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 .
Information Disclosure Statement
The information disclosure statement filed 10/13/2025 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 single reference noted has been lined through to indicate that is has not been considered. Specifically, CN-101829381-A has been provided along with a different document that appears to be a corresponding document written in English, but that document is not legible and therefore does not satisfy 37 CFR 1.98(a)(3)(i).
Status of the Claims
Claims 12-16 have been cancelled. Claims 1, 5, 7-8, and 10-11 are currently amended. Claims 1-11 are currently pending. Claims 1-11 are currently rejected.
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that Schneider (US 20140052075 A1) is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
In this case, Applicant argues that because Schneider is directed to a reusable drug delivery device and the Applicant’s claims are directed to a pre-filled injection device and concludes that due to this difference, Schneider is not combinable with Bengtsson-1 or Bengtsson-2 (both embodiments found in US 20180140776 A1).
Examiner notes that Schneider, like the device described in Applicant’s specification, is in the field of hand held, pen-like drug delivery devices. As such, Schneider falls within the field of the inventor’s endeavor, and both deal with maintaining the position of internal components of such a device. Regardless of one being single use and one being multiple use, these inventions are within the same field of endeavor and Shneider is reasonably pertinent to the problem of delivering a drug from a cartridge to a patient by using a driver including a threaded piston rod. Since Schneider is analogous to the Applicant’s disclosure, as described here, Examiner does not find this argument persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that the nut element of Schneider is not axially slidable relative to the housing structure and the resilient member is not capable of urging the nut element. However, Examiner relies on Schneider only for the teaching of a nut element engaging a housing structure via a resilient interface. The interface of Bengtsson-2 is modified by Schneider only to be resilient. This is a simple material modification which, as noted in the prior Office Action, would improve the lifespan of the interface of Bengtsson-2. As such, Examiner does not find this argument persuasive.
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 1-11 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.
Amended claim 1 still recites the limitation “the piston rod” on line 8. There is still insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted to be “the piston rod structure” as introduced on line 4 of claim 1. Examiner notes that claim 8 introduces “wherein the piston rod structure comprises a piston rod and a piston rod foot”. As currently written, claim 1 does not clearly communicate whether “the piston rod” is meant to introduce a piston rod or refer back to the “piston rod structure” introduced earlier in claim 1.
Claims 2-11 are also rejected for incorporating the subject matter of a claim rejected under 112(b), since dependent claims inherit the deficiencies of those claims on which they depend.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 8-11, is/are rejected under 35 U.S.C. 103 as being unpatentable over a first embodiment of Bengtsson et al (US 20180140776 A1; hereafter Bengtsson1) in view of a second embodiment of Bengtsson (hereafter Bengtsson2), and further in view of Schneider et al (US 20140052075 A1; hereafter Schneider).
Regarding claim 1, Bengtsson1 discloses a pre-filled injection device (pen device shown in fig. 1) for delivering a liquid drug ([0065] pen device expels a drug from a drug-filled cartridge 89 through the distal end of the distal housing component 2), comprising;
a housing structure (proximal housing component 1 and distal housing component 2; fig. 1;) extending along a longitudinal axis (X) defining a distal and a proximal direction ([0065] a proximal housing component 1 in which a drug expelling mechanism is arranged or integrated, and a distal housing component 2 forming a cartridge holder portion) and permanently embedding ([0067] The device is designed to irreplaceably accommodate a cartridge 89) a cartridge (cartridge 89, fig. 1) having a movable plunger (piston described in [0068] piston rod 7 transfers a force in the distal direction forcing the piston of the cartridge 89 to move distally for expelling a quantity equal to size of the set dose),
a piston rod structure (piston rod 7 and piston washer 9, fig. 1, [0072] piston rod 7 is in close proximity with the piston washer 9 which is located adjacent the piston of cartridge 89) for advancing the movable plunger (piston of cartridge 89 noted in [0068]) during dispensing ([0068] piston rod 7 transfers a force in the distal direction forcing the piston of the cartridge 89 to move distally for expelling a quantity equal to size of the set dose), the piston rod structure (7/9) having an outer thread (outer thread noted in [0068], fig. 1, [0068] piston rod 7 includes an outer thread adapted to engage the inner thread of the nut element 40) and a longitudinal track structure (longitudinal recessed track 6, fig. 1, [0068] piston rod 7 further includes a longitudinal recessed track 6),
a rotatable drive element (driver tube 85, fig. 1, [0068]) engaging the longitudinal track structure (6) ([0068] The piston rod 7 further includes a longitudinal recessed track 6, a pair of flattened surfaces or similar longitudinal extending geometry for cooperating with a mating geometry of a driver tube 85) of the piston rod structure (7/9) such that rotation of the drive element (85) is transferred to a rotation of the piston rod (7) (see 112b interpretation above) ([0068] mating geometry enables relative axial movement between the piston rod 7 and the driver tube 85 but prevents relative rotation)
a nut element (nut element 40, fig. 1, [0068]) having an inner thread (inner thread noted in [0068]) engaging the outer thread (outer thread noted in [0068]) of the piston rod structure (7/9) ([0068] piston rod 7 includes an outer thread adapted to engage the inner thread of the nut element 40), wherein the nut element (40) operates in two different states.
