the plunger via the groove 81, fig 5), however
Zhang is silent to melting or welding, such that the parts are integral.
Heinz, a similar seal for use with syringes, teaches melting or welding, such that the parts are integral (para 0007 discloses “the frangible web may be directly welded to the connection-side end of the syringe, or less complicated with regard to manufacturing technology, the frangible web in the known manner may be connected to a fixation component which is then connected to the connection end of the syringe by welding” once welded the components are integral).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the welding technique taught in Heinz in the syringe of Zhang so “that even with an unfavorable dimensioning of the frangible web it is always ensured that the break-off location is formed by the frangible web and not by other components or the weld seam.” Para 0008; Heinz.
In reference to dependent claim 11, Zhang discloses a structure capable of the method of claim 1, however
Zhang is silent to breaking the syringe seal between the seal first end and the seal second end to use the syringe.
Heinz, a similar syringe, teaches breaking the seal (16, fig 3) between the seal first end and the seal second end to use the syringe (breaking the frangible web 16 must be done in order to use the syringe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the welding technique taught in Heinz in the syringe of Zhang “to improve a tamper-evident closure of the initially mentioned type to the extent that on the one hand is may be manufactured inexpensively, but that on the other hand is guarantees the integrity of the closure as long its frangible web is intact” Para 0006; Heinz.
In reference to dependent claim 17, Zhang discloses the syringe of claim 16, however
Zhang does not teach wherein the seal first end is integral with the barrel flange and the seal second end is integral with the plunger flange.
Heinz, a similar syringe, teaches wherein the seal first end (left side of 16, fig 3) is integral with the one component and the seal second end (right side of 16, fig 3) is integral with the other component (para 0007 discloses “the frangible web may be directly welded to the connection-side end of the syringe, or less complicated with regard to manufacturing technology, the frangible web in the known manner may be connected to a fixation component which is then connected to the connection end of the syringe by welding” once welded the components are integral).
In reference to dependent claim 19, Zhang discloses the syringe of claim 12, however
Zhang does not teach wherein at least one of: the seal first end is at least one of melted or welded to the syringe barrel; or the seal second end is at least one of melted or welded to the syringe plunger .
Heinz, a similar syringe, teaches at least one of: the seal first end (one side of 16) is at least one of melted or welded to the syringe (syringe barrel 1, fig 3; para 0007 discloses “the frangible web may be directly welded to the connection-side end of the syringe, or less complicated with regard to manufacturing technology, the frangible web in the known manner may be connected to a fixation component which is then connected to the connection end of the syringe by welding” once welded the components are integral); or the seal second end is at least one of melted or welded to the syringe plunger.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the welding technique taught in Heinz in the syringe of Zhang so “that even with an unfavorable dimensioning of the frangible web it is always ensured that the break-off location is formed by the frangible web and not by other components or the weld seam.” Para 0008; Heinz.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lum (USPAP 2011/0046559) discloses a syringe.
Schiff (USPAP 2013/0082057) discloses a syringe assembly.
Cummins (USPAP 2006/0173415) discloses a syringe adapter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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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/C.W.N/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783