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 .
Election/Restrictions
Applicant’s election without traverse of claims 22-41 in the reply filed on 7/8/2026 is acknowledged.
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 22, 23, 29-31, 35-37, 39 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen (US 6,605,067 B1).
Regarding claim 22, Larsen discloses a compact auto-injector (column 4, lines 62-65, “injection syringe” connected with needle hub shown in figures 1, 5, 6 and 7) for administering a dose of epinephrine to a user, the auto-injector comprising:
a housing (entire housing of “injection syringe” and needle hub in column 4, lines 62-65);
a medicament dispensing system (system that expels dose including “ampoule” in column 4, lines 62-65 and needle 2, 3, 26, the system could include a plunger/piston along with any other associated features that operate the plunger/piston which has to be disposed in the housing to operate) disposed within the housing and comprising a medicament reservoir (column 4, lines 62-65, “an ampoule”) configured to hold a medicament comprising epinephrine (epinephrine could be placed inside “an ampoule”);
a needle extension system (mechanism shown in figures 1, 6 and 7) configured to fluidically connect to the medicament reservoir,
the needle extension system (mechanism shown in figures 1, 6 and 7) comprising an injection needle 3, 24 comprising a proximal section (section of element 3 connected to element 2 and being bent by element 10, section of element 24 connected to element 22 and being bent in figure 7) and a distal tip (tip of elements 3 and 24 that gets inserted into the patient),
a needle guide (see “G” in figures 1 and 7 below) configured for the injection needle 3, 24 to move therethrough, and
a needle barrel 14, 10 (combined structure formed by elements 10 and 14), 27 configured to rotate (see figure 6, to straighten the needle 24, element 24 has to rotate, column 5, lines 49-55) the proximal section of the injection needle thereby extending the distal tip of the injection needle through the needle guide.
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Regarding claim 23, Larsen does not explicitly recite wherein the housing further comprises a top portion and a bottom portion. However, one can construe that the housing (entire housing of “injection syringe” and needle hub in column 4, lines 62-65) would have a top portion (by considering portion of the housing located at top) and a bottom cover (by considering portion of the housing located at bottom). Thus, Larsen is inherently teaching the claimed features.
Regarding claim 29, Larsen teaches wherein the needle extension system (mechanism shown in figure 7) further comprises a NES biasing member 31, 14 coupled to the needle barrel 27, 14, 10 and configured to rotate the needle barrel to uncoil the proximal section of the injection needle (column 6, lines 42-48).
Regarding claim 30, Larsen teaches wherein the needle extension system further comprises a locking mechanism (column 6, lines 38-48, “pin”) configured to prevent an inadvertent movement of the NES biasing member 31.
Regarding claim 31, Larsen teaches wherein the medicament dispensing system further comprises a dispensing needle 2, 22 fluidically connected to the injection needle 3, 24.
Regarding claim 35, Larsen teaches wherein the extension of the distal tip of the injection needle 3 moves the distal tip of the injection needle 3 past a distal end (end of “G” in figure 1 above touching or closed by element 9) of the needle guide (see “G” in figure 1 above).
Regarding claim 36, Larsen teaches wherein extension of the distal tip of the injection needle 3 causes the distal tip of the injection needle to extend up to a subcutaneous or an intramuscular depth of the user (the limitation “extension of the distal tip of the injection needle causes the distal tip of the injection needle to extend up to a subcutaneous or an intramuscular depth of the user” is an intended use and the cited depth could be achieved by either placing the device at an angle such that the needle gets inserted at an angle into the patient such that the needle doesn’t go past subcutaneous or an intramuscular depth of the user or placing the device at a sufficient distance above the patient’s skin such that the needle extends up the claimed depth of the user).
Regarding claim 37, Larsen teaches wherein the distal tip of the injection needle 24 is configured to retract into the housing after administration of the medicament (column 6, lines 25-27, by pushing element 27 after delivery of the medicament, element 24 could be retracted into the housing).
Regarding claim 39, Larsen teaches wherein an axis of rotation of the needle barrel 10, 14 is substantially perpendicular (element 14 will push thereby rotating the structure of elements 10, 14 along an axis coming out of the figure 1 i.e. a radial direction and thus being perpendicular to longitudinal axis) to a longitudinal axis of the medicament reservoir (medicament reservoir is construed to be in line to attach with element 2 and thus sharing same longitudinal axis as longitudinal axis of the device shown in figure 1).
Regarding claim 41, Larsen teaches wherein at least a portion of the injection needle 3 is curved (element 3 is curved at element 14.
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 24, 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen (US 6,605,067 B1) in view of Sanofi (EP 2626095 A1, Inventor name is not designated so examiner is referring using applicant’s name).
Regarding claim 24, Larsen discloses the claimed invention substantially, as claimed, as set forth above in claim 22. Larsen is silent regarding wherein the top portion of the housing is configured to rotate relative to the bottom cover to move between a locked position and an unlocked position.
