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 .
Status of Claims
This office action is responsive to the amendment filed 18 April 2023.
Claim 1 is canceled.
Claims 2-21 are added.
Claims 2-21 are presently pending in this application.
Election/Restriction
Claims 2, 11, and 17 are generic to the following disclosed patentably distinct species:
Species I – Fig. 1A-2B – drug cartridge is a tube with an O-ring
Species II – Fig. 3A-3C – drug cartridge is rectangular with channels
Species III – Fig. 4A-7B – drug cartridge is rectangular with a funnel
Species IV – Fig. 8A-8C – alternate ring arrangement
Species V – Fig. 9A-10B – funnel and cartridge plate are one piece
The species are independent or distinct because, as disclosed, the different species have mutually exclusive characteristics listed above for each identified species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The inventions have acquired a separate status in the art due to their recognized divergent subject matter
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Melissa Dobson on 10 September 2025 a provisional election was made without traverse to prosecute the invention of species V, claims 2-21. Affirmation of this election must be made by applicant in replying to this Office action.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following reference characters:
“102b” has been used to designate both a “second funnel body” and a “third funnel body” (para. 00101).
“104c” has been used to designate both a “fourth housing body” and a “stanchion ring” (para. 00101).
“140” has been used to designate “drug depots”, a “housing body”, and “drug pellets” (para. 0076 and 00104).
“210” has been used to designate both a “first ring member” and a “third ring member” (para. 00105).
“125” has been used to designate both “alignment ridges” and a “push rod” (para. 00127).
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.
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 2-10 are rejected under 35 U.S.C. 103 as being unpatentable over Simonton et al. (US Patent No. 8246571 B2), hereinafter Simonton, in view of Plaschkes (US Patent Publication No. 20150202367 A1), hereinafter Plaschkes, in further view of Grimm et al. (US Patent No. 4946035 A), hereinafter Grimm.
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Regarding claim 2, Simonton teaches a drug delivery device (Simonton: Fig. 2, delivery device) comprising: a housing (Fig. 5, housing 141) comprising: a lower body (Annotated Fig. 2, lower body A) comprising an annular step surface (Annotated Fig. 2, annular step surface B); piers (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16) comprising alignment grooves (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16); and stanchions (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16) comprising snap engagement apertures (Fig. 5, ledges 127 and 129); a drug cartridge (Fig. 5, drug cartridge 132) comprising: a depot channel (Fig. 5, channel 122) configured to store one or more drug depots (Fig. 5, depots 124, 126, and 128); and a body (Fig. 5, body of cartridge 132) comprising: prongs (Fig. 5, arms 120 and 121) configured to engage the snap engagement apertures (Fig. 5, ledges 127 and 129 are engaged with arms 120 and 121) of the housing (Fig. 5, housing 141).
Simonton does not expressly disclose the funnel body comprising alignment ridges configured to mate with the alignment grooves in the piers of the housing to align the drug cartridge with the housing.
Plaschkes teaches a drug cartridge (Fig. 38, injection module 140) comprising a body (Fig. 38, comprising mounting element 1900 and needle shield element 147) comprising alignment ridges (Fig. 40B, top recess wall surface 2174 and bottom recess wall surface 2076) configured to mate with alignment grooves (Fig. 1D, 4B, and 8A, top and bottom recess wall surfaces 2174 and 2076 mate with the areas under protrusion 360 and portion 563) in piers (Fig. 4B and 7A, walls 350 and 560) of the housing (Fig. 2, comprising upper housing assembly 104 and lower housing assembly 106) to align the drug cartridge (Fig. 38, injection module 140) with a housing (Fig. 2, comprising upper housing assembly 104 and lower housing assembly 106).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the housing and funnel body of Simonton such that the housing comprises piers comprising alignment grooves; the funnel body of the drug cartridge comprises an annular step surface alignment ridges configured to mate with the alignment grooves in the piers of the housing to align the drug cartridge with the housing as taught by Plaschkes in order to allow for the slidable insertion and mounting of the drug cartridge (Plaschkes: para. 0012). Examiner merely relies on Plaschkes to only teach the claimed structures cited above.
Simonton does not expressly disclose the funnel body of the drug cartridge comprising an annular step surface and a funnel bore in fluid communication with the depot channel.
Grimm teaches a funnel body (Grimm: Fig. 20, needle 20) of a drug cartridge (Fig. 4, cartridge 50) comprising an annular step surface (Fig. 20, needle 20 is stepped; col 3, ln 46-62) and a funnel bore (Fig. 20, needle bore 24) in fluid communication with the depot channel (Fig. 20, needle bore 24 contains pellets 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the funnel body of Simonton in view of Plaschkes such that the funnel body of the drug cartridge comprising an annular step surface and a funnel bore in fluid communication with the depot channel as taught by Grimm in order to allow retainment of the medicament pellets (Grimm: col 4, ln 4-16). Examiner merely relies on Grimm to only teach the claimed structures cited above.
