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 .
Response to Amendment
The reply filed 4/29/2026 amends the claim set filed 10/18/2023. However, the Non-Final Rejection mailed 1/30/2026 examined (what appeared to be) the claim set filed 10/14/2025. Upon further investigation, it appears that the claim set filed 10/14/2025 was incorrectly labeled by support staff when it was received and these claims (1) actually pertain to NPL #7 on the IDS filed 10/14/2025 and (2) were not intended to be filed as claims for examination in the present application. Therefore, the statement of reasons for allowance set forth in the last Office Action is withdrawn because the claims filed 4/29/2026 do not contain the subject matter that was indicated as allowable in the Non-Final Rejection1.
Information Disclosure Statement
The information disclosure statement filed 4/30/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein that has been crossed out has not been considered. Specifically, NPL citation #2 is not in the English language and neither a translation nor a concise explanation of its relevance has been provided.
Specification
The amendments to the Specification filed 4/29/2026 are acceptable and overcome the objection set forth in the last Office Action.
Terminal Disclaimer
The terminal disclaimer filed on 4/29/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of US Patents 10,864,330 and 11,724,042 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 11 is objected to because of the following informalities: The term “comprises” on line 5 is grammatically incorrect. Accordingly, the term “comprises” on line 5 should be replaced with the term comprise”. Appropriate correction is required.
Claims 14 and 15 are objected to because of the following informalities: The term “past” on line 2 of each of claims 14 and 15 should be replaced with the term “pass” in order to be grammatically correct. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: On line 2, the phrase “the distal drug chamber” lacks proper antecedent basis but it is clear that this was intended to refer to the “distal medicine chamber” of claim 18. Accordingly, line 2 of claim 19 should be amended to recite “the distal [[drug]] medicine chamber” to match the language of claim 18. On line 4, the term “a” in the phrase “a first medicine component” should be replaced with the term “the” since this component has already been introduced in claim 18. 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 18-20 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 18 is indefinite for the following reasons:
Line 5 recites the term “thereof”, but it is unclear whether this term is intended to refer to the “cylindrical injection body”, the “proximal opening”, or the “distal needle interface”. For the sake of examination, the term “thereof” is interpreted as referring to the “cylindrical injection body”. Accordingly, it is suggested to amend line 5 to replace the term “thereof” with the phrase “of the cylindrical injection body”.
Line 19 recites the phrase “the distal stopper members”. Since only one “distal stopper member” has been introduced earlier in the claim but “proximal and distal stopper members” have been introduced earlier in the claim, it is unclear if “the distal stopper members” was intended to recite “the distal stopper member[[s]]” or “the proximal and distal stopper members”. For the sake of examination, line 19 is interpreted as intending to refer to “the distal stopper member”. Accordingly, it is suggested to amend line 19 to replace the term “members” with the term “member”.
Line 25 recites the phrase “the needle proximal feature”. This feature lacks proper antecedent basis since this is the first time it is being introduced. Further, it is unclear if these feature belongs to the needle or is just intended to engage with the needle. For the sake of examination, this feature is interpreted as being a component of the needle. Accordingly, it is suggested to amend lines 13-14 to recite “a needle member having a distal needle tip, a medicine passage, a plurality of transfer openings, [[a]] a proximal end, and a needle proximal end feature”.
Claims 19 and 20 are rejected due to their dependence on claim 18.
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 1-4, 11, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz et al. (WO 2015/164839)2 in view of Elliott (US Pat 3,980,083).
