DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-7 and 11-17 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Gasaway (US 3,688,765).
With regard to claim 1, Gasaway teaches a needle-free injection device comprising: a first handle positioned to pivot between an open position and a closed position (Fig. 2 81 open, Fig. 3 81 closed); a main spring (Fig. 2 member 39); a hammer engaged with the main spring (Fig. 2 at least 36, 37, and 38 engaged via intervening structures); and a return sleeve (Fig. 2 member 18) comprising a body having a cylindrical inner surface and an opening extending through the body from a first end of the body to a second end of the body opposite the first end, the opening being configured to receive at least a portion of the hammer, the return sleeve being engaged with the hammer when the first handle is in the open position (Fig. 2 37 is in contact with 18), the return sleeve being disengaged with the hammer when the first handle is in the closed position (Fig. 3 37 is disengaged from 18), wherein the return sleeve is configured to move axially toward a first end of the needle-free injection device as the first handle is moved from the open position to the closed position (see the transition of 18 From Fig. 2 to Fig. 3), the movement of the return sleeve toward the first end compresses the main spring, and the main spring is configured to apply a driving force to the hammer in an axial direction toward a second end of the needle-free injection device (see the transition from Fig. 2-3, movement of 18 causes 39 to be released such that it compresses to drive 36, 37, and 38 in conjunction with the gas).
With regard to claims 2 and 3, when in the open position clip 85 holds the device such that the hammer and sleeve are bound (connected), in the closed position 85 is taken as disengaged from the hammer.
With regard to claim 4, 39 is compressed in the transition from Fig. 2 to Fig. 3, the linkage is taken as 85.
With regard to claim 5, 24 is taken as a latch and release sleeve as distinguished from the smaller diameter portion of 18 taken as the return sleeve (Fig. 3).
With regard to claim 6, see 83 (Fig. 2).
With regard to claim 7, see button 83, release 85 (Fig. 2, spring decompresses in Fig. 3).
With regard to claim 11, Gasaway teaches a method of operating a needle-free injection system comprising: providing a needle-free injection device comprising (Fig. 2); a first handle positioned to pivot between an open position and a closed position (Fig. 2 81 open, Fig. 3 81 closed); a main spring (Fig. 2 member 39); a hammer engaged with the main spring (Fig. 2 at least 36, 37, and 38 engaged via intervening structures); and a return sleeve (Fig. 2 member 18) comprising a body having a cylindrical inner surface and an opening extending through the body from a first end of the body to a second end of the body opposite the first end, the opening being configured to receive at least a portion of the hammer, the return sleeve being engaged with the hammer when the first handle is in the open position (Fig. 2 37 is in contact with 18), the return sleeve being disengaged with the hammer when the first handle is in the closed position (Fig. 3 37 is disengaged from 18), wherein the return sleeve is configured to move axially toward a first end of the needle-free injection device as the first handle is moved from the open position to the closed position (see the transition of 18 From Fig. 2 to Fig. 3), the movement of the return sleeve toward the first end compresses the main spring, and the main spring is configured to apply a driving force to the hammer in an axial direction toward a second end of the needle-free injection device (see the transition from Fig. 2-3, movement of 18 causes 39 to be released such that it compresses to drive 36, 37, and 38, in conjunction with the gas); and pivoting the first handle from the open position to the closed position causing the return sleeve to become disengaged from the hammer (see the transition of 18 From Fig. 2 to Fig. 3).
With regard to claims 12 and 13, when in the open position clip 85 holds the device such that the hammer and sleeve are bound (connected), in the closed position 85 is taken as disengaged from the hammer.
With regard to claim 14, 39 is compressed in the transition from Fig. 2 to Fig. 3, the linkage is taken as 85.
With regard to claim 15, 24 is taken as a latch and release sleeve as distinguished from the smaller diameter portion of 18 taken as the return sleeve (Fig. 3).
With regard to claim 16, see 83 (Fig. 2).
With regard to claim 17, see button 83, release 85 (Fig. 2, spring decompresses in Fig. 3).
With regard to claim
With regard to claim 21, Gasaway teaches a needle-free injection device comprising: a hammer (Fig. 2 at least 36, 37, and 38) configured to contact a plunger (Fig. 2 member 74) of a needle-free syringe; a main spring engaged with the hammer, the main spring configured to apply a driving force to the hammer (Fig. 2 member 39); and a return sleeve comprising a body surrounding at least a portion of the hammer (Fig. 2 member 18), the return sleeve being engaged with the hammer when the return sleeve is in a first position (Fig. 2 37 is in contact with 18), the return sleeve being disengaged with the hammer when the return sleeve is in a second position (Fig. 3 37 is disengaged from 18), wherein the return sleeve is configured to move axially toward a first end of the needle-free injection device in order to transition the return sleeve from the first position to the second position, and wherein the movement of the return sleeve toward the first end compresses the main spring (see the transition from Fig. 2-3, movement of 18 causes 39 to be released such that it compresses).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gasaway (US 3,688,765) as applied to claims 7 and 17 above, and further in view of Banker (US 3,292,622).
With regard to claims 8 and 18, Gasaway teaches a device and method substantially as claimed. Gasaway does not disclose ball bearings in a ball lock to release the hammer. However, Banker teaches a needle-free injection device in which the hammer is held in place by a ball bearing in a ball lock (ball 44, lock 47 and 66, Fig. 5, Col. 14 lines 55-60). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to use a ball which interacts with a lock in Gasaway as Banker teaches this to be an art effective retention mechanism which would yield the same predictable result. As combined, this would be incorporated into Gasaway where 85 is engaged. A ball and groove would be placed in the area of 24 to interact with a lock mechanism at the end of 85.
Allowable Subject Matter
Claims 9, 10, 19, and 20 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.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Spring 39 compresses, and moves the hammer in conjunction with the gas. There is nothing in the claim language that prevents additional driving means. If Applicant would like to conduct an interview, they are invited to contact the Examiner before filing a response. The Examiner notes allowable subject matter has been indicated if Applicant would like to advance prosecution.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 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.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783