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 .
Response to Amendment
This office action is responsive to the preliminary amendment filed on 11/13/2024. As directed by the amendment: claim 1 has been cancelled, claims 2-20 have been added.
Thus, claims 2-20 are pending in this application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference number 400 in figures 9A-C is not in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities:
Para 72, line 9, “incommunicated” should read “uncommunicated”.
Appropriate correction is required.
Claim Objections
Claims 1, 3, 6, 8 and 13-20 are objected to because of the following informalities:
Claim 1, line 17, “a plunger rod” should read “a first plunger rod”.
Claim 3, line 2, “the plunger rod” should read “the first plunger rod”.
Claim 6, line 2, “the plunger rod” should read “the first plunger rod”.
Claim 8, line 3 and 4, “ the first plunger” should read “the first plunger rod”.
Claim 13, line 2, “a stored energy source” should read “the stored energy source”.
Claim 14, line 1, “the first medicament” should read “the first medicament component”.
Claim 15, line 1, “the second medicament” should read “the second medicament component”.
Claims 16-20, line 1, “the drug mixing and drug delivery system” should read “the drug mixing system”.
Appropriate correction is required.
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 7-10, 12, 13 and 18-20 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 7 recites the limitation "the delivery assembly" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 8 and 13 are also rejected by virtue of dependency.
Claim 9 recites the limitation "the actuation device" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 is also rejected by virtue of dependency.
Claim 12 recites the limitation "the needle shield assembly" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the proximal end of the first container" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 19 and 20 are also rejected by virtue of dependency.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. US 12128221 B2 in view of Haber et al (US 5445614 A).
Regarding claim 2, claims 1 and 6 of US 12128221 B2 disclose the limitations of claim 2 but fail to teach a plunger rod associated with the first plunger.
Haber et al disclose a drug mixing system (S) comprising a first plunger (18) and a plunger rod (P1) associated with the first plunger (figs 2-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of US 12128221 B2 to a plunger rod associated with the first plunger. This would provide the benefit of a plunger rod that compresses the first plunger to be locked in place (col 3, lines 10-13).
Regarding claim 3, Haber et al in view of US 12128221 B2 disclose a drug mixing system (S) comprising a release slider (40) and a plunger rod (P1) wherein the release slider transfers laterally to engage the plunger rod (fig 2, col 3, lines 9-12).
Regarding claim 4, Haber et al in view of US 12128221 B2 disclose the drug mixing system of claim 3,
Haber et al further teach wherein the release slider (40) is received in a plunger rod detent (39).
Regarding claim 5, Haber et al in view of US 12128221 B2 disclose the drug mixing system of claim 3,
Haber et al further teach said system comprising a delivery collar (36), the delivery collar disposed laterally outward of the release slider (see figs 2-3).
Regarding claim 6, Haber et al in view of US 12128221 B2 disclose wherein the release slider (40) applies pressure on a side of the plunger rod (fig 3).
Claim 7 encompasses the scope of claim 1 of prior U.S. Patent No. US 12128221 B2.
Claim 8 encompasses the scope of claim 3 of prior U.S. Patent No. US 12128221 B2.
Claim 9 encompasses the scope of claim 4 of prior U.S. Patent No. US 12128221 B2.
Claim 10 encompasses the scope of claim 5 of prior U.S. Patent No. US 12128221 B2.
Claim 11 encompasses the scope of claim 2 of prior U.S. Patent No. US 12128221 B2.
Claim 12 encompasses the scope of claim 8 of prior U.S. Patent No. US 12128221 B2.
Claim 13 encompasses the scope of claim 7 of prior U.S. Patent No. US 12128221 B2.
Claim 14 encompasses the scope of claim 10 of prior U.S. Patent No. US 12128221 B2.
Claim 15 encompasses the scope of claim 11 of prior U.S. Patent No. US 12128221 B2.
Claim 16 encompasses the scope of claim 21 of prior U.S. Patent No. US 12128221 B2.
Claim 17 encompasses the scope of claim 9 of prior U.S. Patent No. US 12128221 B2.
