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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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) 1-2, 8-9, 13, 17, and 19-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silverman et al. (Pub. No.: US 2020/0146280 A1).
Regarding claim 1, Silverman discloses (fig. 1A-1B) a syringe (device 100) for cryopreservation (¶ 0037), comprising:
A barrel (200) having a spout (second exit orifice 252) and an opening (barrel orifice 220) (¶ 0038);
A gasket (plunger 400) slidably accommodated in the barrel (¶ 0044);
A plunger (plunger rod 300) connected to the gasket (¶ 0039); and
A cap (needle end cap 500) that seals the spout of the barrel (¶ 0038),
Wherein the opening of the barrel is sealed only with the gasket (¶ 0038).
Regarding claim 2, Silverman discloses wherein the plunger is connected to the gasket while having a gap from the barrel (see plurality of ridges 425, ¶ 0039).
Regarding claim 8, Silverman discloses wherein the gasket comprises two or more gasket lips (plurality of ridges 425, ¶ 0039).
Regarding claim 9, Silverman discloses wherein the barrel and the gasket may be manufactured from the same resin such as polypropylene (¶ 0042). Thus, Silverman discloses that a ratio (X/Y) of a shrinkage rage (X) at which a resin forming the barrel is cooled from a room temperature to a certain temperature to a shrinkage rate (Y) at which a resin forming the gasket is cooled from the room temperature to the certain temperature is 1 which falls within the claimed range of 1<=(X/Y)<1.3.
Regarding claim 13, Silverman discloses wherein the syringe further comprises a finger grip (barrel flange 215), and the outer circumferential surface of the finger grip and the outer circumferential surface of the barrel are partially substantially flush with each other (fig. 1B).
Regarding claim 17, Silverman discloses wherein the syringe stores a cell (¶ 0022), a nucleic acid or a protein.
Regarding claim 19, Silverman discloses wherein the syringe is used in regenerative medicine (¶ 0022).
Regarding claim 20, Silverman discloses wherein the syringe is used at -196 C for cryopreservation (¶ 0031) which falls within the claimed range of -80 C or less.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 21, Silverman discloses wherein the syringe is used at about -196 C for cryopreservation (¶ 0031) which falls within the claimed range of -150C or less.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 22, Silverman discloses a prefilled syringe for cryopreservation, wherein the prefilled syringe stores a content in the syringe according to claim 1 (¶ 0034-¶ 0035).
Regarding claim 23, Silverman discloses wherein the prefilled syringe is used at -196 C for cryopreservation (¶ 0031) which falls within the claimed range of -80 C or less.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 24, Silverman discloses wherein the prefilled syringe is used at -196 C for cryopreservation (¶ 0031) which falls within the claimed range of -150 C or less.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 25, Silverman discloses a method of cryopreserving a subject substance comprising cryopreserving the subject substance in the syringe according to claim 1 (¶ 0034-¶ 0035, ¶ 0037).
Regarding claim 26, Silverman discloses wherein the cryopreservation is a cryopreservation at -196 C (¶ 0034) which falls within the claimed range of -80 C or less.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
Regarding claim 27, Silverman discloses wherein the cryopreservation is a cryopreservation at -196 C (¶ 0034) which falls within the claimed range of -150 C or less.
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman, as applied to claim 1 above, and further in view of Imbert (US Pat. No.: 5,624,402).
Regarding claim 3, Silverman discloses fails to disclose wherein the cap comprise a substrate, a projection protruding from an inner center of the substrate and fitted into an inner circumferential surface of the spout of the barrel, and a mantle tube fitted from a circumferential edge of the substrate to an outer circumferential surface of the spout of the barrel, wherein the mantle tube of the cap protrudes towards the barrel side more than the projection of the cap.
Imbert teaches (fig. 1-5) a syringe (10) and thus in the same field of endeavor, comprising: a cap (inner cap 56), wherein the cap comprises a substrate, a projection (stopper 67) protruding from an inner center of the substrate and fitted into an inner circumferential surface of a spout of a barrel (tip 22) (col. 4, ln. 30-32), and a mantle tube (tip engaging portion 64) fitted from a circumferential edge of the substrate to an outer circumferential surface of the spout of the barrel (fig. 4), wherein the mantle tube of the cap protrudes towards the barrel side more than the projection of the cap (fig. 4), the cap configured to tightly engage the spout and provide an enhanced sealing ability (col. 4, ln. 20-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap of Silverman such that it comprises a substrate, a projection protruding from an inner center of the substrate and fitted into an inner circumferential surface of the spout of the barrel, and a mantle tube fitted from a circumferential edge of the substrate to an outer circumferential surface of the spout of the barrel, wherein the mantle tube of the cap protrudes towards the barrel side more than the projection of the cap, as taught by Imbert, in order to configure the cap to tightly engage the spout and provide an enhanced sealing ability (Imbert col. 4, ln. 20-33).
