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 .
Priority
Election/Restrictions
Claims 3, 4, and 15-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, Species A, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/11/2026.
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.
Claim 5 is 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 5 recites the limitation "a migration pathway" in line 2. Said limitation is already recited in the claim from which this claim depends and it is unclear if applicant intends to introduce a second one or is referring to the first. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 6, 9, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jensen (US 2017/0043079 A1).
Re: Claim 1, Jensen discloses the claimed invention including a dispensing device, comprising:
an enclosure (12) delimiting a primary space (14) (Fig. 17a);
a flow regulator (21a) having a migration pathway (185’) in flow communication with the primary space (Fig. 17a); and
wherein the flow regulator is enabled to generate a pressure differential between the migration pathway and the primary space to at least partially evacuate the primary space through an exit pathway (Depicted in Fig. 5, para. 135, flow regulator generates pressure).
Re: Claim 6, Jensen discloses the claimed invention including a frangible seal (24’) is disposed between the primary space and the flow regulator.
Re: Claim 9, Jensen discloses the claimed invention including the flow regulator is disposed completely inside the enclosure (Fig. 1 depicts the flow regulator completely within the enclosure).
Re: Claim 10, Jensen discloses the claimed invention the flow regulator includes a flange (21C, 21B) that is attached to the enclosure such that the flow regulator is partially disposed in the enclosure (Depicted in Fig. 17a, the top of the flow regulator has a flange mating with the enclosure).
Claim(s) 2, 5, 7, 11, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2017/0043079 A1) as applied to claim 1 above, and further in view of Wieslander (US Patent No. 8,197,460).
Re: Claim 2, Jensen discloses the claimed invention including the flow regulator includes a priming pathway (19) (Fig. 17a) except for having a one-way valve. However, teaches a priming pathway having a one-way valve. However, Wieslander teaches that a variety of closures may be used on priming pathways including one-valves (4) (Col. 56-59, valves), wherein the migration pathway is bypassed by the priming pathway, and wherein the one- way valve is enabled to generate a pressure differential between the migration pathway (Fig. 17a, if priming pathway is closed due to valve/closure, pressure would increase on the migration pathway when the flow regulator generates pressure);
It would have been obvious to one having ordinary skill in the art at the time of effective filing date to include a one-way valve on the priming pathway, since such a modification would provide an automatic and effective way of sealing said path when not in use.
Re: Claim 5, Re: the flow regulator includes a migration pathway, a dispensing needle (21d), a hub (53), wherein the migration pathway is in flow communication with the primary space and wherein the needle is enabled to generate a pressure differential between the migration pathway and the primary space to at least partially evacuate the primary space (Depicted in Fig. 17a, needle moves to toward primary space for evacuation, para. 135, flow regulator generates pressure which includes the needle) except for a pressure sensitive bypass valve (78). However, Wieslander teaches that a variety of closures may be used on priming pathways including one-valves (4) (Col. 56-59, valves);
It would have been obvious to one having ordinary skill in the art at the time of effective filing date to include a one-way valve on the priming pathway, since such a modification would provide an automatic and effective way of sealing said path when not in use.
Re: Claim 7, Jensen discloses the claimed invention except for a secondary space having a seal between the primary space. However, Wieslander teaches an enclosure includes a secondary space (1) and a frangible seal (5) disposed between the secondary space and the primary space (2) (Fig. 1a).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to include a secondary seal as taught by Wieslander, since Wieslander states in col. 1, lines 33-40 that such a modification allows the device to hold a wider variety of fluids that require separate during storage thus improving the shelf life and efficacy of the product therein
Re: Claim 11, Jensen discloses the claimed invention including a dispensing device, comprising:
an enclosure (12’) delimiting a primary space (14) and a secondary space (12a) (Figs. 17a);
a flow regulator (21’) having a migration pathway (18’) in flow communication with the primary space (Figs. 4-5);
a first frangible seal (24’) disposed between the primary space and the flow regulator (Figs. 4-5) except for a secondary space having a seal between the primary space. However, Wieslander teaches an enclosure includes a secondary space (1) and a frangible seal (5) disposed between the secondary space and the primary space (2) (Fig. 1a).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to include a secondary seal as taught by Wieslander, since Wieslander states in col. 1, lines 33-40 that such a modification allows the device to hold a wider variety of fluids that require separate during storage thus improving the shelf life and efficacy of the product therein
wherein the flow regulator includes a priming pathway (19) (Fig. 17a) except for having a one-way valve. However, teaches a priming pathway having a one-way valve. However, Wieslander teaches that a variety of closures may be used on priming pathways including one-valves (4) (Col. 56-59, valves)
It would have been obvious to one having ordinary skill in the art at the time of effective filing date to include a one-way valve on the priming pathway, since such a modification would provide an automatic and effective way of sealing said path when not in use;
wherein the migration pathway is bypassed by the priming pathway, and wherein the one- way valve is enabled to generate a pressure differential between the migration pathway (Fig. 17a, if priming pathway is closed due to valve/closure, pressure would increase on the migration pathway when the flow regulator generates pressure); and
the primary space to at least partially evacuate the primary space through an exit pathway (28) (Fig. 17a).
Re: Claim 13, Jensen discloses the claimed invention including the flow regulator is disposed completely inside the enclosure (Fig. 1 depicts the flow regulator completely within the enclosure).
Re: Claim 14, Jensen discloses the claimed invention the flow regulator includes a flange (21C, 21B) that is attached to the enclosure such that the flow regulator is partially disposed in the enclosure (Depicted in Fig. 17a, the top of the flow regulator has a flange mating with the enclosure).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2017/0043079 A1) as applied to claim 1 above, and further in view of Becker (US Patent No. 5,577,369).
Re: Claim 8, Jensen discloses the claimed invention except for an injection port. However, Becker the enclosure includes an injection port (34) in flow communication with the primary space (14) (Fig. 1, Col. 4, lines 24-26, injection port)).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to include an injection port as taught by Becker, since Becker states col. 4, lines 25-27 that such a modification allows the user to refill the primary space thus the device may be reused again without waste.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 2017/0043079 A1) and Wieslander (US Patent No. 8,197,460) as applied to claim 11 above, and further in view of Becker (US Patent No. 5,577,369).
Re: Claim 12, Jensen discloses the claimed invention except for an injection port. However, Becker the enclosure includes an injection port (34) in flow communication with the primary space (14) (Fig. 1, Col. 4, lines 24-26, injection port)).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to include an injection port as taught by Becker, since Becker states col. 4, lines 25-27 that such a modification allows the user to refill the primary space thus the device may be reused again without waste.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. References cited on PTO-892 provide additional examples of enclosures with spaces and flow regulators.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES P. CHEYNEY whose telephone number is (571)272-9971. The examiner can normally be reached Monday - Friday, 8:00 am - 4:30 pm.
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/CHARLES P. CHEYNEY/Primary Examiner, Art Unit 3754
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