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
Election/Restrictions
Applicant's election with traverse of Species 1 in the reply filed on 5/12/26 is acknowledged. The traversal is on the ground(s) that there is no serious burden to search and examine species 1-3. This is not found persuasive because each species would require different search strategies and apply different prior art as presented in the restriction. Claims 2, 8, and 12, and 14 are withdrawn. It is noted that claim 12 claims “moving the needle from the shielded state to the unshielded state”. The elected invention does not move the needle – it moves the needle shield. Therefore claim 12 is withdrawn. However, the claim will be examined assuming that the claim is presented in error, where the needle is not moved, but “has” a shielded state and an unshielded state. Claims 9 and 15 appear to read on the elected species.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the needle sleeve (claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “18” [24, 30-35], “74” [29]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “26” has been used to designate two different elements (see Fig 2A and 2B). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “??” in Fig 1 and “110” Fig 7. 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. 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.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. 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.
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 13 is 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. It is unclear how both the needle and the needle shield may be moved. Furthermore, “the second position” and “the first position” lack antecedent basis.
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.
Claim(s) 1, 3-4, 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0110050 (Boyd).
Regarding claim 1, 3-4, 6, Boyd teaches an injection system (Fig 4-5) comprising: a housing having a first end and a second end opposite the first end (housing 16 with first end on the left, second end on the right), the housing defining an interior space (inside 16); a needle having an unshielded state (Fig 5) and a shielded state (para 70 - “the guard 22 will completely cover the injection needle 3”), the needle having a first end and a second end positioned opposite the first end, the second end having a piercing tip (needle 3 with first end on the left, second end on the right), at least a portion of the needle is positioned within the housing (Fig 4); and a syringe adapter connection interface configured to mate with a corresponding connection interface of a syringe adapter, the syringe adapter connection interface comprising a membrane and defining a passageway (syringe adapter connection interface including 10 and/or 14 with membrane 6a and/or 1 and passageway inside of 10, inside of which membrane 6a is located and/or the passageway inside 14 – para 67-68; “configured to mate …” is a statement of intended use and does not differentiate the structure from the prior art; it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" see MPEP 2114 [R-1]), a needle shield (22), wherein when the needle is in the unshielded state, the needle shield has a first position with the piercing tip of the needle positioned outside of the needle shield (Fig 5), wherein, when the needle is in the shielded state, the needle shield has a second position with the piercing tip of the needle positioned within the needle shield (para 70 – “the guard 22 will completely cover the injection needle 3”), and wherein the needle shield is moveable between the first position and the second position (para 67-70), the membrane seals the passageway within the syringe adapter connection interface (para 61, 63, 67), the needle and the passageway of the syringe adapter connection interface are in fluid communication (Fig 5, para 61).
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.
Claim(s) 1, 3-4, 6, 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0110050 (Boyd) in view of US 2018/0200148 (Sanders).
Regarding claim 1, 3-4, 6, Boyd teaches an injection system (Fig 4-5) comprising: a housing having a first end and a second end opposite the first end (housing 16 with first end on the left, second end on the right), the housing defining an interior space (inside 16); a needle having an unshielded state (Fig 5) and a shielded state (para 70 - “the guard 22 will completely cover the injection needle 3”), the needle having a first end and a second end positioned opposite the first end, the second end having a piercing tip (needle 3 with first end on the left, second end on the right), at least a portion of the needle is positioned within the housing (Fig 4); and a syringe adapter connection interface configured to mate with a corresponding connection interface of a syringe adapter, the syringe adapter connection interface comprising a membrane and defining a passageway (syringe adapter connection interface including 10 and/or 14 with membrane 6a and/or 1 and passageway inside of 10, inside of which membrane 6a is located and/or the passageway inside 14 – para 67-68; “configured to mate …” is a statement of intended use and does not differentiate the structure from the prior art; it has been held that “a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim" see MPEP 2114 [R-1]), a needle shield (22), wherein when the needle is in the unshielded state, the needle shield has a first position with the piercing tip of the needle positioned outside of the needle shield (Fig 5), wherein, when the needle is in the shielded state, the needle shield has a second position with the piercing tip of the needle positioned within the needle shield (para 70 – “the guard 22 will completely cover the injection needle 3”), and wherein the needle shield is moveable between the first position and the second position (para 67-70), the membrane seals the passageway within the syringe adapter connection interface (para 61, 63, 67), the needle and the passageway of the syringe adapter connection interface are in fluid communication (Fig 5, para 61).
Boyd teaches a syringe adapter connection interface as discussed above. However, Sanders also teaches a syringe adapter connection interface configured to mate with a corresponding connection interface of a syringe adapter, the syringe adapter connection interface comprising a membrane and defining a passageway (Fig 5-6; syringe adapter connection interface 96, membrane 94, passageway through the center – para 73). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a syringe adapter connection interface configured to mate with a corresponding connection interface of a syringe adapter, the syringe adapter connection interface comprising a membrane and defining a passageway in order to provide a substantially leak free connection, as taught by Sanders (para 73).