Regarding claim 3, Simonton in view of Plaschkes and Grimm disclose the device above, wherein the housing comprises a viewing aperture configured to allow viewing of the one or more drug depots (Simonton: the housing can be transparent to see position of drug depot in channel of drug cartridge; col 25, ln 3-9).
Regarding claim 4, Simonton in view of Plaschkes and Grimm disclose the device above, wherein the drug cartridge is formed of a transparent material (Simonton: the housing can be transparent to see position of drug depot in channel of drug cartridge; col 25, ln 3-9).
Regarding claim 5, Simonton in view of Plaschkes and Grimm disclose the device above, wherein the drug cartridge is formed of a clear or translucent material (Simonton: the housing can be transparent to see position of drug depot in channel of drug cartridge; col 25, ln 3-9).
Regarding claim 6, Simonton in view of Plaschkes and Grimm disclose the device above.
Simonton in view of Plaschkes does not expressly disclose that the funnel bore has a funnel taper configured to guide a distal end of a push rod of a plunger upon insertion into the funnel bore.
Grimm teaches a funnel bore (Fig. 20, needle bore 24) that has a funnel taper (Fig. 20, rear end portion 23 is wider than needle bore 24) configured to guide a distal end of a push rod (Fig. 20, retention pin 30) of a plunger (Fig. 5, plunger 78 and impeller rod 80) upon insertion into the funnel bore (Fig. 20, rear end portion 23 is wider than needle bore 24 in order to slidably fit retention pin 30 into the needle bore 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the funnel bore of Simonton in view of Plaschkes such that the funnel bore has a funnel taper configured to guide a distal end of a push rod of a plunger upon insertion into the funnel bore as taught by Grimm in order to slidably fit the push rod and allow expulsion of the medicament pellets (Grimm: col 5, ln 48-62).
Regarding claim 7, Simonton in view of Plaschkes and Grimm disclose the device above, wherein the housing comprises indicia indicating a characteristic of the one or more drug depots (Simonton: housing may include dose indicator markings; col 17, ln 43-49).
Regarding claim 8, 15, and 20, Simonton in view of Plaschkes and Grimm disclose the device above, wherein the drug cartridge (Simonton: Fig. 5, cartridge 132) is preloaded with multiple drug depots (Fig. 5, drug depots 124, 126, and 128 are preloaded).
Regarding claim 9, 16, and 21, Simonton in view of Plaschkes and Grimm disclose the device above, wherein the pellets are rod shaped (Simonton: pellets can be rod shaped; col 19, ln 50-59).
Claims 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Simonton, in view of Plaschkes.
Regarding claim 11, Simonton teaches a drug delivery device (Simonton: Fig. 2, delivery device) comprising: a housing (Fig. 5, housing 141) comprising: a lower body (Annotated Fig. 2, lower body A) comprising an annular step surface (Annotated Fig. 2, annular step surface B); piers (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16) comprising alignment grooves (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16); and stanchions (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16) comprising snap engagement apertures (Fig. 5, ledges 127 and 129); a drug cartridge (Fig. 5, drug cartridge 132) comprising: and a body (Fig. 5, body of cartridge 132) comprising: prongs (Fig. 5, arms 120 and 121) configured to engage the snap engagement apertures (Fig. 5, ledges 127 and 129 are engaged with arms 120 and 121) of the housing (Fig. 5, housing 141).
Simonton does not expressly disclose the funnel body comprising alignment ridges configured to mate with the alignment grooves in the piers of the housing to align the drug cartridge with the housing.
Plaschkes teaches a drug cartridge (Fig. 38, injection module 140) comprising a body (Fig. 38, comprising mounting element 1900 and needle shield element 147) comprising alignment ridges (Fig. 40B, top recess wall surface 2174 and bottom recess wall surface 2076) configured to mate with alignment grooves (Fig. 1D, 4B, and 8A, top and bottom recess wall surfaces 2174 and 2076 mate with the areas under protrusion 360 and portion 563) in piers (Fig. 4B and 7A, walls 350 and 560) of the housing (Fig. 2, comprising upper housing assembly 104 and lower housing assembly 106) to align the drug cartridge (Fig. 38, injection module 140) with a housing (Fig. 2, comprising upper housing assembly 104 and lower housing assembly 106).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the housing and funnel body of Simonton such that the housing comprises piers comprising alignment grooves; the funnel body of the drug cartridge comprises an annular step surface alignment ridges configured to mate with the alignment grooves in the piers of the housing to align the drug cartridge with the housing as taught by Plaschkes in order to allow for the slidable insertion and mounting of the drug cartridge (Plaschkes: para. 0012). Examiner merely relies on Plaschkes to only teach the claimed structures cited above.