Claim 18 encompasses the scope of claim 12 of prior U.S. Patent No. US 12128221 B2.
Claim 19 encompasses the scope of claim 13 of prior U.S. Patent No. US 12128221 B2.
Claim 20 encompasses the scope of claim 14 of prior U.S. Patent No. US 12128221 B2.
Claim Rejections - 35 USC § 102
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 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.
Claims 2, 6, 7, 9, 10, 13-15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sarnoff et al (US 4689042 A).
Regarding claim 2, Sarnoff et al disclose a drug mixing system (10) comprising: a housing (28) configured to hold a first container (76) and a second container (78), where in the first container (76) contains a first medicament component (104) and the second container (78) contains a second medicament component (108); a first seal (90); a second seal (100); a seal opening component (64/70) configured to open, remove or otherwise pierce the first seal and the second seal (col 7, lines 57-64); a fluidic channel (56) that allows for fluidic communication between the first and second containers once the seal opening component has caused each of the first and second seals to be altered from a sealed stated to an open state (col 8, lines 3-6); a first plunger (106) at least partially disposed within the first container and a second plunger (110/136) at least partially disposed within the second container (figs 1-2), wherein depressing the first plunger drives a portion of the first medicament from the first container through the fluidic channel into the second container to mix with the second medicament (col 8, lines 6-14), a plunger rod (116) associated with the first plunger (fig 2), a release slider (130) configured to engage the first plunger rod to lock the first plunger rod in place (col 6, lines 58-68), and wherein the second plunger (78) when depressed during a second transfer state causes a portion of the mixed medicament in the second container to transfer from the second container through the fluidic channel into the first container (col 8, lines 67-68 and col 9, lines 1-4, the fluid may cross passage 60 into the container 76, thus a portion of the mixed medicament is transferred back to said second container 76).
Regarding claim 6, Sarnoff et al disclose the drug mixing system of claim 2, wherein the release slider (130) applies pressure on a side of the plunger rod (col 5, lines 52-66).
Regarding claim 7, Sarnoff et al disclose the drug mixing system of claim 2, further comprising an actuation device (162) that includes a stored energy source (156), whereupon actuating the actuation device causes the stored energy source to release and cause the second plunger to depress and force the mixed medicament disposed in the second container to flow out of the delivery assembly (col 8, lines 50-68 and col 9, lines 1-20).
Regarding claim 9, Sarnoff et al disclose the drug mixing system of claim 2, further comprising a needle shield assembly (40) that is coupled to the actuation device (col 8, lines 43-52).
Regarding claim 10, Sarnoff et al disclose the drug mixing system of claim 9, wherein the needle shield assembly (40) functions as a bump trigger to actuate the actuation device (col 8, lines 43-52).
Regarding claim 13, Sarnoff et al disclose the drug mixing system of claim 7, wherein the actuation device (162) is configured to release a stored energy source (156) associated with the second plunger (136) and configured to drive the second plunger (col 8, lines 50-64).
Regarding claim 14, Sarnoff et al disclose the drug mixing system of claim 2, wherein the first medicament (104) is in a liquid form (col 5, line 1-2).
Regarding claim 15, Sarnoff et al disclose the drug mixing system of claim 2, wherein the second medicament (108) is in a liquid or dry form (col 5, line 7-10).
Regarding claim 17, Sarnoff et al disclose the drug mixing and drug delivery system of claim 2, wherein the first container (76) and the second container (78) are aligned side-by-side to each other with both distal ends pointing in the same direction (figs 1-2).
Regarding claim 18, Sarnoff et al disclose the drug mixing and delivery system of claim 2, further including a safety release (130) disposed about the proximal end of the first container (fig 1).
Regarding claim 19, Sarnoff et al disclose the drug mixing and delivery system of claim 18, further including a transfer spring (132) and a driver (116), wherein the driver is configured to engage with the first plunger (106, see fig 1).
Regarding claim 20, Sarnoff et al disclose the drug mixing and delivery system of claim 19, whereupon removal of the safety release causes the driver to depress the first plunger (col 7, lines 36-45).
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.
