DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the AIA first to file provisions. 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 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.
Application Status
This office action is in response to the claims filed 5/23/2024.
Claims 1-18 and 20-21 are currently pending and being examined.
Information Disclosure Statement
The 2 IDS documents have been considered. See the attached PTO 1449 forms.
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 1-18 and 20-21 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 pre-AIA the applicant regards as the invention.
Claims 1 and 11 recite “aligning a stopper with a longitudinal axis of a syringe barrel” rendering the claims indefinite because the preambles of each claim introduce a stopper and a barrel, making it unclear if these are meant to be the same elements introduced in the preamble.
Claim 4 ends with “from the distal end” which lacks sufficient antecedent basis because there are two distal ends introduced in claim 1 (i.e., that of the barrel and that of the reservoir).
Claims 13, 16, and 17 each end with “from a distal end of the reservoir” which is indefinite and should be changed to “from the distal end of the reservoir” for sufficient antecedence.
Claims dependent on the above claims are therefore rejected as being dependent on a rejected 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.
Claims 11-12, 14-15, 18, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dix et al. US 2020/0155760.
Regarding claim 11:
Dix teaches a method of placing a stopper into a syringe barrel partially filled with a drug product, the method comprising:
aligning a stopper with a longitudinal axis of a syringe barrel, the syringe barrel including a proximal end, a distal end, and a reservoir (aligning in FIGS. 6A and 6B; cf. FIG. 2A for syringe barrel details), wherein the drug product (202) is disposed in a distal end of the reservoir at the distal end of the syringe barrel (see FIG. 3A);
applying a vacuum pressure to the reservoir of the syringe barrel ([0067], see “VAC” in FIG. 6B);
pushing the stopper with a plunger rod (608) into the reservoir of the syringe barrel to a first depth, thereby creating a pressure differential across the stopper, the plunger rod extending into the reservoir of the syringe barrel (see FIG. 6C; cf. [0069]);
disengaging the plunger rod from the stopper after pushing the stopper to the first depth, thereby causing the pressure differential across the stopper to displace the stopper to a second depth different than the first depth (e.g., last sentence of [0067]).
Regarding claim 12:
Dix teaches the method of claim 11, as discussed above, wherein applying the vacuum pressure to the syringe barrel includes applying a pressure in a range of approximately 70 mBar to approximately 85 mBar (see claim 17).
Regarding claim 14:
Dix teaches the method of claim 11, as discussed above, wherein applying the vacuum pressure at least partially coincides with pushing the stopper with the plunger rod into the reservoir of the syringe barrel (see FIGS. 6B and 6C).
Regarding claim 15:
Dix teaches the method of claim 11, as discussed above, wherein pushing the stopper includes pushing the stopper after applying the vacuum pressure to the syringe barrel (see FIG. 6C).
Regarding claim 18:
Dix teaches the method of claim 11, as discussed above, wherein aligning the stopper includes (b) compressing the stopper with a grip (502 or 602) adjacent to the proximal end of the syringe barrel and pushing the compressed stopper with the plunger rod through the grip and into the reservoir of the barrel (see FIGS. 5a-5D and 6a-6C; [0067], see “slightly compressed”).
Regarding claim 20:
Dix teaches the method of claim 11, as discussed above, wherein applying the vacuum pressure includes evacuating a headspace above the drug product in the syringe barrel and applying a vacuum at the proximal end of the syringe barrel (shown in FIG. 6B).
Regarding claim 21:
Dix teaches the method of claim 11, as discussed above, further comprising removing the plunger rod from the reservoir of the syringe barrel (e.g., last sentence of [0067]).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-10, 13, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Dix, as applied above.
