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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1 – 12) in the reply filed on 10 August 2026 is acknowledged.
Claims 13 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 August 2026.
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:
228′ as shown in Figures 1A, 2, 3A, 3B, 3C, 3D, 3E, 3Ex, 3F, 3Fx, 3H, 3Hx,4A, 4B, 4Bd, and 4C.
233 as shown in Figure 2.
231 as shown in Figure 2, Figure 3F, and 3Fx.
292 as shown in Figure 2.
256a as shown in Figure 2.
257 as shown in Figure 2.
256b as shown in Figure 2.
251 as shown in Figure 2.
287 as shown in Figures 3X, 3Fx, and 3Hx.
231p as shown in Figure 3Fx.
231a as shown in Figure 3Fx.
330s as shown in Figures 4A, 4B, 4C, 5, 6, 7A, 7B, 7C, and 7D.
224i as shown in Figures 4A and 4B.
313 as shown in Figures 4A, 4B, and 4C.
224Iℓ as shown in Figure 4Bd.
424i as shown in Figure 5.
428′ as shown in Figures 5, 6, 7A, 7B, 7C, and 7D.
403 as shown in Figure 5.
428ℓ′ as shown in Figure 5.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
241 as recited in at least [0064].
255 as recited in at least [0067].
202e as recited in at least [0069].
261 as recited in at least [0070].
213 as recited in at least [0070].
264e′ as recited in at least [0072].
214 as recited in at least [0080].
202p as recited in at least [0086].
224p′ as recited in at least [0087].
228t′ as recited in at least [0089].
228t as recited in at least [0089].
413 as recited in at least [0093].
428t as recited in at least [0095].
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.
Specification
The disclosure is objected to because of the following informalities:
[0009] recites “to retain a portion of the second plunger rod in a positioned engaged with the retainer.” The Examiner believes the word “positioned” is incorrect and believes the word was intended to be “position.”
[0010] recite “In some aspects, the vial is adaptor configured to be releasably coupled…”. The Examiner finds the language “the vial is adaptor” to be confusing and suggests further review.
[0045] recites “or tris(hydroxymethyl)methacrylamides . The hydrophilic polymer.” The Examiner suggests removing the extra space between the word “tris(hydroxymethly)methacrylamides” and the period.
[0058] recites “a second rod of the multi-rod plunger assembly ejects a second amount of material from a o-rsecond chamber…”. The Examiner believes the word “o-rsecond” is misspelled and suggests further review.
[0058] recites “the first rod without ejects and/or aspirates material with respect to the first chamber.” The Examiner finds the language “the first rod without ejects and/or aspirates” to be confusing. Was the word “without” inadvertently included in this sentence? The Examiner suggests further review to clarify the sentence.
[0079] recites “co-pending provisional patent application ______________, titled…. [ATTORNEY DOCKET 2001.3125100]”. The Examiner requests further clarity regarding the co-pending provisional patent application number of this application and the docket number recited.
[0081] recites “the second plunger rod 230bdo not necessarily advance…”. The Examiner suggests amending this to provide a space between the reference numeral “230b” and the word “do.”
[0081] recites “co-pending provisional patent application ______________, titled…[ATTORNEY DOCKET 2001.3128100]”. The Examiner requests further clarity regarding the co-pending provisional patent application number of this application and the docket number recited.
[0084] recites “After the first component 204a has been injected into the third chamber 102c…”. The Examiner believes this is the incorrect reference numeral for the third chamber. Additionally reference numeral 102 is not located in the Drawing. Therefore, the Examiner suggests amending reference numeral “102c” to be “202c.”
[0085] recites “above incorporated provisional patent application ______________, [ATTORNEY DOCKET 2001.3128100]”. The Examiner requests further clarity regarding the co-pending provisional patent application number of this application and the docket number recited.
[0089] recites “the component 202b from within the second chamber 202b.” This is the incorrect reference numeral for the component. The Examiner believes the correct reference numeral for the component is 204b.
[0091] recites “co-pending provisional patent application ______________, titled…[ATTORNEY DOCKET 2001.3127100]”. The Examiner requests further clarity regarding the co-pending provisional patent application number of this application and the docket number recited.
[0091] recites “above incorporated provisional patent application ______________, [ATTORNEY DOCKET 2001.3125100]”. The Examiner requests further clarity regarding the co-pending provisional patent application number of this application and the docket number recited.
Appropriate correction is required.
Claim Objections
Claims 1, 7, and 12 are objected to because of the following informalities:
Claim 1 recites “barrel.” The Examiner suggests amending this to recite “a barrel” to provide the proper antecedent basis for this limitation.
Claim 1 recites “said distal end of first plunger rod.” The Examiner suggests amending this to recite “said distal end of the first plunger rod” to provide the proper antecedent basis for this limitation.
Claim 7 recites “positioned engaged.” The Examiner believes the word “positioned” should be replaced with the word “position” to clarify the claim.
Claim 12 recites “positioned engaged.” The Examiner believes the word “positioned” should be replaced with the word “position” to clarify the claim.