Re claim 1, Diaz discloses a system (as seen in Fig 54A-54P; it is noted that all reference characters cited below refer to Fig 54K unless otherwise noted) for mixing drug products and injecting (Para 125), comprising: a cylindrical injection body 34 defining a proximal opening (to the right in Fig 54K) and a distal needle interface 602 (not clearly seen in Fig 54A-54P, but clearly seen in Fig 48B; Para 117, “slightly recessed radial portion (602) of the syringe body”) at a distal end (to the left in Fig 54K) of the cylindrical injection body; proximal and distal stopper members 32,36 disposed in the cylindrical injection body (as seen in Fig 54K), forming a proximal drug chamber (within which first medicine component 525 is stored) between the proximal and distal stopper members (as seen in Fig 54K) and a distal drug chamber (within which second medicine component 254 is stored) between the distal stopper member and the distal end of the cylindrical injection body (as seen in Fig 54K); a plunger member 44 defining a plunger interior (as seen in Fig 54B) and configured to insert the proximal stopper member relative to the cylindrical injection body (Para 125); a needle hub assembly (as seen in Fig 54C,54D) coupled to the distal needle interface of the cylindrical injection body (Para 117), the needle hub assembly including a needle (seen in Fig 54A, having tip 48 and needle proximal end feature 50) having a needle proximal end feature 50 (Fig 54A,54G), a hub 606 (Fig 56C,54D), and a needle latching member 634 (Fig 54D) configured to couple the needle to the hub (Para 119), wherein first and second sizes of the respective proximal and distal drug chambers can be modified by movement of the proximal and distal stopper members relative to the cylindrical injection body (as seen in Fig 54K-54O, Para 125). Diaz does not disclose that the distal stopper member (a) includes a funnel disposed at a distal end thereof, the funnel tapering in a proximal direction, such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel and (b) comprises a proximal gate having a closed configuration wherein the needle proximal end feature cannot pass through the proximal gate, and an open configuration wherein the needle proximal end feature can pass through the proximal gate.
Elliott, however, teaches a system 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1,6-8 unless otherwise noted) comprising a cylindrical injection body 12, a distal stopper member 14 disposed in the cylindrical injection body, and a needle member 16+18, wherein the distal stopper member includes a funnel 84 (best seen in Fig 6,15) disposed at a distal end thereof (as seen in Fig 6,15), the funnel tapering in a proximal direction such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel (as seen in Fig 15), and a proximal gate 82+92+86 having a closed configuration (seen in Fig 6) wherein the needle proximal end feature cannot pass through the proximal gate (Col 4, Lines 29-30), and an open configuration (seen in Fig 8) wherein the needle proximal end feature can pass through the proximal gate (Col 5, Lines 3-5). Elliott teaches that the funnel acts as an entryway for the needle into the plunger (Col 4, Lines 29-33) and the proximal gate acts as a seal to close the cylindrical injection body for storage prior to usage (Col 4, Lines 29-30 and 56-59). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz to include the stopper with a funnel and a proximal gate, as taught by Elliott, for the purpose providing an entryway for the needle into the plunger (Col 4, Lines 29-33) and providing a seal to close the cylindrical injection body for storage prior to usage (Col 4, Lines 29-30 and 56-59), respectively.
Re claim 2, Diaz discloses that the proximal and distal drug chambers respectively contain first and second components 252,254 of a drug to be mixed together prior to injecting into a patient (Para 124).
Re claim 3, Diaz discloses that the system has a transport configuration (seen in Fig 54K; Para 125, “Referring to Figure 54K, an injection assembly is in a stable configuration wherein it may be shipped or brought to an injection patient care scenario”) wherein the needle proximal end feature is disposed in the distal drug chamber (as seen in Fig 54K), a transfer configuration (seen in Fig 54M) wherein the needle proximal end feature has at least partially pierced the distal stopper member and is at least partially disposed in the proximal drug chamber (Para 125, “Referring to Figure 54M, with further advancement, sufficient to stab the proximal end of the needle assembly across the distal stopper member (36), a fluid pathway is formed between the two previously isolated chambers of the syringe body (34), such that the diluent fluid (252) may flow into the proximal mixing port and exit the more distal mixing aperture, to reach the non-liquid medication component (254)”), and a mixed configuration (as seen in Fig 54N) wherein the proximal and distal stopper members are in contact with each other, thereby transferring a first drug component from the proximal drug chamber to the distal drug chamber to mix the first drug component with a second drug component in the distal drug chamber (Para 125, “Figure 54N illustrates that with further insertion until the stopper members (36,32) are immediately adjacent each other, the diluent (252) and previously non-liquid component (254) become mixed to form a medication solution (272)”).
Re claim 4, Diaz discloses that the needle comprises: a distal end opening (at tip 48, Para 64); a middle opening 266 (Fig 54D) disposed in the distal drug chamber when the system is in the transport, transfer, and mixed configurations (Para 124); and a proximal opening 270 (Fig 54D) disposed in the proximal drug chamber when the system is in the transfer configuration (Para 124).