Claims 3-5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sarnoff et al (US 4689042 A) in view of Haber et al (US 5445614 A).
Regarding claim 3, Sarnoff et al disclose the limitations of claim 2 as discussed above, but fail to teach wherein the release slider transfers laterally to engage the plunger rod.
However, Haber et al disclose a drug mixing system (S) comprising a release slider (40) and a plunger rod (P1) wherein the release slider transfers laterally to engage the plunger rod (fig 2, col 3, lines 9-12).
Haber et al teach a release slider that locks a plunger rod in place. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Haber et al to have said release slider transfers laterally to engage the plunger rod as an alternative to lock said plunger rod with a reasonable expectation of success as taught by Haber et al.
Regarding claim 4, Sarnoff et al disclose the drug mixing system of claim 3,
Haber et al further teach wherein the release slider (40) is received in a plunger rod detent (39).
Regarding claim 5, Sarnoff et al disclose the drug mixing system of claim 3,
Haber et al further teach said system comprising a delivery collar (36), the delivery collar disposed laterally outward of the release slider (see figs 2-3).
Regarding claim 16, Sarnoff et al disclose the limitations of claim 2 as discussed above but fail to teach wherein the first container, second container, first plunger, second plunger and fluidic channel are configured to transfer a portion of the mixed medicament back and forth into each of the first and second containers multiple times through a plurality of transfer states.
However, Haber et al disclose a drug mixing system (S) comprising a first container (A1), a second container (A2), a first plunger (P1), a second plunger (P2) and a fluidic channel (66) wherein the first container, second container, first plunger, second plunger and fluidic channel are configured to transfer a portion of the mixed medicament back and forth into each of the first and second containers multiple times through a plurality of transfer states (col 4, lines 1-6).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the first container, second container, first plunger, second plunger and fluidic channel are configured to transfer a portion of the mixed medicament back and forth into each of the first and second containers multiple times through a plurality of transfer states as taught by Haber et al. This would provide the benefit of having a thorough complete mixture before injecting to the skin (col 4, lines 1-6).
Claim 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sarnoff et al (US 4689042 A) in view of Laugere et al (US 9889260 B2).
Regarding claim 11, Sarnoff et al disclose the drug mixing system of claim 2, and further teach a delivery assembly (16) having a delivery component (50) but fail to disclose said delivery assembly having a delivery seal opening component, wherein the delivery seal opening component is configured to cause a delivery seal to alter from a sealed state to an open state, thus allowing the delivery assembly to receive the mixed medicament.
However, Laugere et al disclose a drug system (10) comprising a delivery assembly (400) having a delivery seal opening component (408) and a delivery component (405), wherein the delivery seal opening component (408) is configured to cause a delivery seal (270) to alter from a sealed state to an open state, thus allowing the delivery assembly to receive the medicament (see figs 6 and 9, col 13 lines 21-29).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the needle assembly of Sarnoff et al and incorporate the teachings of Laugere et al to have said delivery assembly having a delivery seal opening component, wherein the delivery seal opening component is configured to cause a delivery seal to alter from a sealed state to an open state, thus allowing the delivery assembly to receive the mixed medicament. This would provide the benefit of having a delivery seal to ensure that the volume mix well from the first to the second container until ready for injection and alter said delivery seal from a sealed state to an open state, thus allowing the delivery assembly to receive the mixed medicament (col 11, lines 1-19).
Regarding claim 12, Sarnoff et al in view of Laugere et al disclose the drug mixing system of claim 11, wherein depressing the needle shield (40) assembly causes the delivery assembly to cause the delivery seal to alter from a sealed state to an open state (see fig 3, col 8, lines 43-52, pushing said needle shield 40 onto the skin of a patient would cause the modified delivery seal of Laugere et al to alter from a sealed state to an open state).
Allowable Subject Matter
Claim 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 8, Sarnoff et al fail to teach/disclose or render obvious “the actuation device is coupled to the release slider and upon actuating of the actuation device, the actuation device causes the release slider to engage with the first plunger, thus preventing the first plunger from moving inwardly or outwardly with respect to the housing” in addition to other limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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