Regarding claim 1:
Dix teaches a method of placing a stopper into a syringe barrel partially filled with a drug product, the method comprising:
aligning a stopper with a longitudinal axis of a syringe barrel, the syringe barrel including a proximal end, a distal end, and a reservoir (aligning in FIGS. 6A and 6B; cf. FIG. 2A for syringe barrel details), wherein the drug product (202) is disposed in a distal end of the reservoir at the distal end of the syringe barrel (see FIG. 3A);
applying a vacuum pressure to the reservoir of the syringe barrel ([0067], see “VAC” in FIG. 6B), the vacuum pressure in a range of approximately 70 mBar to approximately 85 mBar (see claim 17);
pushing the stopper with a plunger rod (608) into the reservoir of the syringe barrel to a first depth, thereby creating a pressure differential across the stopper (see FIG. 6C; cf. [0069]); and
disengaging the plunger rod from the stopper after pushing the stopper to the first depth, thereby causing the pressure differential across the stopper to displace the stopper to a second depth different than the first depth (e.g., last sentence of [0067]).
Dix does not explicitly teach the first depth being in a range of approximately 20 mm to approximately 40 mm from the distal end of the reservoir.
However, the exact length of the first depth would necessarily depend on the dimensions and fill level of the syringe, and it would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the method of Dix by pushing the stopper to any depth, including 20 mm to 40 mm from the distal end of the reservoir, such that the gap between the substance and the stopper is minimized, as intended by Dix (e.g., see [0065]).
Regarding claim 2:
Dix teaches the method of claim 1, as discussed above, wherein pushing the stopper includes inserting the plunger rod into the reservoir of the syringe barrel (see FIG. 6D).
Regarding claim 3:
Dix teaches the method of claim 1, as discussed above, wherein applying the vacuum pressure at least partially coincides with pushing the stopper with the plunger rod into the reservoir of the syringe barrel (see FIGS. 6B and 6C).
Regarding claim 5:
Dix teaches the method of claim 1, as discussed above, wherein pushing the stopper includes pushing the stopper after applying the vacuum pressure to the syringe barrel (see FIG. 6C).
Regarding claim 7:
Dix teaches the method of claim 1, as discussed above, wherein aligning the stopper includes placing the stopper adjacent to the proximal end of the syringe barrel before inserting the stopper into the reservoir of the syringe barrel (see FIG. 5B/6B).
Regarding claim 8:
Dix teaches the method of claim 1, as discussed above, wherein aligning the stopper includes compressing the stopper with a grip (502 or 602) adjacent to the proximal end of the syringe barrel and pushing the compressed stopper with the plunger rod through the grip and into the reservoir of the barrel (see FIGS. 5a-5D and 6a-6C; [0067], see “slightly compressed”).
Regarding claim 9:
Dix teaches the method of claim 1, as discussed above, wherein applying the vacuum pressure includes evacuating a headspace above the drug product in the syringe barrel and applying a vacuum at the proximal end of the syringe barrel (shown in FIG. 6B).
Regarding claim 10:
Dix teaches the method of claim 1, as discussed above, further comprising removing the plunger rod from the reservoir of the syringe barrel (e.g., last sentence of [0067]).
Regarding claims 4, 6, 13, 16, and 17:
Dix teaches the method of claims 3, 5, 11, 14, and 15, as discussed above, but does not explicitly teach wherein pushing the stopper includes pushing the stopper into the syringe barrel a distance in a range of approximately 23 mm to 32 mm, nor 30 mm to 35 mm, nor 20 mm to 40 mm from a distal end of the reservoir.
However, the exact length of the first depth would necessarily depend on the dimensions and fill level of the syringe, and it would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the method of Dix by pushing the stopper to any depth, including 20 mm to 40 mm from the distal end of the reservoir, such that the gap between the substance and the stopper is minimized, as intended by Dix (e.g., see [0065]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: for example, see FIG. 2 and col. 5, lines 18-26 of Jansen US 10,603,434; Griebel et al. US 2006/0168916; and others provided in the PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARIUSH SEIF whose telephone number is (408)918-7542. The examiner can normally be reached Monday-Friday 9:30 AM-6:00 PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNA KINSAUL can be reached at 571-270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DARIUSH SEIF/Primary Examiner, Art Unit 3731
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