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 .
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 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DE 4220301 (“Berg”).
Regarding Claim 1, Berg discloses a syringe (Fig. 2), comprising:
A syringe barrel (1) having an open proximal end (i.e. when the piston/plunger (9, 11 is removed) and a distal end comprising an outlet (4), the open proximal end of the syringe barrel opening into an interior (2) comprising a cylindrical wall (see Fig. 1) and an angled distal surface (3) terminating at the outlet, wherein the syringe barrel has an inner diameter (see Fig. 1);
A plunger rod (9) having proximal end (not shown) and a distal end (see Fig. 1); and
A plunger seal (8) having a proximal end (see where the piston rod is received) and a distal end (see 11), the proximal end of the plunger seal configured to be attached to the distal end of the plunger rod (see Fig. 1), and the distal end of the plunger seal configured to be inserted into the interior of the syringe barrel through the open proximal end (see Fig. 1), the plunger seal forming a seal with the cylindrical wall of the interior of the syringe barrel (see Fig. 1), the distal end of the plunger seal terminating at an angled distal surface (11);
wherein the angled distal surface of the syringe barrel is less the angled distal surface of the plunger seal (see Abstract, “The cone angle (13) of the piston tip (11) is larger than the cone angle (12) of the barrel space (2)” <<translation>> and Description Par. 3, “The cone angle 12 of the tip 3 of the cylinder space 2 is smaller than the cone angle 13 of the conical tip 11 of the piston seal 10” <<translation>>).
Regarding Claim 2, Berg discloses the angled distal surface of the plunger seal is in the form of a right circular cone (see Fig. 1, 3) having a second angle and wherein the angled distal surface of the syringe barrel is in the form of a right circular cone frustum (see Fig. 1, 2) having a first angle, the first angle being less than second angle (Description, Par. 3).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over DE 4220301 (“Berg”).
Regarding Claim 3, Berg discloses the invention substantially as claimed except for explicitly resolving the specific difference (or workable range) of the first angle and the second angle, however Berg does recognize the difference to be a result effective variable (Abstract; Par. 3) and given that deformation of the plunger seal is intended to eliminate this difference it must be understood that the difference cannot be too large or it could not be readily eliminated by deformation of the seal upon full depression. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the first and second angle of Berg to comprise a nominal difference of between 2 to 8 degrees, since it has been held that discovering the optimal or workable range for a result effective variable via routine and customary experimentation and optimization is obvious and that carrying forward the general concept of an invention to a specific conclusion in resolving it to practice to obtain a predictable and expected outcome (i.e. forming the two angles to be different to permit improved sealing) is obvious, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and In re Williams, 36 F.2d 436, 438 (CCPA 1929).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over DE 4220301 (“Berg”) as applied above, and further in view of CN 211157854 (“Sun”).
Regarding Claims 4 and 5, Berg discloses the invention substantially as claimed except for explicitly disclosing the specific values of the first and second angle. However, Sun discloses a related syringe piston having a second angle comprising an angled distal face (2) wherein Sun discloses that the taper angle of the distal cone can range from 110-130 degrees, with an exemplary value of 120 degrees (Par. 14).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the angle of the second angle (i.e. the cone angle of the piston) of Berg to range from 122-130 degrees (a range value within Applicant’s claimed range), as disclosed by Sun, in order assist in expelling retained fluid from the syringe barrel. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to form the first angle (i.e. the angle of the syringe barrel face) to be less than the second angle by a range of 2-8 degrees, thereby creating an overlapping obvious range of 120 degrees to 128 degrees – a range within Applicant’s claimed range. It has been held that discovering the optimal or workable range for a result effective variable via routine and customary experimentation and optimization is obvious and that carrying forward the general concept of an invention to a specific conclusion in resolving it to practice to obtain a predictable and expected outcome (i.e. forming the two angles to be different to permit improved sealing) is obvious, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and In re Williams, 36 F.2d 436, 438 (CCPA 1929).