However, Sanofi teaches a design of an injector 5 (figure 1) comprising a housing (integrated structure formed by elements 10 and 15) comprising the top portion 15 and the bottom cover 10 wherein the top portion 15 of the housing is configured to rotate relative to the bottom cover (paragraph 0018, lines 3-8) between a locked position (position shown in figure 2 where the cartridge is inaccessible) and an unlocked position (position shown in figure 1 where the cartridge could be accessible for the replacement) for the purpose of designing a reusable auto-injector requiring replacement of only a cartridge after a medical use (paragraph 0001, lines 8-11).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the housing of Larsen to incorporate wherein the top portion of the housing is configured to rotate relative to the bottom cover to move between a locked position and an unlocked position as taught by Sanofi for the purpose of designing a reusable auto-injector requiring replacement of only a cartridge after a medical use (paragraph 0001, lines 8-11).
Regarding claim 27, Larsen discloses the claimed invention substantially, as claimed, as set forth above in claims 22 and 23. Larsen is silent regarding wherein the auto-injector further comprises a safety mechanism configured to engage with the bottom cover of the housing.
However, Sanofi teaches wherein the auto-injector further comprises a safety mechanism 20, 70 (paragraph 0026) configured to engage with the bottom cover of the housing for the purpose of adding a security of preventing additional dose after delivery of an initial dose (paragraph 0026).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the housing of Larsen to incorporate wherein the auto-injector further comprises a safety mechanism configured to engage with the bottom cover of the housing as taught by Sanofi for the purpose of adding a security of preventing additional dose after delivery of an initial dose (paragraph 0026).
Regarding claim 28, Larsen discloses the claimed invention substantially as claimed, as set forth above in claims 22 and 23. Larsen is silent regarding wherein the safety mechanism is configured to prevent rotation of the housing.
However, Sanofi teaches wherein the safety mechanism 20, 70 is configured to prevent rotation of the housing (element 20 will prevent the rotation along axis other than axis of the rotation) for the purpose of guiding the rotation of two housing parts along axis of rotation (paragraph 0018, lines 3-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the housing of Larsen to incorporate wherein the safety mechanism is configured to prevent rotation of the housing as taught by Sanofi for the purpose of guiding the rotation of two housing parts along axis of rotation (paragraph 0018, lines 3-8).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Larsen (US 6,605,067 B1) in view of Riker et al. (US 2,693,186).
Regarding claim 32, Larsen discloses the claimed invention substantially as claimed, as set forth above in claims 22 and 31. Larsen is silent regarding wherein the injection needle is fluidically connected to the dispensing needle by a flexible tube.
However, Riker teaches a design of an auto-injector (figure 2) wherein the injection needle 83 is fluidically connected to the dispensing needle 35 by a flexible tube 40 for the purpose of providing fluidic communication between the dispensing needle and the injection needle if the placement of the dispensing needle and the injection needle is far enough inside the housing to directly fluidically communicate with each other (figure 2, column 3, lines 49-51, column 2, lines 61-62).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection between the injection needle and the dispensing needle of Larsen to incorporate wherein the injection needle is fluidically connected to the dispensing needle by a flexible tube as taught by Riker for the purpose of providing fluidic communication between the dispensing needle and the injection needle if the placement of the dispensing needle and the injection needle is far enough inside the housing to directly fluidically communicate with each other (figure 2, column 3, lines 49-51, column 2, lines 61-62).
Allowable Subject Matter
Claims 25, 26, 33, 34, 38 and 40 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.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Larsen (US 6,605,067 B1) in view of Sanofi (EP 2626095 A1) is silent regarding wherein the auto-injector further comprises a biasing member configured to axially displace the top portion of the housing relative to the bottom cover when the housing is rotated from the locked position to the unlocked position, thereby increasing a height of the auto-injector in combination with other claimed limitations of claim 25.
Claim 26 being dependent on claim 25 is also indicated allowable.
The closest prior art of record, Larsen (US 6,605,067 B1), is silent regarding wherein the medicament dispensing system further comprises a MDS biasing member configured to move the dispensing needle in an axis different than the extension of the injection needle. Lavi et al. (US 2002/0007671 A1) discloses wherein the medicament dispensing system further comprises a MDS biasing member configured to move the dispensing needle in an axis different than the extension of the injection needle but one would not be motivated to combine the reference because Lavi teaches the use of biasing member to retract the needle. While Larsen teaches the retraction of the needle in figure 5 by pushing element 27 against the bias of the spring. Modifying Larsen in view of Lavi would either require the reverse operation of element 27 of Larsen which will break the principle of operating Larsen device or adding additional spring to perform the function of Lavi’s needle retraction, which will result in adding a complication without a strong motivation to perform such complex design. Thus, Larsen fails to disclose wherein the medicament dispensing system further comprises a MDS biasing member configured to move the dispensing needle in an axis different than the extension of the injection needle in combination with other claimed limitations of claim 33.
Claim 34 being dependent on claim 33 is also indicated allowable.
The closest prior art of record, Larsen (US 6,605,067 B1), is silent regarding wherein the housing increases in height to cover the distal tip of the injection needle after administration of the medicament in combination with other claimed limitations of claim 38.
The closest prior art of record, Larsen (US 6,605,067 B1), is silent regarding wherein the auto-injector has an aspect ratio of width to height in a range from 1 to 10 at administration of the medicament to the user in combination with other claimed limitations of claim 40.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang et al. (US 2005/0137525 A1): discloses the design of a needle that extends by rotating the proximal section of the needle via a needle barrel.
Balfour et al. (WO 00/56384): discloses a design of an adjustable and retractable needle assembly wherein rotating the needle barrel causes rotation of the needle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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