- a first state ([0072] piston rod 7 is provided in an already threadedly engaged state relative to nut element 40 as part of formation of distal subassembly),
- a second state wherein the nut element (40) is permanently secured to housing structure (1/2) (0072] the nut element 40 is secured relative to the distal housing component 2 at a particular predefined axial position by means of an axial snap fit),
and the nut element (40) in the second state is permanently secured ([0072] the nut element 40 is secured relative to the distal housing component 2 at a particular predefined axial position by means of an axial snap fit) to the housing structure (1/2), such that the piston rod structure (7/9) is moved helically relatively to the nut element (40) and the housing structure (1/2) when rotated ([0068] The driver tube 85 acts to rotate the piston rod 7 through the nut element 40, and the piston rod 7 moves distally).
Bengtsson1 is silent to the nut element is slidable in relation to the housing structure in the first state, the nut element abutting the movable plunger, and the nut element engaging the housing via a resilient interface.
Bengtsson2 teaches a first state (shown in fig. 4b) wherein the nut element (nut element 140, fig. 4b, [0078]) is arranged axially slidable in relation to the housing structure (distal housing component 102 and proximal housing component 101, fig. 4e, [0084]) ([0080] Subsequently, as shown in figs. 4d and 7, the piston rod assembly 107/140 has been moved axially relative to the distal housing component 102), and
- a second state wherein the piston rod structure (piston rod 107 and piston washer 109, fig. 5, [0076]) abuts the movable plunger (piston 199 of the held cartridge 189, see fig. 5, [0076] The axial indentations 102c and nut element 140 is allow elimination of a potential air gap between a piston rod 107 and a piston 199 of a held cartridge 189, [0078] fig. 4b shows a subsequent state after insertion of piston washer 199 in the distal housing component 102 so that the piston washer 109 is in abutting engagement with the piston 199 of the held cartridge 189) and the nut element is permanently secured to the housing structure (101/102) ([0082] when the piston rod assembly 107/140 assumes the desired axial position relative to the distal housing component 102, the nut element 140 is permanently secured to the distal housing component 102).
wherein, the nut element (140) in the first state engages the housing structure (101/102) via an interface (radial protrusions 140c, fig. 4a, [0076]) capable of (Claim language of “capable of” implies functional language and the prior art must only be capable of performing the recited function.) urging the nut element (140) axially in relation to the housing structure (101/102) ([0076] distal housing component 102 has respective indentation 102c, pairs of indentations 102c and protrusions 140c enable adjustment of the axial position of the nut element 140; see fig. 4c and 4d for axial movement; see fig. 4a for indentations 102c), such that the piston rod structure (107/109) abuts the movable plunger (199) ([0076] The axial indentations 102c and nut element 140 is allow elimination of a potential air gap between a piston rod 107 and a piston 199 of a held cartridge 189).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bengtsson1 to have the elements taught by Bengtsson2 since both embodiments deal with similar devices. One would have been motivated to make the modification because the sliding relation between the housing structure and the nut element interface taught by Bengtsson2 allows for adjustment of the relative axial position of the nut element and housing structure prior to permanently attaching the nut element and housing structure. Thus, as noted by Bengsston2 [0076] a potential air gap can be eliminated between the piston rod and piston of the cartridge, allowing for more immediate delivery of drug upon activation of the device.
Bengtsson1 and Bengtsson2 are silent to the nut element engaging the housing structure via a resilient interface.
Schneider, in the art of drug delivery devices, teaches wherein, the nut element (guide nut 4, fig. 4, [0089]) engages the housing structure via a resilient interface (resilient member 10, interaction member 14; fig. 2; [0089] The resilient member 10 and the interaction member 14 encompass a guide nut 4 when assembled within the housing 3 of the device 1).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the interface of Bengtsson2 to be resilient as taught by Schneider, since both deal with the spatial arrangement of a nut relative to a housing. One would have been motivated to make the modification because the interface being resilient would reduce the chances that the interface would snap during a series of moves between detents/positions which may otherwise stress a more brittle interface material.