Claim(s) 6-8, 10-11, 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over DE 4220301 (“Berg”) as applied above, and further in view of U.S. Publication No. 2005/0010175 (“Beedon”).
Regarding Claim 6, Berg discloses the plunger seal to comprise a proximal rib having a first outer diameter and a distal rib having a second outer diameter (see Fig. 1). However, Berg fails to disclose any relationship between the magnitude of the outer diameters (i.e. Berg is silent as to whether or not these diameters are the same or different). However, Beedon discloses a related syringe piston (24) which comprises a proximal rib (108) having a first outer diameter (D2) and a distal rib having a second outer diameter (D1), wherein the first outer diameter (D2) is greater than the second outer diameter (D1) (see Par. 41 – re: D2 is 9.5mm and D1 is 9.1mm) in order to adjust breakaway forces. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the proximal rib of Berg to be larger than the distal rib, as disclosed by Beedon, in order to adjust breakaway forces for the piston dependent upon particular application in aspiration and/or injection to ensure proper sealing while balancing the force required to manipulate the plunger.
Regarding Claim 7, Beedon discloses that a ratio of the first outer diameter to the second outer diameter is 1.044:1 (see 9.5mm vs. 9.1mm), a value within the claimed range. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the modified Berg with this same ratio, as disclosed by Beedon, in order to provide a size difference which has been demonstrated to provide suitable adjustments to breakaway forces in certain applications. Furthermore, it has been found that mere changes in size and proportion when conveying only expected and predictable results are obvious, requiring only routine and customary skill in the art, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), particularly when they involve only the carrying forward of the principle concepts of invention, see In re Williams, 36 F.2d 436, 438 (CCPA 1929).
Regarding Claim 8, Beedon discloses a ratio of the first outer diameter (9.5mm) to the inner diameter of the syringe barrel (8.75mm) is 1.086, i.e. a value within the range of 1.10:1 to 1.05:1. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the modified Berg with this same ratio, as disclosed by Beedon, in order to provide a size difference which has been demonstrated to provide suitable adjustments to breakaway forces in certain applications. Furthermore, it has been found that mere changes in size and proportion when conveying only expected and predictable results are obvious, requiring only routine and customary skill in the art, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), particularly when they involve only the carrying forward of the principle concepts of invention, see In re Williams, 36 F.2d 436, 438 (CCPA 1929).
Regarding Claim 10, Berg discloses the plunger seal further comprises one or more additional ribs between the proximal rib and the distal rib (see Fig. 3).
Regarding Claim 11, Berg discloses the invention substantially as claimed except that that the proximal end of the plunger seal is provided with a threaded bore and the distal end of the plunger rod is provided with matching threads. Rather Berg discloses that the distal end of the piston rod is merely pressed into the proximal end of the plunger seal. However, threaded connections are a notoriously well-known alternative for fixing a piston rod and plunger seal together in the prior art. For example, Beedon discloses such an interface (42, 44) as being known in the prior art. It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a threaded interconnection in the invention of Berg, as disclosed by Beedon, as an obvious design choice pursuant to simple substitution of known alternatives to obtain only a predictable and expected outcome, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding Claim 13, Berg discloses the invention substantially as claimed except for disclosing from what material the plunger seal is formed. However, Beedon discloses a related plunger seal which may be formed of an elastomer including chlorobutyl rubber, among others (Par. 64). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the plunger seal of the invention of Berg of a chlorobutyl rubber elastomer, as disclosed by Beedon, whereby it has been held that selecting a known material identified by the prior art for its suitability for such a purpose is obvious when it affects only predictable and expected results, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding Claims 14 and 15, Berg discloses the invention substantially as claimed except for disclosing from what material the barrel is formed. However, Beedon discloses a related barrels which may be formed of a rigid plastic material including cyclic olefin polymers (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the barrel of the invention of Berg of a cyclic olefin polymer, as disclosed by Beedon, whereby it has been held that selecting a known material identified by the prior art for its suitability for such a purpose is obvious when it affects only predictable and expected results, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding Claim 16, Berg discloses the invention substantially as claimed except that that the plunger seal comprises a fluoropolymer surface layer. However, Beedon discloses that such pistons may be provided with a PTFE fluoropolymer surface coating to improve lubricity (Par. 6). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the piston of Berg with a PTFE coating, as disclosed by Beedon, in order to improve lubricity.