Claim(s) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman, as applied to claim 1 above, and further in view of Okihara (Pub. No.: US 2019/0388626 A1).
Regarding claim 6, Silverman fails to disclose wherein a maximum load when the gasket is slid in the barrel at a speed of 100 mm/minute is 8N or less.
However, the current specification recites that the barrel and the gasket can be formed from a fluororesin (¶ 0038).
Silverman teaches the gasket comprising a fluororesin (PTFE, ¶ 0042).
Okihara teaches (fig. 1) a syringe (10) and thus in the same field of endeavor comprising a barrel (12) formed from a fluororesin (¶ 0044), such material being suitable for forming a syringe barrel (¶ 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrel of Silverman such that it is formed from a fluororesin, as taught by Okihara, as such material is suitable for forming a syringe barrel (Okihara ¶ 0044).
Accordingly, the syringe of Silverman in view of Okihara comprising a barrel and gasket being formed of fluororesin is identical to the claimed invention and inherently has a maximum load when the gasket is slid in the barrel at a speed of 100 mm/minute is 8N or less.
It is further noted: “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985)”.
Regarding claim 10, Silverman fails to disclose wherein the barrel is formed from a material having an absorbed energy in a tensile impact test under liquid nitrogen cooling conditions of 0.23 J or more.
However, the current specification recites that the barrel can be formed from a fluororesin (¶ 0038).
Okihara teaches (fig. 1) a syringe (10) and thus in the same field of endeavor comprising a barrel (12) formed from a fluororesin (¶ 0044), such material being suitable for forming a syringe barrel (¶ 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the barrel of Silverman such that it comprises a fluororesin, as taught by Okihara, as such material is suitable for forming a syringe barrel (Okihara ¶ 0044).
Accordingly, the syringe of Silverman in view of Okihara comprising a barrel formed of a fluororesin is identical to the claimed invention and inherently is formed from a material having an absorbed energy in a tensile impact test under liquid nitrogen cooling conditions of 0.23 J or more.
It is further noted: “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985)”.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman, as applied to claim 1 above, and further in view of Ma (Pub. No.: US 2019/0366004 A1).
Regarding claim 7, Silverman fails to disclose wherein a ratio (B/A) of a diameter (b) of the gasket to an inner diameter (A) of the barrel is 1<=(B/A)<1.050.
Ma teaches (fig. 1) a syringe (medical device 100) and thus in the same field of endeavor, comprising: a barrel (110) and a gasket (stopper 140), wherein a ratio (B/A) of a diameter (b) of the gasket to an inner diameter (A) of the barrel is 1 (¶ 0060) which falls within the claimed range of 1<=(B/A)<1.050, such ratio allowing for a fluid-tight seal between the stopper and an interior surface of the barrel (¶ 0060).
“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (see MPEP §2131.03.I).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gasket and the barrel of Ma such that a ratio (B/A) of a diameter (b) of the gasket to an inner diameter (A) of the barrel is 1<=(B/A)<1.050, as taught by Ma, as such ratio allows for a fluid-tight seal between the stopper and an interior surface of the barrel (Ma ¶ 0060).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman, as applied to claim 1 above, and further in view of Takeuchi et al. (Pub. No.: US 2019/0054241 A1).
Regarding claim 16, Silverman fails to disclose wherein the syringe is further stored in an outer bag.
Takeuchi teaches (fig. 1-2) a syringe (10) and thus in the same field of endeavor, wherein the syringe is further stored in an outer bag (package 12, ¶ 0037) in order to configure the syringe to be sterilized (¶ 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe of Silverman such that it is further stored in an outer bag, as taught by Takeuchi, in order to configure the syringe to be sterilized (Takeuchi ¶ 0047).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yaghmour (Pub. No.: US 2006/0019233 A1) discloses a syringe for cryopreservation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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