Regarding claim 2, Bengtsson1 modified by Bengtsson2 and Schneider discloses the injection device according to claim 1, including wherein the nut element (40) is permanently secured to the housing structure (1/2) (([0072] the nut element 40 is secured relative to the distal housing component 2 at a particular predefined axial position by means of an axial snap fit).
Bengtsson1 is silent to the attachment method being welding.
Bengtsson2 further teaches wherein the nut element (140) is permanently secured ([0082] when the piston rod assembly 107/140 assumes the desired axial position relative to the distal housing component 102, the nut element 140 is permanently secured to the distal housing component 102) to the housing structure (101/102) by welding ([0082] the nut element 140 is permanently secured to the distal housing component 102 by joining using laser radiation, ultrasonic welding, or induction welding).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to utilize the welding methods of Bengtsson2 to attach the nut element and housing of Bengtsson1 modified by Bengtsson2 and Schneider since Bengtsson2 has a similar structure. One would have been motivated to make the modification because the welding methods taught by Bengtsson2 would ensure that the nut element could not be knocked or accidentally moved out of the correct axial position after assembly is completed.
Regarding claim 3, Bengtsson1 modified by Bengtsson2 and Schneider discloses the injection device according to claim 1, including wherein the resilient interface (Bengsston2: radial protrusions 140c, fig. 4a) comprises a number of flexible arms (Bengsston2 [0076] notes multiple radial protrusions 140c; protrusions are modified to be resilient as taught by Schneider, see claim 1 rejection).
Regarding claim 4, Bengtsson1 modified by Bengtsson2 and Schneider discloses the injection device according to claim 3, as described above, including wherein the flexible arms (Bengsston2: radial protrusions 140c, fig. 4a) have a radial resiliency (Examiner reiterates that the protrusions are modified to be resilient as taught by Schneider, see claim 1 rejection) and are operational between the nut element (140) and the housing structure (102) (see fig. 4; [0076] protrusions 140c engage with the distal housing component 102).
Regarding claim 8, Bengtsson1 modified by Bengtsson2 and Schneider discloses the injection device according to claim 1, as described above, including wherein the piston rod structure (piston rod 7 and piston washer 9, fig. 1, [0067] piston washer 9 may be located between the piston rod and the piston for transferring axial forces exerted by the piston rod to the piston; [0072] piston rod 7 is in close proximity with the piston washer 9 which is located adjacent the piston of cartridge 89) comprises a piston rod (piston rod 7) and a piston rod foot (piston washer 9).
Regarding claim 9, Bengtsson1 modified by Bengtsson2 and Schneider discloses the injection device according to claim 1, as described above, including wherein the housing structure (101/102, fig. 4e) has a passage (indentation 102a; [0082] As shown in FIGS. 4d and 7, when the piston rod assembly 107/140 assumes the desired axial position relative to the distal housing component 102, the nut element 140 is permanently secured to the distal housing component 102) for a laser beam ("L") ([0082] attachment may be achieved by means of an adhesive or joining using laser radiation; Examiner notes that indentation 102a allow for the nut 140 to engage the housing 102).
Regarding claim 10, Bengtsson1 modified by Bengtsson2 and Schneider discloses the injection device according to claim 1 (see 103 rejection of claim 1 above).
Bengtsson2 discloses a method for assembling an injection device, the method comprising the steps of:
threadedly engaging the nut element (nut element 140, fig. 4b) and piston rod structure (piston rod 107 and piston washer 109, fig. 4b, [0078]) by rotating the nut element (140) and the piston rod structure (107/109) relatively to each other ([0078] the piston rod 107 and the nut element 140 are brought in threaded engagement 107a/140a with each other to form a piston rod assembly),
translating the nut element (140) together with the piston rod structure (107/109) relatively to the housing structure (distal housing component 102 and proximal housing component 101, fig. 4e, [0084]) ([0081] piston rod assembly 107/140 is moved axially with respect to the distal housing component 102),
inserting at least the proximal part of the cartridge (cartridge 189, fig. 4a, [0077]) together with the plunger ([0078] piston 199 of the held cartridge 189, fig. 5) into the housing structure (101/102) ([0078] fig. 4b shows a state after insertion of both cartridge 189 and piston 199; see also fig. 5),
moving the cartridge (189) and therewith the plunger (199) proximally into a position wherein the plunger (199) inside the cartridge (189) abuts the piston rod structure (107/109) ([0078] fig. 4b shows the piston 199 in the distal housing component 102 in abutting engagement with piston washer 109), and
securing the nut element (140) to the housing structure (101/102) in this position ([0082] when the piston rod assembly 107/140 assumes the desired axial position relative to the distal housing component 102, the nut element 140 is permanently secured to the distal housing component 102).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the method of assembly taught by Bengtsson2 to assemble the device of Bengtsson1 modified by Bengtsson2 and Schneider because the form of the device is very similar to that of Bengtsson2. One would have been motivated to use the method of assembly taught by Bengtsson2 because the method accommodates the arms/protrusions 140c and allows them to be welded to the housing for a secure final construction.
