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 .
This action is in response to Applicant’s amendments filed 6/12/2026
Claims 1, 2, and 5-9 are amended.
Claims 1-11 are being examined in this Office Action.
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 2-8 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.
Claim 2 recites the limitation “the fixing element” in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the fixing element” to be the previously recited “metal fixing element” as seen in claim 1.
Claim 3 recites the limitation “the fixing element” in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the fixing element” to be the previously recited “metal fixing element” as seen in claim 1.
Claim 4 recites the limitation “the fixing element” in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the fixing element” to be the previously recited “metal fixing element” as seen in claim 1.
Claim 5 recites the limitation “the fixing element” in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the fixing element” to be the previously recited “metal fixing element” as seen in claim 1.
Claim 6 recites the limitation “the fixing element” in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the fixing element” to be the previously recited “metal fixing element” as seen in claim 1.
Claim 6 recites the limitation “a form-fitting connection” in line 3. It is unclear if this is referencing the previously recited form-fitting connection as is claimed in claim 1, or if this is a separate form-fitting connection. Examiner interprets “a form-fitting connection” to be the previously recited form-fitting connection of claim 1.
Claim 7 recites the limitation “the fixing element” in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the fixing element” to be the previously recited “metal fixing element” as seen in claim 1.
All remaining claims are rejected by virtue of their dependence on a rejected claim.
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.
Claim(s) 1-6, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bissel (GB 1333215 A) in view of Lee (US 6824170 B2).
Regarding Claim 1, Bissel discloses a device for needle-free injection of a fluid (Page 1 Lines 10-13), comprising:
a first injector (Fig. 1), comprising:
a front dispensing end (12); and
a piston-cylinder arrangement (Fig. 1) in which a spring-pretensioned piston rod (15, Fig. 1, Page 1 Lines 14-20) is guided by its front end (Fig. 1) in a cylinder (22) for receiving the fluid to be injected (Fluid within reservoir, Page 1 Lines 15-17), the cylinder opening into a nozzle (24a) at the front dispensing end via a first nonreturn valve (26, Page 2 Lines 57-59),
wherein the cylinder (22) is configured together with the first nonreturn valve (26) and the nozzle as a releasable cylinder section (Page 2 Lines 53-55) in which a piston rod guide (23, 23a, 23b) is arranged releasably at a rear end which faces facing away from the nozzle (Figs. 2-3),
wherein the piston rod guide comprises a plastic guide bushing (23, Page 2 Lines 37-40) that guides the piston rod (Fig. 1),
and a metal fixing element (nut 23b, all parts appear to be metal unless otherwise specified in the art, Page 2 Lines 114-116) connected to the plastic guide bushing (23, Fig. 1),
wherein, in an installed state (Examiner interprets an installed state to be when all components are assembled together, such as in Fig. 1), the metal fixing element is fixed in the cylinder section (22, Fig. 1), and
wherein the metal fixing element includes an engagement region for a tool, into which the tool can be inserted in order then to release the metal fixing element from the cylinder section via the tool (23b being a threaded nut, Fig. 1, a tool must be used to screw nut in order to fix nut to the cylinder).
Bissel does not expressly disclose wherein the connection between the plastic guide bushing and the metal fixing element is a form-fitting connection such that a collar of the metal fixing element interlocks with the plastic guide bushing.
Lee teaches wherein the connection between the plastic guide bushing (12b, Fig. 4a, Examiner interprets grooved fitting 12b is plastic, Col. 9 Lines 39-41) and the metal fixing element (16, Fig. 4A, Examiner interprets coupling body 16 is made of a titanium alloy, Col. 9 Lines 39-41) is a form-fitting connection such that a collar of the metal fixing element (56) interlocks with the plastic guide bushing (enlarged flange 56 of coupling body 16 interlocking with annular groove 14 of grooved fitting 12b in Fig. 4A).