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 3 – 9 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 1 recites:
…
a portion of said first plunger rod and a portion of said second plunger rod move together with respect to said barrel; and
…
Claim 3 recites:
The multi-chamber device of claim 2, wherein a portion of said first plunger rod is coupled with a portion of said second plunger rod so that said portion of said first plunger rod and said portion of said second plunger rod move together.
Claim 3 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined if the portion of the first plunger rod that is coupled with the portion of the second plunger rod is the same portion of the first and second plunger rods that move together as recited in Claim 1 or separate portions.
Claims 4 – 9 are rejected under 35 U.S.C. § 112(b) because of their dependency on Claim 3.
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.
Claim(s) 1 – 6, 10, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jamiolkowski et al. (US 2015/0250463 A1) (hereinafter referred to as “Jamiolkowski”).
With regard to claim 1, Jamiolkowski discloses (Figures 17A – 17B) a multi-chamber device (800) (see [0167]) comprising:
barrel (801, 810b, 810c) (see [0167]) defining a first chamber (C2) (see [0168]) and a second chamber (C3) (see [0168]) fluidly isolated from each other (see Figure 17A); and
a plunger assembly having a first plunger rod (855b and the portion of the bar 862 which connects to the rod 855b) (see [0167] and Figure 17B) with a distal end (831) (see [0167]) extendable with respect to said first chamber (see Figure 17A), and a second plunger rod (855c and the portion of the bar 862 that connects to the rod 855c) (see [0167]) with a distal end (831) (see [0167]) extendable with respect to said second chamber (see Figure 17A); wherein:
a portion of said first plunger rod (see the portion of the bar 862 that connects to the rod 855b) and a portion of said second plunger rod (see the portion of the bar 862 that connects to the rod 855c) move together with respect to said barrel (see Figures 17A – 17B where the bar 862 moves); and
a portion of said first plunger rod (see the rod 855b) is independently movable (the rod 855b is independently movable because as the rod 855b is depressed along gap G no movement of the rod 855c occurs) with respect to a portion (see the rod 855c) of said second plunger rod to advance said distal end of first plunger rod with respect to said barrel a first extent (see Examiner annotated Figures 17A – 17B below; hereinafter referred to as “Fig. A”) and to advance said distal end of said second plunger rod with respect to said barrel a second extent (see Fig. A below) different from said first extent (see Figures 17A – 17B and [0168]).
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With regard to claim 2, Jamiolkowski discloses the claimed invention of claim 1, and Jamiolkowski further discloses wherein said portion of said first plunger rod and said portion of said second plunger rod which are independently movable are said distal end (see at the rod 855b) of said first plunger rod (855b and the portion of the bar 862 which connects to the rod 855b) and said distal end (see at the rod 855c) of said second plunger rod (855c and the portion of the bar 862 which connects to the rod 855c).
With regard to claim 3, Jamiolkowski discloses the claimed invention of claim 2, and Jamiolkowski further discloses wherein a portion (see the portion of the bar 862 which is connected to the rod 855b) of said first plunger rod (855b and the portion of the bar 862 which connects to the rod 855b) is coupled with a portion (see the portion of the bar 862 which is connected to the rod 855c) of said second plunger rod (855c and the portion of the bar 862 which connects to the rod 855c) so that said portion of said first plunger rod and said portion of said second plunger rod move together (see Figures 17A – 17B and [0168]).
With regard to claim 4, Jamiolkowski discloses the claimed invention of claim 3, and Jamiolkowski further discloses wherein said portion of said first plunger rod (855b and the portion of the bar 862 which connects to the rod 855b) and said portion of said second plunger rod (855c and the portion of the bar 862 which connects to the rod 855c) which move together are a proximal end (see the portion of the bar 862 which is connected to the rod 855b) of said first plunger rod and a proximal end of said second plunger rod (see the portion of the bar 862 which is connected to the rod 855c in Figure 17B).
With regard to claim 5, Jamiolkowski discloses the claimed invention of claim 4, and Jamiolkowski further discloses said second plunger rod (855c and the portion of the bar 862 which connects to the rod 855c) comprises a proximal plunger rod (see the portion of the bar 862 which connects to the rod 855c) and a distal plunger rod (see the rod 855c) axially movable with respect to each other (see Figures 17A – 17B); and
said proximal plunger rod and said first plunger rod (855b and the portion of the bar 862 which connects to the rod 855b) are coupled together to move together (see Figures 17A – 17B, [0167], and [0168]).
With regard to claim 6, Jamiolkowski discloses the claimed invention of claim 5, and Jamiolkowski further discloses wherein said proximal plunger rod (see the portion of the bar 862 which connects to the rod 855c) and said distal plunger rod (see the rod 855c) are selectively movable into a position in which said proximal plunger rod and said distal plunger rod are engaged to move together (see Figures 17A – 17B, [0167], and [0168]).
With regard to claim 10, Jamiolkowski discloses the claimed invention of claim 1, and Jamiolkowski further discloses said second plunger rod (855c and the portion of the bar 862 which connects to the rod 855c) comprises a proximal plunger rod (see the portion of the bar 862 which connects to the rod 855c) and a distal plunger rod (see the rod 855c) axially movable with respect to each other (see Figures 17A – 17B); and
said proximal plunger rod and said first plunger rod (855b and the portion of the bar 862 which connects to the rod 855b) are coupled together to move together (see Figures 17A – 17B, [0167], and [0168]).
