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 on 18 August 2025.
Claims 9-11 are withdrawn.
Claim 4 and 14 are canceled.
Claims 1-3, 5-8, 12, and 13 are presently pending in this application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "452" and "454" have both been used to designate “more than one needle”. 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The disclosure states that membrane 704 is impermeable and adhesively attached to the housing 2 to seal at least one opening in the device, but does not disclose that the membrane is elastic and integrated into a semi-rigid structure. A separate structure, the septum 604, is elastic, impermeable, and integrated into a semi-rigid structure but is not adhesively attached to the housing 2.
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.
Claim 3, 8, and 12 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 3 recites the limitation “the energy storage devices” in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the energy storage devices are springs” as –the mechanical energy storage arrangement is a spring--.
Claim 8 recites the limitation “(…) integrated in a (…)”. It is not clear from this term whether the elastic membrane is integral or connected, but separate, to the semi-rigid structure.
For the purposes of examination, examiner will examine the previous claim 8 as filed 16 August 2023.
Claim 12 recites the limitation “the interior channel of the needle” in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the interior channel” as –an interior channel--.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Margairaz et al. (US Patent Publication No. 20180133395 A1), hereinafter Margairaz.
Margairaz teaches a fluid dispensing device (Margairaz: Fig. 11A, fluid dispensing device 310) adapted for intramuscular and/or subcutaneous injection into a living organism (subcutaneous insertion; para. 0106), the device (Fig. 11A, fluid dispensing device 310) having a single push button (Fig. 11A, button 342) and a mechanical energy storage arrangement (Fig. 11A, comprising compression spring 338, receiver flange 352, and receiver 340) enclosed in a housing (Fig. 11A, housing 332), wherein, upon triggering the single push button (Fig. 11A, button 342), the mechanical energy storage arrangement (Fig. 11A, comprising compression spring 338, receiver flange 352, and receiver 340) is adapted to provide energy in at least two bursts (Fig. 11A-11B, first, expansion of spring 338 translates the needle 312, then, the receiver 340, via the action of the receiver flange 352, collapses; para. 0107), the first burst (spring 338 expands, translating the needle 312 towards skin surface 326; para. 0107) being that which is necessary to pierce a skin of the living organism (para. 0107) and insert at least one needle (Fig. Fig. 11, needle 312) in the injection site (para. 0107), the second burst (Fig. 11B, receiver flange 352 contacts surface 364 and forces receiver 340 to squeeze reservoir 322) being that which is necessary to press a fluid (Fig. 11B, receiver 340 presses reservoir 322 and squeezes fluid 362 out of reservoir 322; para. 0107) out of at least one reservoir (Fig. 11A-11B, reservoir 322) and into the living organism (para. 0107), and, optionally, to retract the at least one needle (Fig. 11A, needle 312) out of the skin (needle 312 is drawn out of organism 14 via receiver 340 being able to pass through collet 334 upon collapse; para. 0107), wherein further the at least one needle (Fig. 11A: needle 312) has first and second ends (Fig. 11A: needle 312 comprises first end 314 and second end 316) which are adapted to pierce respective surfaces (first end 314, when translated, travels parallel to the patient skin to pierce reservoir 322; para. 0106-0107) while translating together in a direction (para. 0106-0107) such that when used, the direction of movement of the first end (Fig. 11A: first end 314) of the at least one needle (Fig. 11A: needle 312) is parallel to the skin (first end 314, when translated, travels parallel to the patient skin to pierce reservoir 322; para. 0106-0107) and the direction of movement of the second end (Fig. 11A: second end 316) of the at least one needle (Fig. 11A: needle 312) is substantially non orthogonal to the skin (Fig. 11A, second end 316 travels at an angle a shown on the figure; para. 0106-0107).
Regarding claim 2, Margairaz teaches the fluid dispensing device above, wherein the first burst (spring 338 expands, translating the needle 312 towards skin surface 326; para. 0107) is provided by a first energy source (Fig. 11A, spring 338) and the second burst (Fig. 11B, receiver flange 352 contacts surface 364 and forces receiver 340 to squeeze reservoir 322) is provided by a second energy source (Fig. 11A-11B, receiver 340).
Regarding claim 3, Margairaz teaches the fluid dispensing device above, wherein the mechanical energy storage arrangement (Fig. 11A, comprising compression spring 338, receiver flange 352, and receiver 340) is a spring (Fig. 11A, compression spring 338).
Regarding claim 5, Margairaz teaches the fluid dispensing device above, wherein the at least one needle (Fig. 11A: needle 312) passes through a mandrel (Fig. 11A, guide 324) which diverts the direction of translation of the at least one needle (Fig. 11A: needle 312 is guided by guide 324 towards patient skin; para. 0106) from one orientation, typically parallel, with respect to the patient's skin to a non-orthogonal angle with respect to the patient's skin (Fig. 11A: needle 312 is guided by guide 324 from parallel to the skin to an angle a shown on the figure, which travels towards the patient skin; para. 0106).
Regarding claim 6, Margairaz discloses the fluid dispensing device above, wherein the mandrel (Fig. 11A, guide 324) is adapted to deform the needle (Fig. 11A: needle 312) as it passes therethrough (guide 324 is adapted to deform needle to prevent reuse; para. 0106 and 0195).
Regarding claim 7, Margairaz discloses the fluid dispensing device above, wherein the mandrel (Fig. 11A, guide 324) is adapted to deform the needle (Fig. 11A: needle 312) beyond the needle's elastic limit thereby preventing re-use of the device (Fig. 11A, device 310). Examiner interprets the needle 312 is deformed beyond its elastic limit (para. 0170 and 0195).