Regarding claim 12, Simonton in view of Plaschkes discloses the device above, wherein the housing comprises a viewing aperture configured to allow viewing of the one or more drug depots (Simonton: the housing can be transparent to see position of drug depot in channel of drug cartridge; col 25, ln 3-9).
Regarding claim 13, Simonton in view of Plaschkes discloses the device above, wherein the drug cartridge is formed of a transparent material (Simonton: the housing can be transparent to see position of drug depot in channel of drug cartridge; col 25, ln 3-9).
Regarding claim 14, Simonton in view of Plaschkes discloses the device above, wherein the drug cartridge is formed of a clear or translucent material (Simonton: the housing can be transparent to see position of drug depot in channel of drug cartridge; col 25, ln 3-9).
Regarding claim 15, Simonton in view of Plaschkes discloses the device above, wherein the drug cartridge (Simonton: Fig. 5, cartridge 132) is preloaded with multiple drug depots (Fig. 5, drug depots 124, 126, and 128 are preloaded).
Regarding claim 16, Simonton in view of Plaschkes discloses the device above, wherein the pellets are rod shaped (Simonton: pellets can be rod shaped; col 19, ln 50-59).
Regarding claim 17, Simonton teaches a drug delivery device (Simonton: Fig. 2, delivery device) comprising: a housing (Fig. 5, housing 141) comprising: a lower body (Annotated Fig. 2, lower body A) comprising an annular step surface (Annotated Fig. 2, annular step surface B); piers (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16) comprising alignment grooves (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16); and stanchions (mating members that are openings, recesses, and/or projections; col 11, ln 54 – col 12, ln 16) comprising snap engagement apertures (Fig. 5, ledges 127 and 129); a drug cartridge (Fig. 5, drug cartridge 132) comprising: a depot channel (Fig. 5, channel 122) configured to store one or more drug depots (Fig. 5, depots 124, 126, and 128); and a body (Fig. 5, body of cartridge 132) comprising: prongs (Fig. 5, arms 120 and 121) configured to engage the snap engagement apertures (Fig. 5, ledges 127 and 129 are engaged with arms 120 and 121) of the housing (Fig. 5, housing 141).
Simonton does not expressly disclose the funnel body comprising alignment ridges configured to mate with the alignment grooves in the piers of the housing to align the drug cartridge with the housing.
Plaschkes teaches a drug cartridge (Fig. 38, injection module 140) comprising a body (Fig. 38, comprising mounting element 1900 and needle shield element 147) comprising alignment ridges (Fig. 40B, top recess wall surface 2174 and bottom recess wall surface 2076) configured to mate with alignment grooves (Fig. 1D, 4B, and 8A, top and bottom recess wall surfaces 2174 and 2076 mate with the areas under protrusion 360 and portion 563) in piers (Fig. 4B and 7A, walls 350 and 560) of the housing (Fig. 2, comprising upper housing assembly 104 and lower housing assembly 106) to align the drug cartridge (Fig. 38, injection module 140) with a housing (Fig. 2, comprising upper housing assembly 104 and lower housing assembly 106).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the housing and funnel body of Simonton such that the housing comprises piers comprising alignment grooves; the funnel body of the drug cartridge comprises an annular step surface alignment ridges configured to mate with the alignment grooves in the piers of the housing to align the drug cartridge with the housing as taught by Plaschkes in order to allow for the slidable insertion and mounting of the drug cartridge (Plaschkes: para. 0012). Examiner merely relies on Plaschkes to only teach the claimed structures cited above.
Regarding claim 18, Simonton in view of Plaschkes discloses the device above, wherein the housing comprises a viewing aperture configured to allow viewing of the one or more drug depots (Simonton: the housing can be transparent to see position of drug depot in channel of drug cartridge; col 25, ln 3-9).
Regarding claim 19, Simonton in view of Plaschkes discloses the device above, wherein the drug cartridge is formed of a clear or translucent material (Simonton: the housing can be transparent to see position of drug depot in channel of drug cartridge; col 25, ln 3-9).
Regarding claim 20, Simonton in view of Plaschkes discloses the device above, wherein the drug cartridge (Simonton: Fig. 5, cartridge 132) is preloaded with multiple drug depots (Fig. 5, drug depots 124, 126, and 128 are preloaded).
Regarding claim 21, Simonton in view of Plaschkes discloses the device above, wherein the pellets are rod shaped (Simonton: pellets can be rod shaped; col 19, ln 50-59).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
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/LEI GONZALEZ/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783