With regard to claim 11, Jamiolkowski discloses the claimed invention of claim 10, and Jamiolkowski further discloses wherein said proximal plunger rod (see the portion of the bar 862 which connects to the rod 855c) and said distal plunger rod (see the rod 855c) are selectively movable into a position in which said proximal plunger rod and said distal plunger rod are engaged to move together (see Figures 17A – 17B, [0167], and [0168]).
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.
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.
Claim(s) 7, 8, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamiolkowski in view of Wirt et al. (US 6,458,095 B1) (hereinafter referred to as “Wirt”).
With regard to claim 7, Jamiolkowski discloses the claimed invention of Claim 6, however, Jamiolkowski is silent with regards to the multi-chamber device further comprising a retainer coupled to said barrel to retain a portion of said second plunger rod in a positioned engaged with said retainer.
Nonetheless Wirt, which is within the analogous art of dispensers having a housing with multiple cavities (see abstract and title), teaches (see Figure 13) the multi-chamber device (20B) further comprising a retainer (129) coupled to said barrel (30B) to retain a portion of said second plunger rod (62B) in a positioned engaged with said retainer (see Col. 11, lines 12 – 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the multi-chamber device of Jamiolkowski in view of a teaching of Wirt such that the multi-chamber device further comprising a retainer coupled to said barrel to retain a portion of said second plunger rod in a positioned engaged with said retainer. One of ordinary skill in the art would have been motivated to make this modification because Wirt teaches that the retainer protects and supports the containers of the multi-chamber device to ensure that they do not break. See Col. 11, lines 12 – 26 of Wirt.
The multi-chamber device of Jamiolkowski modified in view of a teaching of Wirt will hereinafter be referred to as the multi-chamber device of Jamiolkowski and Wirt.
With regard to claim 8, the multi-chamber device of Jamiolkowski and Wirt teaches the claimed invention of claim 7, and the multi-chamber device of Jamiolkowski and Wirt further teaches said retainer (129 of Wirt) engages said distal plunger rod (855c of Jamiolkowski) in a distally advanced position (see Figure 17A) with respect to said second chamber (C3 of Jamiolkowski) of said barrel (801, 810b, 810c of Jamiolkowski).
With regard to claim 12, Jamiolkowski discloses the claimed invention of Claim 1, however, Jamiolkowski is silent with regards to the multi-chamber device further comprising a retainer coupled to said barrel to retain a portion of said second plunger rod in a positioned engaged with said retainer.
Nonetheless Wirt, which is within the analogous art of dispensers having a housing with multiple cavities (see abstract and title), teaches (see Figure 13) the multi-chamber device (20B) further comprising a retainer (129) coupled to said barrel (30B) to retain a portion of said second plunger rod (62B) in a positioned engaged with said retainer (see Col. 11, lines 12 – 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the multi-chamber device of Jamiolkowski in view of a teaching of Wirt such that the multi-chamber device further comprising a retainer coupled to said barrel to retain a portion of said second plunger rod in a positioned engaged with said retainer. One of ordinary skill in the art would have been motivated to make this modification because Wirt teaches that the retainer protects and supports the containers of the multi-chamber device to ensure that they do not break. See Col. 11, lines 12 – 26 of Wirt.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamiolkowski and Wirt as applied to Claim 8 above and in further view of Osinga (US 2007/0225655 A1).
With regard to claim 9, the multi-chamber device of Jamiolkowski and Wirt teaches the claimed invention of claim 8, however, Jamiolkowski is silent with regards to wherein said proximal plunger rod and said distal plunger rod are selectively movable into a position in which said proximal plunger rod and said distal plunger rod are engaged to move together upon proximally retracting said proximal plunger rod with respect to said distal plunger rod.
Nonetheless Osinga, which is within the analogous art of medicament applicators (see abstract and title), teaches wherein said proximal plunger rod (122) and said distal plunger rod (120) are selectively movable into a position in which said proximal plunger rod and said distal plunger rod are engaged to move together upon proximally retracting said proximal plunger rod with respect to said distal plunger rod (see Figures 3, 5, and 7; see [0062] and [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the multi-chamber device of Jamiolkowski and Wirt in view of a teaching of Osinga such that said proximal plunger rod and said distal plunger rod are selectively movable into a position in which said proximal plunger rod and said distal plunger rod are engaged to move together upon proximally retracting said proximal plunger rod with respect to said distal plunger rod. One of ordinary skill in the art would have been motivated to make this modification because Osinga teaches that this construction helps avoid premature activation of the plunger assembly and can inhibit the piston portion from accidentally sliding towards the dispensing outlet and causing premature medicament discharge. See [0067] of Osinga.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Meron (US 2013/0172823 A1).
Arocha (US 2015/0065993 A1).
Schabbach et al. (US 2020/0276388 A1).
Lowin et al. (US 4,636,202 A).
Rissman et al. (US 8,376,989 B2).
Bar-Shalom et al. (US 2015/0190584 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/01/2026
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