Regarding claim 8, Margairaz discloses the fluid dispensing device above, wherein at least one thin, impermeable membrane (Fig. 31B, pierceable film 3704) is adhesively attached to the housing (Fig. 31B, pierceable film 3704 may be combined with the embodiment of Fig. 11A, para. 0171) is adhesively attached to housing (Fig. 31B, pierceable film 3704 of the adhesive tape 3702 is adhesively attached to housing 3701; para. 0171) so as to cover and seal an at least one opening (para. 0176) in the device through (Fig. 11A, device 310) which the at least one needle (Fig. 11A: needle 312) pierces and extends upon actuation for injection (para. 0176).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Margairaz, in view of Poganski et al. (US Patent Publication No. 20220296821 A1), hereinafter Poganski.
Regarding claim 12, Margairaz teaches the fluid dispensing device above.
Margairaz does not expressly disclose at least a portion of the interior channel of the needle conducting the fluid has a diameter different from that of another portion of the interior channel of the needle.
Poganski teaches at least a portion (Poganski: distal end of needle 52; para. 0048) of an interior channel (Poganski: Fig. 4, needles 52 conduct fluid and, therefore, have an interior channel; para. 0048) of the needle (Fig. 4, needles 52) conducting the fluid (needles 52 conduct fluid; para. 0048) has a diameter different from that of another portion (proximal end of needles 52; para. 0048) of the interior channel of the needle (the distal end of the needles 52 can have a diameter that is different from the proximal end; para. 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the needle of Margairaz such that at least a portion of the interior channel of the needle conducting the fluid has a diameter different from that of another portion of the interior channel of the needle as taught by Poganski in order to allow the proximal end of the needle to resist bending or shearing when piercing a septum while providing desired fluid flow of medication from the delivery device to the distal end of the needle, which is sized to reduce discomfort to the patient (para. 0048).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Margairaz, in view of Streeter et al. (US Patent Publication No. 20210228806 A1), hereinafter Streeter.
Regarding claim 13, Margairaz discloses the fluid dispensing device above.
Margairaz does not expressly disclose at least two needles may be accommodated in parallel within one housing to be used simultaneously to conduct the fluid into the living organism, so as to allow a simultaneous injection of several smaller doses of fluid, and to generate less pain when administered in potential multiple various locations.
Streeter teaches at least two needles (Streeter: Fig. 16A-16E, delivery members 320) may be accommodated in parallel within one housing (Fig. 16A-16E, delivery members 320 are parallel within lumen 112) are used simultaneously to conduct the fluid into the living organism (Fig. 16B, delivery members 320 delivery simultaneously; para. 0166), so as to allow a simultaneous injection of several smaller doses of fluid (Fig. 16B, delivery members 320 delivery simultaneously; para. 0166), and to generate less pain when administered in potential multiple various locations (generation of multiple injection columns 704 via the delivery members 320 allow for delivery with minimal shear forces and mechanochemical damage to the tissue; para. 0182)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Margairaz to include at least two needles within one housing are used simultaneously to conduct the fluid into the living organism as taught by Streeter in order to allow for a plurality of fluid delivery channels, which would allow for injection of a plurality of fluids (Streeter: para. 0033) and to minimize shear force and mechanochemical damage to the tissue (Streeter: para. 0182).
Response to Arguments
Applicant’s arguments, see page 1, filed 18 August 2025, with respect to the objection to claim 7 has been fully considered and are persuasive. The objection of claim 7 has been withdrawn.
Applicant’s arguments, see page 1, filed 18 August 2025, with respect to the rejections of claims 1-8, 12, and 13 under 35 USC 112(b) have been fully considered and are persuasive. The rejections of claims 1-8, 12, and 13 have been withdrawn.
Applicant’s arguments, see page 2, filed 18 August 2025, with respect to the rejections of claims 1-3, 5-8, 12, and 13 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Margairaz (previously Phillipe) as cited above.
Regarding applicants’ arguments for claims 5-7, and the previously filed claim 8, applicant argues:
“While Phillipe et al. may disclose certain injection-related features, it does not disclose nor suggest the claimed mandrel configuration, deformation of the needle (including beyond the elastic limit), or the sealing membrane structure of Claim 8.”
Margairaz discloses the mandrel (Fig. 11A, guide 324) of claims 5-7, adapted to deform the needle (Fig. 11A: needle 312) beyond the needle's elastic limit thereby preventing re-use of the device (Fig. 11A, device 310). Examiner interprets the needle 312 is deformed beyond its elastic limit (needle is deformed, preventing re-use; para. 0170 and 0195). Margairaz also discloses at least one thin, impermeable membrane (Fig. 31B, pierceable film 3704) is adhesively attached to the housing (Fig. 31B, pierceable film 3704 may be combined with the embodiment of Fig. 11A, para. 0171).
Regarding claim 13, applicant argues:
“As aforementioned, Evelyn discloses perpendicular needle movement, lacks any teaching of a mobile part moving substantially parallel to the skin, and does not disclose the use of multiple needles within one housing, as implied by Claim 13.
Streeter does not resolve these deficiencies. Streeter lacks any mechanism that ensures full completion of the injection process without further user action after triggering; insertion and retraction are performed manually. There is no disclosure in Streeter regarding the action of storing the needle within the device prior to injection, no retraction of the needle into the device after injection, and no bent or U-shaped needle configuration.
Furthermore, Streeter does not disclose nor suggest a structure enabling simultaneous use of at least two needles within one housing to conduct fluid into multiple locations.
Accordingly, the combination of Evelyn and Streeter would not yield the claimed invention without substantial redesign beyond the teachings of the cited references.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a mechanism that “ensures full completion of the injection process without further user action after triggering, an “action of storing the needle within the device prior to injection”, a “retraction of the needle into the device after injection”, and a “bent or U-shaped needle configuration”) are not recited in the rejected claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 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
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783