Regarding Claim 17, Berg discloses a syringe (Fig. 2), comprising:
A syringe barrel (1) having an open proximal end (i.e. when the piston/plunger (9, 11 is removed) and a distal end comprising an outlet (4), the open proximal end of the syringe barrel opening into an interior (2) comprising a cylindrical wall (see Fig. 1) and an angled distal surface (3) terminating at the outlet, wherein the syringe barrel has an inner diameter (see Fig. 1);
A plunger rod (9) having proximal end (not shown) and a distal end (see Fig. 1); and
A plunger seal (8) having a proximal end (see where the piston rod is received) and a distal end (see 11), the proximal end of the plunger seal configured to be attached to the distal end of the plunger rod (see Fig. 1), and the distal end of the plunger seal configured to be inserted into the interior of the syringe barrel through the open proximal end (see Fig. 1), the plunger seal forming a seal with the cylindrical wall of the interior of the syringe barrel (see Fig. 1), the distal end of the plunger seal terminating at an angled distal surface (11);
wherein the angled distal surface of the syringe barrel is less the angled distal surface of the plunger seal (see Abstract, “The cone angle (13) of the piston tip (11) is larger than the cone angle (12) of the barrel space (2)” <<translation>> and Description Par. 3, “The cone angle 12 of the tip 3 of the cylinder space 2 is smaller than the cone angle 13 of the conical tip 11 of the piston seal 10” <<translation>>).
Berg discloses the angled distal surface of the plunger seal is in the form of a right circular cone (see Fig. 1, 3) having a second angle and wherein the angled distal surface of the syringe barrel is in the form of a right circular cone frustum (see Fig. 1, 2) having a first angle, the first angle being less than second angle (Description, Par. 3).
Berg discloses the plunger seal to comprise a proximal rib having a first outer diameter and a distal rib having a second outer diameter (see Fig. 1). However, Berg fails to disclose any relationship between the magnitude of the outer diameters (i.e. Berg is silent as to whether or not these diameters are the same or different). However, Beedon discloses a related syringe piston (24) which comprises a proximal rib (108) having a first outer diameter (D2) and a distal rib having a second outer diameter (D1), wherein the first outer diameter (D2) is greater than the second outer diameter (D1) (see Par. 41 – re: D2 is 9.5mm and D1 is 9.1mm) in order to adjust breakaway forces. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the proximal rib of Berg to be larger than the distal rib, as disclosed by Beedon, in order to adjust breakaway forces for the piston dependent upon particular application in aspiration and/or injection to ensure proper sealing while balancing the force required to manipulate the plunger.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over DE 4220301 (“Berg”) and U.S. Publication No. 2005/0010175 (“Beedon”) as applied above, and further in view of U.S. Publication No. 2011/0034882 (“Quinn”)
Regarding Claim 9, Berg, as modified, discloses the invention substantially as claimed except that that the proximal rib comprises a proximal facing surface having a first slope and a distal facing surface having a second slope, wherein the first slope is greater than the second slope. However, such configurations are known to the prior art. For example, Quinn describes a related plunger seal (Fig. 30A) comprising a proximal rib (351) wherein the rib comprises a proximal facing surface having a first slope which is greater than a second slope of a distal facing surface of the rib (see Fig. 30A). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the plunger seal of the invention of Berg to comprise a proximal rib having a proximal slope which is greater than the distal slope, as disclosed by Quinn, in order to select a known, useful and suitable shape to alter the sealing and sliding forces in a known and predictable manner. It has been held that mere changes in shape, particularly shapes known to the prior art, is an obvious design choice where such a shape confers only predicted and expected results, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Here the shape as claimed has been demonstrated to be a known, useful alternative shape found in the prior art and therefore obvious to employ in modification of Berg.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over DE 4220301 (“Berg”) as applied above, and further in view of U.S. Publication No. 2019/0350592 (“Bagaoisan”).