Re claim 11, Diaz discloses that the proximal and distal stopper members each includes a respective opposing surface (the opposing surface of proximal stopper 32 faces to the left in Fig 54K and the opposing surface of distal stopper 36 faces to the right in Fig 54K), wherein the opposing surface of the proximal stopper member faces a distal direction (to the left in Fig 54K), and wherein the opposing surface of the distal stopper member faces a proximal direction (to the right in Fig 54K), and wherein the proximal and distal stopper members comprises respective first and second polymer coatings on the respective opposing surfaces (Para 27, “The system further may comprise a sealant coating applied to at least a portion of the stopper to isolate medicine materials from the stopper. The sealant coating may comprise a PTFE film.”) such that the proximal drug chamber is defined by the cylindrical injection body and the first and second polymer coatings (since Para 27 discloses that the portion of the stoppers that contact the medicine material has the coating).
Re claim 17, Diaz as modified by Elliott in the rejection of claim 1 above disclose all the claimed features with Elliott teaching that the funnel is configured to receive the needle proximal end feature and guide the needle into coaxial alignment with the distal stopper member (as seen in Fig 6). The motivation cited in claim 1 also applies to this claim.
Re claim 18, Diaz discloses a method for mixing and injecting medicine into a patient (Para 125), comprising: providing a system (as seen in Fig 54A-54P; it is noted that all reference characters cited below refer to Fig 54K unless otherwise noted) comprising a cylindrical injection body 34 defining a proximal opening (to the right in Fig 54K) and a distal needle interface 602 (not clearly seen in Fig 54A-54P, but clearly seen in Fig 48B; Para 117, “slightly recessed radial portion (602) of the syringe body”) at a distal end (to the left in Fig 54K) of the cylindrical injection body, proximal and distal stopper members 32,36 disposed in the cylindrical injection body (as seen in Fig 54K), forming a proximal medicine chamber (within which first medicine component 252 is stored) between the proximal and distal stopper members (as seen in Fig 54K) and a distal medicine chamber (within which second medicine component 254 is stored) between the distal stopper member and the distal end of the cylindrical injection body (as seen in Fig 54K), a plunger member 44 defining a plunger interior (as seen in Fig 54B) and configured to insert the proximal stopper member relative to the cylindrical injection body (Para 125), and a needle member (as seen in Fig 54C,54D) having a distal needle tip 48, a medicine passage (“the needle lumen”, Para 125), a plurality of transfer openings 266,270, a proximal end (to the right in Fig 54K), and a needle proximal end feature 50 (Fig 54A,54G); advancing the plunger member to pierce the proximal end of the needle member through the distal stopper member to allow the passage of a first medicine component 252 from the proximal medicine chamber through the medicine passage and into the distal medicine chamber to allow mixing of the first medicine component with a second medicine component 254 in the distal medicine chamber to form a mixed medicine (Para 125, “Fig 54L illustrates insertion movement of the plunger assembly (44), advancing the distal (36) and proximal (32) stopper members relative to the syringe body (34)”, “Referring to Figure 54M, with further advancement, sufficient to stab the proximal end of the needle assembly across the distal stopper member (36), a fluid pathway is formed between the two previously isolated chambers of the syringe body (34), such that the diluent fluid (252) may flow into the proximal mixing port and exit the more distal mixing aperture, to reach the non-liquid medication component (254)”, “Figure 54N illustrates that with further insertion until the stopper members (36,32) are immediately adjacent each other, the diluent (252) and previously non-liquid component (254) become mixed to form a medication solution (272)”); and advancing the plunger member to inject the mixed medicine into a patient (Para 125, “the patient may be injected”). Diaz does not disclose that the distal stopper member (a) includes a funnel disposed at a distal end thereof, the funnel tapering in a proximal direction, such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel and (b) comprises a proximal gate having a closed configuration wherein the needle proximal end feature cannot pass through the proximal gate, and an open configuration wherein the needle proximal end feature can pass through the proximal gate.
Elliott, however, teaches a system 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1,6-8 unless otherwise noted) comprising a cylindrical injection body 12, a distal stopper member 14 disposed in the cylindrical injection body, and a needle member 16+18, wherein the distal stopper member includes a funnel 84 (best seen in Fig 6,15) disposed at a distal end thereof (as seen in Fig 6,15), the funnel tapering in a proximal direction such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel (as seen in Fig 15), and a proximal gate 82 having a closed configuration (seen in Fig 6) wherein the needle proximal end feature cannot pass through the proximal gate (Col 4, Lines 29-30), and an open configuration (seen in Fig 8) wherein the needle proximal end feature can pass through the proximal gate (Col 5, Lines 3-5). Elliott teaches that the funnel acts as an entryway for the needle into the plunger (Col 4, Lines 29-33) and the proximal gate acts as a seal to close the cylindrical injection body for storage prior to usage (Col 4, Lines 29-30 and 56-59). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz to include the stopper with a funnel and a proximal gate, as taught by Elliott, for the purpose providing an entryway for the needle into the plunger (Col 4, Lines 29-33) and providing a seal to close the cylindrical injection body for storage prior to usage (Col 4, Lines 29-30 and 56-59), respectively.