Additionally, Lee discloses the mating between the threaded fitting 50 and coupling body 16 may take other suitable forms such as quick disconnects, bayonet type fittings, or another collar section with locking pin and locking ring (Col. 9 Lines 35-38).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify a device for needle-free injection of a fluid disclosed by Bissel wherein the connection between the plastic guide bushing and the metal fixing element is a form-fitting connection such that a collar of the metal fixing element interlocks with the plastic guide bushing as taught by Lee so that there may be a removable coupling feature to allow connection and disconnection between two components (Lee, Col 1 Line 66 through Col. 2 Line 9).
Regarding Claim 2, modified Bissel in view of Lee discloses the device of claim 1, wherein the fixing element (Bissel, 23b) is screwed into the cylinder section (Bissel, 22) in the installed state (Bissel, Fig. 1 showing all components assembled together) for fixing purposes (Bissel, Page 1 Lines 22-24) and the fixing element is unscrewed from the cylinder section via the tool in order to release the fixing element (Bissel, nut 23b shows a thread that interfaces with housing 22, examiner interprets that a tool must be used in order to release the nut 23b from the housing 22).
Regarding Claim 3, modified Bissel in view of Lee discloses the device of claim 2, wherein the engagement region of the fixing element is configured such that the piston rod extends through the engagement region without touching it (Bissel, Page 2 Lines 44-46).
Regarding Claim 4, modified Bissel in view of Lee discloses the device of claim 1, wherein the engagement region of the fixing element is configured such that the piston rod extends through the engagement region without touching it (Bissel, Page 2 Lines 44-46).
Regarding Claim 5, modified Bissel in view of Lee discloses the device of claim 1, wherein the connection between the plastic guide bushing (Bissel, 23) and the fixing element (Bissel, 23b) is separable without a tool (Bissel, sealing washer 23 does not demonstrate threads like nut 23b does, examiner interprets that these elements are able to be separated from each other without the need of a tool).
Regarding Claim 6, modified Bissel in view of Lee discloses the device of claim 1, wherein the guide bushing (Lee, 12b) comprises a passage hole (Lee, central bore 18 as seen in Fig. 3) for guiding the piston rod (Bissel, Fig. 1 demonstrates plunger 15 fitting through bushing 23), and wherein the connection between the plastic guide bushing and the fixing element is a form-fitting connection (Lee, enlarged flange 56 of coupling body 16 interlocking with annular groove 14 of grooved fitting 12b in Fig. 4A) in a direction parallel to a longitudinal direction of the passage hole (Lee, Fig. 4A).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Bissel wherein the connection between the plastic guide bushing and the fixing element is a form-fitting connection in a direction parallel to a longitudinal direction of the passage hole as taught by Lee so that there may be a removable coupling feature to allow connection and disconnection between two components (Lee, Col 1 Line 66 through Col. 2 Line 9).
Regarding Claim 10, modified Bissel in view of Lee discloses the device of claim 1, wherein the releasable cylinder section is fixed to a rear injector section of the first injector via a union nut (Bissel, Page 2 Lines 53-55, screw on ring 24 fixes to housing to a front section of the injector, Fig. 1).
Regarding Claim 11, modified Bissel in view of Lee discloses device of claim 1, wherein the first injector is a self-filling syringe (Bissel, Page 1 Lines 10-21).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bissel in view of Lee further in view of Altermann et al. (Pub. No. US 20210069417 A1, herein Altermann).
Regarding Claim 7, modified Bissel in view of Lee discloses the device of claim 1, wherein the plastic guide bushing (Lee, 12a) has a first annular groove (Lee, 14) on its outer side (Lee, Fig. 4A).
Modified Bissel in view of Lee does not expressly disclose the collar of the fixing element has a lateral opening, such that the plastic guide bushing can be pushed into the collar and out of the collar via the lateral opening in the collar, and with the collar engaging in the first annular groove in the pushed-in state.