Regarding claim 11, Bengtsson1 modified by Bengtsson2 and Schneider discloses the method for assembling an injection device according to claim 10, as described above, including wherein the nut element (Bengtsson1: 40, fig. 1 ; Bengtsson2: 140, fig. 4a) has at least one flexible arm (Bengtsson2: 140c, fig. 4a; protrusions are modified to be resilient as taught by Schneider, see claim 1 rejection), and wherein the at least one flexible arm (140c, fig. 4a) of the nut element (140, fig. 4a) is welded to the housing structure (101/102, fig. 4e) in the position wherein the plunger (199, fig. 5) inside the cartridge (189, fig. 4a, fig. 5) abuts the piston rod structure (107/109, fig. 4a) ([0080] piston rod assembly 107/140 is moved axially relative to the distal housing component 102 so abutment between the piston rod 107 and the piston washer 109 is obtained.).
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over a first Bengtsson1 modified by Bengtsson2 and Schneider, as applied to claim 1, and further in view of Atterbury et al (US 20040210199 A1; hereafter Atterbury).
Regarding claim 5, Bengtsson1 modified by Bengtsson2 and Schneider discloses the injection device according to claim 3, as described above, including wherein the flexible arms (Bengtsson2: 140c, fig. 4a; protrusions are modified to be resilient as taught by Schneider, see claim 1 rejection) are provided on the nut element (140, fig. 4a) and abut the housing structure (101/102) (see fig. 4c, [0076] protrusions 140c engage with the distal housing component 102).
Bengtsson1 and Bengtsson2 are silent to the flexible arms abutting an inner surface of the housing structure. Bengtsson2 does note that a series of micro detents may be arranged ([0086] In other embodiments, between distal housing component 102 and nut element 140 a series of micro detents may be arranged to provide relative axial variation to be performed in a series of predefined axial increments).
Atterbury, directed to a medication injector apparatus and drive assembly, teaches arms (keys 74, fig. 5, [0085]) provided on a nut element (floating nut 60, fig. 5, [0085]) and abutting an inner surface of a housing structure (housing body portion 64, fig. 3) ([0085] radially projecting keys 74 on nut body section 70 fit within axially aligned grooves or keyways 65 formed in housing body portion 64; fig. 3 shows that the keys 74 are within the housing keyways 65).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the housing of the device to include the keyways formed on the inner surface of housing body portion as taught by Atterbury since Atterbury is also dealing with a nut sliding within a housing as noted in Atterbury ([0085] keying allows the nut to travel in an axial direction therein while preventing rotational motion of the nut within the housing at any given axial position). One would have been motivated to make the modification because by locating the arms of the nut within the device, it is harder to tamper with the location of the nut and housing after construction is complete since the nut is more protected within the housing.
Regarding claim 6, Bengtsson1 modified by Bengtsson2, Schneider, and Atterbury, as applied to claim 5, disclose the injection device according to claim 5, wherein the inner surface abutting the flexible arms (Bengtsson2: 140c, fig. 4a; protrusions are modified to be resilient as taught by Schneider, see claim 1 rejection) is formed as grooves (Atterbury: grooves or keyways 65; fig. 3; [0085] radially projecting keys 74 on nut body section 70 fit within axially aligned grooves or keyways 65 formed in housing body portion 64).
Regarding claim 7, Bengtsson1 modified by Bengtsson2, Schneider, and Atterbury discloses the injection device according to claim 6, including wherein the grooves (Atterbury: grooves or keyways 65; fig. 3) have a sloped bottom angled in the distal direction (see fig. 3 which shows that the grooves 65 gradually widen/narrow along the proximal/distal axis).
Conclusion
THIS ACTION IS MADE FINAL. 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 ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 11/21/2025