Regarding claims 9-10, Boyd in view of Sanders further teaches the syringe adapter connection interface comprises an interface body having a first end and a second end (Sanders Fig 6; interface body of 96 having a first end 104 and a second end 106 – para 73), and wherein the housing further comprises a housing luer connection, the housing luer connection configured to mate with an interface luer connection of the interface body (para 73; luer connection at 106 would mate with a corresponding luer connection on the housing when the combination is made), a syringe adapter configured to receive the syringe adapter connection interface (syringe adapter 12), wherein the syringe adapter receives the membrane of the syringe adapter connection interface (see para 73; membrane 94 engages membrane 34 inside the syringe adapter). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide an interface body having a first end and a second end, and wherein the housing further comprises a housing luer connection, the housing luer connection configured to mate with an interface luer connection of the interface body, a syringe adapter configured to receive the syringe adapter connection interface, wherein the syringe adapter receives the membrane of the syringe adapter connection interface in order to transfer fluid and provide a substantially leak-free connection, as taught by Sanders.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0110050 (Boyd) in view of US 2019/0134316 (Nishioka).
Regarding claim 5, Boyd fails to teach a saline solution positioned within a portion of the housing or within a portion of the syringe adapter connection interface. However, it was well known in the art that the drug may include saline, as taught by Nishioka (para 61). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a saline solution positioned within a portion of the housing or within a portion of the syringe adapter connection interface, as taught by Nishioka. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing a saline solution positioned within a portion of the housing or within a portion of the syringe adapter connection interface yields predictable results (mixing a drug, delivery of a drug).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0110050 (Boyd) in view of US 12453819 (Travanty).
Regarding claim 7, Boyd fails to teach a needle sleeve having a first position where the needle sleeve encloses the needle and a second position where the piercing tip of the needle is positioned outside of the needle sleeve. However, Travanty teaches a needle sleeve (Fig 30, col 22 ll. 37-col 23 l. 12; needle sleeve 404 enclosing the needle 406; second position when the needle sleeve is removed). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a needle sleeve having a first position where the needle sleeve encloses the needle and a second position where the piercing tip of the needle is positioned outside of the needle sleeve in order to protect the need during assembly or storage, as taught by Travanty.
Claim(s) 5, 11-13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0110050 (Boyd) in view of US 2018/0200148 (Sanders), and further in view of US 2019/0134316 (Nishioka).
Regarding claim 5, Boyd fails to teach a saline solution positioned within a portion of the housing or within a portion of the syringe adapter connection interface. However, it was well known in the art that the drug may include saline, as taught by Nishioka (para 61). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a saline solution positioned within a portion of the housing or within a portion of the syringe adapter connection interface, as taught by Nishioka. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing a saline solution positioned within a portion of the housing or within a portion of the syringe adapter connection interface yields predictable results (mixing a drug, delivery of a drug).
Regarding claim 11-13, Boyd in view of Sanders teaches a method of using the injection system of claim 1 (Boyd Fig 4-5, para 67-70) the method comprising: and engaging the syringe adapter connection interface with the housing (Sanders para 73; luer connection at 106 of the syringe adapter connection interface would mate with a corresponding luer connection on the housing when the combination is made), moving the needle from the shielded state to the unshielded state (as stated under the restriction above, this will be assumed to be in error for the needle having a shielded state and an unshielded state; Fig 5, para 70 - “the guard 22 will completely cover the injection needle 3”), moving the needle from the shielded state to the unshielded state comprises moving a needle shield from the second position to the first position when the needle is in the first position (shield 22; para 67-70), but fails to teach filling a portion of the housing or a portion of the syringe adapter connection interface with saline solution. However, Nishioka teaches that the injected drug may be a saline solution (para 61). It would have been obvious to one of ordinary skill in the art at the time of the invention to fill a portion of the housing or a portion of the syringe adapter connection interface with saline solution in order to deliver a drug comprising saline, as taught by Nishioka. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, filling a portion of the housing or a portion of the syringe adapter connection interface with saline solution yields predictable results (mixing a drug, delivery of a drug).
Regarding claim 15, Boyd in view of Sanders and Nishioka further teaches inserting the syringe adapter connection interface into the syringe adapter such that the membrane is received within the syringe adapter (see Sanders Fig 6, para 73; membrane 94 engages membrane 34 inside the syringe adapter). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide an interface body having a first end and a second end, and wherein the housing further comprises a housing luer connection, the housing luer connection configured to mate with an interface luer connection of the interface body, a syringe adapter configured to receive the syringe adapter connection interface, wherein the syringe adapter receives the membrane of the syringe adapter connection interface in order to transfer fluid and provide a substantially leak-free connection, as taught by Sanders.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0110050 (Boyd) in view of US 2018/0200148 (Sanders) and further in view of US 12453819 (Travanty).
Regarding claim 7, Boyd fails to teach a needle sleeve having a first position where the needle sleeve encloses the needle and a second position where the piercing tip of the needle is positioned outside of the needle sleeve. However, Travanty teaches a needle sleeve (Fig 30, col 22 ll. 37-col 23 l. 12; needle sleeve 404 enclosing the needle 406; second position when the needle sleeve is removed). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a needle sleeve having a first position where the needle sleeve encloses the needle and a second position where the piercing tip of the needle is positioned outside of the needle sleeve in order to protect the need during assembly or storage, as taught by Travanty.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2015/0374925 teaches an injection system with a needle shield (Fig 3; 150) and a needle sleeve (314). US 20070060840 teaches an injection system with a needle shield (19).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW NGUYEN whose telephone number is (571)270-5063. The examiner can normally be reached 8 am - 4 pm, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat (Pat) 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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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741
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