Re claim 19, Diaz discloses that the system has a transport configuration (seen in Fig 54K; Para 125, “Referring to Figure 54K, an injection assembly is in a stable configuration wherein it may be shipped or brought to an injection patient care scenario”) wherein the needle proximal end feature is disposed in the distal medicine chamber (as seen in Fig 54K), and wherein advancing the plunger member to pierce the proximal end of the needle member through the distal stopper member to allow the passage of the first medicine component from the proximal medicine chamber through the medicine passage and into the distal medicine chamber places the system in a transfer configuration (as seen in Fig 54M; Para 125, “Referring to Figure 54M, with further advancement, sufficient to stab the proximal end of the needle assembly across the distal stopper member (36), a fluid pathway is formed between the two previously isolated chambers of the syringe body (34), such that the diluent fluid (252) may flow into the proximal mixing port and exit the more distal mixing aperture, to reach the non-liquid medication component (254)”).
Re claim 20, Diaz discloses advancing the plunger member to position the proximal and distal stopper members in contact with each other (as seen in Fig 54N), thereby transferring the first medicine component from the proximal drug chamber to the distal drug chamber to mix the first medicine component with the second medicine component in the distal drug chamber, to place the system in a mixed configuration (Para 125, “Figure 54N illustrates that with further insertion until the stopper members (36,32) are immediately adjacent each other, the diluent (252) and previously non-liquid component (254) become mixed to form a medication solution (272)”).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz et al. (WO 2015/164839)/Elliott (US Pat 3,980,083) in view of Christakis (US Pat 3,200,813).
Re claim 5-7, Diaz/Elliott disclose all the claimed features except that the proximal opening of the needle is one of a plurality of proximal openings, wherein at least some of the plurality of proximal openings are disposed in the proximal drug chamber when the system is in the transfer configuration, and wherein at least some of the plurality of proximal openings are configured to be occluded by the proximal stopper member when the system is in the mixed configuration (as required by claim 5), wherein the proximal stopper member comprises a plug configured to occlude at least some of the plurality of proximal openings when the system is in the mixed configuration (as required by claim 6), and wherein a length of the plug is greater than a distance between a proximal most opening of the plurality of proximal openings and a distal most opening of the plurality of proximal openings (as required by claim 7). Christakis, however, teaches a system (Fig 1-4) comprising a cylindrical injection body 12 (Fig 2), a stopper member 24 (Fig 2) within the cylindrical injection body (as seen in Fig 2), and a needle 11 (Fig 2) located at a distal end of the cylindrical injection body (as seen in Fig 2), wherein the stopper member is in the form of a plug (as seen in Fig 2) and is directly attached to a distal end of a plunger member 14 (Fig 2) having an interior 16 (Fig 2) (like proximal stopper member 32 of Diaz and plunger member 44 of Diaz), wherein the needle comprises a plurality of proximal openings 31,32 (Fig 2,5), wherein at least some of the plurality of proximal openings 31,32 are disposed in a drug chamber formed by the distal surface of the stopper member (like the chamber holding drug component 252 of Diaz) when the proximal end of the needle is disposed in the drug chamber (as seen in Fig 2) (like in the transfer configuration Diaz), wherein the plug is configured to occlude at least some of the plurality of proximal openings (opening 32) when the stopper member is in contact with the proximal-facing surface of the distal wall 17 (as seen in Fig 4) (like when the proximal stopper member 32 of Diaz is in contact with the proximal-facing surface of the distal stopper member 36 of Diaz in the mixed configuration of Diaz), and wherein a length of the plug is greater than a distance between a proximal most opening of the plurality of openings (opening 31) and a distal most opening of the plurality of proximal openings (opening 32) (wherein the distance is measured from the proximal end of the distal most opening 32 to the distal end of the proximal most opening 31; as seen in Fig 4; Col 4, Lines 22-28) for the purpose of allowing fluid to be injected and fluid to be aspirated into the plunger member for sampling (Col 4, Lines 42-64). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz/Elliott to include the needle with a second proximal opening and to include the proximal stopper member as a plug that has a length to occlude at least some of the plurality of proximal openings when the system is in the mixed configuration, as taught by Christakis, for the purpose of providing a configuration that allows the system to be used for both injection and aspiration of a sample (Col 4, Lines 42-64).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Diaz et al. (WO 2015/164839)/Elliott (US Pat 3,980,083) in view of Rice et al. (US Pat 6,673,035).