Altermann teaches wherein the plastic guide bushing (28) has a first annular groove on its outer side (see annotated Fig. 5 below) and the collar of the fixing element has a lateral opening (“An external thread 27 is formed, and a guide bushing 28 arranged, at the proximal end 26 of the front assembly 13, and therefore the front assembly 13 can be screwed into a distal end 30 of the receiving block 10 (FIG. 4) since an internal thread 31 for the external thread 27 of the front assembly 13 is provided in the distal end 30.” – Paragraph [0067]), such that the plastic guide bushing can be pushed into the collar and out of the collar via the lateral opening in the collar (Figs. 4-5), and with the collar engaging in the first annular groove in the pushed-in state (annotated Fig. 5, first annular groove is engaged within the receiving block 10).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by modified Bissel in view of Lee wherein the plastic guide bushing has a first annular groove on its outer side and the collar of the fixing element has a lateral opening, such that the plastic guide bushing can be pushed into the collar and out of the collar via the lateral opening in the collar, and with the collar engaging in the first annular groove in the pushed-in state as taught by Altermann so that the assembly can be easily separated to allow for maintenance of the device (Altermann, Paragraph [0022]).
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Regarding Claim 8, modified Bissel in view of Lee discloses the device of claim 7, wherein the plastic guide bushing has a second annular groove on its outer side, in which a seal sits (Altermann, annotated Fig. 5, O-ring placed within second annular groove, Paragraph [0097]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by modified Bissel in view of Lee wherein the plastic guide bushing has a second annular groove on its outer side, in which a seal sits as taught by Altermann in order to ensure sealing in the installed state (Altermann, Paragraph [0097]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bissel in view of Lee further in view of Rippstein, Jr. et al. (US 6458105 B1, herein Rippstein, Jr.).
Regarding Claim 9, modified Bissel in view of Lee discloses the device of claim 1.
Modified Bissel in view of Lee does not expressly disclose wherein the plastic guide bushing has an annular groove on its inner side, in which a second seal is disposed.
Rippstein, Jr. teaches wherein the plastic guide bushing (16, Col. 5 Lines 21-25) has an annular groove (74, Col. 6 Line 53, Fig. 2) on its inner side, in which a second seal (49) is disposed.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by modified Bissel in view of Lee wherein the plastic guide bushing has an annular groove on its inner side, in which a second seal is disposed as taught by Rippstein, Jr. so that the piston may be sealed from an outer surface (Col. 6 Lines 32-34).
Response to Arguments
Applicant’s arguments filed 06/12/2026 have been fully considered.
In regards to Applicant’s argument that:
“Claim 1 was objected to for certain informalities noted in the Office Action. Claim 1 has been amended as suggested by the Examiner in the Office Action. Therefore, withdrawal of the objection is respectfully requested.”
This argument is persuasive and the claim objection for claim 1 is withdrawn.
In regards to Applicant’s argument that:
“Claims 1-11 were rejected under 35 U.S.C. §112(b) or 35 U.S.C. §112 (pre-AIA ), second paragraph, as being indefinite. Applicant presently amends claims 1, 2 and 7 to remedy the specific concerns indicated in the Office Action. Applicant, therefore, respectfully requests withdrawal of the §112(b) indefiniteness rejections.”
This argument is persuasive and the 35 U.S.C. §112(b) rejection for claims 1-11 have been withdrawn. However, upon further consideration, a new 35 U.S.C. §112(b) rejection is made for claims 2-8.
In regards to Applicant’s argument that:
“Claim 1 is presently amended to recite that the connection between the plastic guide bushing and the metal fixing element is a form-fitting connection such that a collar of the metal fixing element interlocks with the plastic guide bushing. This language is supported by at least FIGS. 15-18 and the text of paragraphs [0012], [0116] and [0117] in the published version of the present application (US 2023/0310748 Al).
This argument is persuasive and the 35 U.S.C. § 102 rejection for claim 1 has been withdraw. However, after further search and consideration, a new ground of rejection is made in view of Bissel and Lee.
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 Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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