Regarding Claim 12, Berg discloses the invention substantially as claimed except that that the plunger rod and the barrel are provided with respective proximal flanges. However, such configurations are notoriously well-known in the art, see Bagaoisan (Fig. 2A – syringes 201 and 202), for providing a user with a suitable surface by which the grip and manipulate the syringe barrel and plunger. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a plunger flange at a proximal end of the plunger rod and a barrel flange at the proximal end of the syringe barrel of Berg, as disclosed by Bagaoisan, in order to provide suitable ergonomics for handling the syringe in the standard and customary manner.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2019/0350592 (“Bagaoisan”) in view of DE 4220301 (“Berg”).
Regarding Claim 18, Bagaoisan discloses a kit (300) comprising first (201) and second (202) syringes comprising:
A syringe barrel having an open proximal end and a distal end comprising an outlet (see Fig. 2A), the open proximal end of the syringe barrel opening into an interior comprising a cylindrical wall, wherein the syringe barrel has an inner diameter (see Fig. 2A);
A plunger rod having proximal end and a distal end (see Fig. 2A);
A plunger seal (not shown – see generally Par. 56, i.e. the “piston” is understood to comprise a seal to perform its function) having a proximal end and a distal end, the proximal end of the plunger seal configured to be attached to the distal end of the plunger rod, and the distal end of the plunger seal configured to be inserted into the interior of the syringe barrel through the open proximal end, the plunger seal forming a seal with the cylindrical wall of the interior of the syringe barrel (see Fig. 2A), and
A connector (204) that fluidically connects the outlet of the first syringe to the outlet of the second syringe (Par. 81 – Fig. 2A).
Bagaoisan is silent as to the internal geometry of the syringes as to the shape of the distal surface terminating at the outlet and the shape of the distal end of the plunger seal. However, Berg discloses a syringe (Fig. 2), comprising:
A syringe barrel (1) having an open proximal end (i.e. when the piston/plunger (9, 11 is removed) and a distal end comprising an outlet (4), the open proximal end of the syringe barrel opening into an interior (2) comprising a cylindrical wall (see Fig. 1) and an angled distal surface (3) terminating at the outlet, wherein the syringe barrel has an inner diameter (see Fig. 1);
A plunger rod (9) having proximal end (not shown) and a distal end (see Fig. 1); and
A plunger seal (8) having a proximal end (see where the piston rod is received) and a distal end (see 11), the proximal end of the plunger seal configured to be attached to the distal end of the plunger rod (see Fig. 1), and the distal end of the plunger seal configured to be inserted into the interior of the syringe barrel through the open proximal end (see Fig. 1), the plunger seal forming a seal with the cylindrical wall of the interior of the syringe barrel (see Fig. 1), the distal end of the plunger seal terminating at an angled distal surface (11);
wherein the angled distal surface of the syringe barrel is less the angled distal surface of the plunger seal (see Abstract, “The cone angle (13) of the piston tip (11) is larger than the cone angle (12) of the barrel space (2)” <<translation>> and Description Par. 3, “The cone angle 12 of the tip 3 of the cylinder space 2 is smaller than the cone angle 13 of the conical tip 11 of the piston seal 10” <<translation>>).
Berg discloses that this particular configuration is useful as it provides a geometry that can be more completely emptied (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the syringes of the invention of Bagaoisan to comprise an angled distal surface terminating at the outlet and the distal end of the plunger seal terminating at an angled distal surface wherein the angled distal surface of the syringe barrel is less than the angled distal surface of the plunger seal, as disclosed by Berg, in order to affect more complete emptying of the syringe as described by the prior art.
Regarding Claim 19 and 20, Bagaoisan discloses the first syringe is pre-filled with particulate suspension, wherein the particulate suspension is a liquid embolic composition (Par. 81).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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, KEVIN SIRMONS can be reached at (571) 272-4965. 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.
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/04/2026
Prosecution Insights