Re claim 8, Diaz/Elliott disclose all the claimed features except that the cylindrical injection body comprises a position indicator configured to be adjacent with a distal end of the distal stopper member when the system is in the mixed configuration. Rice, however, teaches a system 200 (Fig 31) comprising a cylindrical injection body 24 (Fig 31), a proximal stopper member 28 (Fig 31), a distal stopper member 208 (Fig 31), a proximal drug chamber 206 (Fig 31), and a distal drug chamber 204 (Fig 31), wherein the cylindrical injection body comprises a position indicator 54 (seen in Fig 31, but not labeled; labeled in Fig 2) configured to be adjacent with a distal end of the distal stopper member when the system has mixed the contents of the proximal and distal drug chambers (as seen in Fig 32; Col 9, Lines 3-6) for the purpose of providing a visual assurance that the contents have been mixed (Col 5, Lines 35-38). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz/Elliott to include a position indicator, as taught by Rice, for the purpose of providing a visual assurance that the contents have been mixed (Col 5, Lines 35-38).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Diaz et al. (WO 2015/164839)/Elliott (US Pat 3,980,083) in view of Vacca (US Pat 5,380,295).
Re claim 9, Diaz/Elliott discloses all the claimed features except that the plunger member comprises a retention clip configured to be selectively coupled to the cylindrical injection body when the system is in the mixed configuration to prevent proximal movement of the plunger member relative to the cylindrical injection body. Vacca, however, teaches a system (Fig 8) comprising a cylindrical injection body 122 (Fig 8) and a plunger member 132 (Fig 8) comprising a retention clip 158+160+160 (Fig 8; Col 6, Lines 39-42) configured to be selectively coupled to the cylindrical injection body when the plunger member has been distally displaced the desired amount to prevent proximal movement of the plunger member relative to the cylindrical injection body (Col 6, Lines 51-55) for the purpose of maintaining sterility of the drug within the injection body (Col 2, Lines 3-11; Col 6, Line 64 - Col 7, Line 2). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz/Elliott to include a retention clip that proximal movement of the plunger member when the system is in the mixed configuration, as taught by Vacca, for the purpose of maintaining sterility of the mixture within the cylindrical injection body (Col 2, Lines 3-11; Col 6, Line 64 – Col 7, Line 2).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Diaz et al. (WO 2015/164839)/Elliott (US Pat 3,980,083)/Vacca (US Pat 5,380,295) in view of Mirzazadeh et al. (PG PUB 2016/0166772).
Re claim 10, Diaz/Elliott as modified by Vacca in the rejection of claim 9 discloses all the claimed features except explicitly disclosing that the retention clip of Vacca is configured to generate an audible signal when the retention clip is selectively coupled to the cylindrical injection body. Mirzazadeh, however, teaches a system (Fig 6,7) comprising a cylindrical injection body 11 (Fig 7) and a plunger member 10 (Fig 7) comprising a retention clip 32 (Fig 7; “flexible fingers”, Para 100; comparable to fingers 160 of Vacca) configured to generate an audible signal when the retention clip is selectively coupled to the cylindrical injection body (Para 38) for the purpose of conveying that the plunger has been displaced the desired amount without looking at it (Para 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz/Elliott/Vacca to include the retention clip such that it provides an audible signal, as taught by Mirzazadeh, for the purpose of conveying that the plunger has been displaced the desired amount without having to look at it (Para 7).
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz et al. (WO 2015/164839)/Elliott (US Pat 3,980,083) in view of Pierick (US Pat 3,405,712).
Re claim 12, Diaz/Elliott disclose all the claimed features except explicitly disclosing that the distal drug chamber contains a partial vacuum. Pierick, however, teaches a system (Fig 2) comprising a mixing/delivery needle 21 (Fig 2) and a stopper member 44 (Fig 2) separating a proximal drug chamber 41 (Fig 2) containing a first drug component 42 (Fig 2) to be mixed (as seen in Fig 2) and a distal drug chamber 24 (Fig 2) containing a second drug component 25 (Fig 2) to be mixed (as seen in Fig 2), wherein the distal drug chamber contains a partial vacuum (Col 4, Lines 42-46) for the purpose of causing the first drug component to be automatically sucked into the distal drug chamber when the stopper member is pierced by the mixing/delivery needle (Col 4, Lines 42-46). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz/Elliott to include a partial vacuum in the distal drug chamber, as taught by Pierick, for the purpose of causing the first drug component to be automatically sucked into the distal drug chamber when the distal stopper member is pierced by the mixing/delivery needle (Col 4, Lines 42-46).
Re claim 13, Diaz as modified by Elliott in the rejection of claim 1 above discloses all the claimed features with Elliott teaching that the proximal gate comprises a pair of movable arms operatively coupled to a pair of spring elements, the pair of spring elements biasing the proximal gate in the closed configuration. In a second embodiment, however, Elliott teaches a stopper member (seen in Fig 12) having a proximal gate 130 (Fig 12) comprising a pair of moveable arms (as seen in Fig 13 and described in Col 6, Lines 65-67, the diaphragm is pre-slit into four separate arms), the proximal gate 130 operatively coupled to a pair of spring element (the hinges connecting each arm to the rest of the stopper member; labeled in Fig A below) that bias the proximal gate in the closed configuration (Col 15, Lines 32-34) for the purpose of use with a needle proximal end feature that is blunt enough to prevent cutting of the stopper member (Col 6, Line 65 – Col 7, Line 4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz to include the proximal gate as one with a pair of movable arms and a pair of spring elements, as taught by the second embodiment of Elliott, for the purpose of use with a needle proximal end feature that is blunt enough to prevent cutting of the stopper member (Col 6, Line 65 – Col 7, Line 4).
PNG
media_image1.png
559
718
media_image1.png
Greyscale
Re claim 14, Diaz as modified by Elliott in the rejection of claim 1 above discloses all the claimed features with Elliott teaching that the needle proximal end feature comprises a proximal shoulder 42 that cannot past through the proximal gate in the closed configuration (as seen in Fig 6), but can pass through the proximal gate in the open configuration (as seen in Fig 8) for the purpose of locking the needle to the stopper member after the proximal gate has been opened (Col 5, Lines 3-19). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz to include the needle proximal end with a proximal shoulder which cannot pass through the proximal gate in the closed configuration but can pass through the proximal gate in the open configuration, as taught by Elliott, for the purpose of locking the needle to the stopper member after the proximal gate has been opened (Col 5, Lines 3-19).
Re claim 15, Diaz/Elliott as modified by Pierick in the rejection of claim 14 above discloses all the claimed features with Pierick teaching that the needle comprises a distal shoulder 50 that cannot pass through the proximal gate in the closed configuration (as seen in Fig 6), but can pass through the proximal gate in the open configuration (as seen in Fig 8), and wherein the distal shoulder is distal of the proximal shoulder (as seen in Fig 8).
Re claim 16, Diaz as modified by Elliott in the rejection of claim 1 above discloses all the claimed features with Elliott teaching that the proximal gate comprises a pair of movable arms operatively coupled to a pair of self-energizing hinges. In a second embodiment, however, Elliott teaches a stopper member (seen in Fig 12) having a proximal gate 130 (Fig 12) comprising a pair of moveable arms (as seen in Fig 13 and described in Col 6, Lines 65-67, the diaphragm is pre-slit into four separate arms), the proximal gate 130 operatively coupled to a pair of self-energizing hinges (the hinges connecting each arm to the rest of the stopper member; labeled in Fig A above) for the purpose of use with a needle proximal end feature that is blunt enough to prevent cutting of the stopper member (Col 6, Line 65 – Col 7, Line 4). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Diaz to include the proximal gate as one with a pair of movable arms and a pair of self-energizing hinges, as taught by the second embodiment of Elliott, for the purpose of use with a needle proximal end feature that is blunt enough to prevent cutting of the stopper member (Col 6, Line 65 – Col 7, Line 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 The subject matter that was examined and indicated allowable required the plunger member to include “a needle retention feature disposed in the plunger interior, an energy-storage member disposed in the plunger interior, and an energy-storage member latching member disposed in the plunger interior” and the needle to be “at least partially retractable into the plunger interior upon insertion of the plunger member relative to the cylindrical injection body to transform the energy-storage member latching member from a latched state to an unlatched state”.
2 A copy of which was provided by the Applicant with the 11/18/2025 IDS.
Prosecution Insights