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 .
Specification
The disclosure is objected to because of the following informalities: Par. [0008] and [0045] are objected to because they appear to recite typographical errors where the degree symbol (°) appears to have been substituted with the numeral zero (0) – see 1200 to 160°, 1220 to 168°, 1320 to 152°, 1360 to 156°. The values of 1200, 1220, 1320, and 1360 to not appear to make sense if understood to be degrees, e.g. 1200 degrees is more than three whole revolutions.
Appropriate correction is required.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 appears to have substituted the degree symbol with the numeral zero, i.e. “1200” should be understood as 120 degrees. 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.
Claim(s) 1, 17, and 18 is/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.
Regarding Claims 1, 17, and 18 Applicant recites the phrase “more acute”. However, based on the limited use of this phrase in the specification (see only the Abstract and Par. [0007] where the phrase is not linked to any specific examples or embodiments) the metes and bounds of this comparison are not immediately clear. It is unclear if applicant is using the phrase “acute” as in terms of an “acute angle” (although all the examples are obtuse angles) or “acute” in terms of comparative “sharpness”, e.g. the angled distal surface of the syringe barrel is a sharper angle (re: smaller – i.e. further away from 180 degrees which would be a flat face) than the angled distal surface of the plunger seal. The specification recites embodiments (see Fig. 1A and 1B) where the angle of the barrel face is sharper (see Fig. 1A) or flatter (Fig. 1B) than the angle of the piston face. However, if Claim 1 is understood to recite that the angle of the barrel face is sharper than that of the plunger seal, Claim 2 requires the barrel face to be a larger angle than that of the piston face. As such, it is not immediately clear what arrangement (see Fig. 1A versus 1B) Applicant is attempting to claim. Since these configurations are disclosed to “contrast” (Par. 19) one another, it is not understood that the claims would be generic to BOTH configurations.
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, 11, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 203227095 (“Wang”)
Regarding Claim 1, Wang discloses a syringe (Fig. 2) comprising:
A syringe barrel (1) having an open proximal end (i.e. the end receiving the plunger/piston 2, 7) and a distal end (6) comprising an outlet (4, 5), the open proximal, end of the syringe barrel opening into an interior (see the receipt of the piston/plunger) comprising a cylindrical wall (see Fig. 2) and an angled distal surface (6) terminating at the outlet, wherein the syringe barrel has an inner diameter (see Fig. 2);
A plunger rod (2) having proximal end (i.e. the thumb flange) and a distal end (10); and
A plunger seal (3, 7) having a proximal end (3) and a distal end (see at 7), the proximal end of the plunger seal configured to be attached to the distal end of the plunger rod (see Fig. 2), 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. 2), the plunger seal forming a seal with the cylindrical wall of the interior of the syringe barrel (see Fig. 2), the distal end of the plunger seal terminating at an angled distal surface (7);
wherein the angled distal surface of the syringe barrel is more acute (re: larger) than the angled distal surface of the plunger seal (see Fig. 2 – Abstract, Par. 7, 14, 16).
Regarding Claim 2, Wang discloses the distal surface (7) of the plunger seal is in the form of a right circular cone having a first angle (see Fig. 2) and wherein the angled distal surface (6) of the syringe barrel is in the form of a right circular cone frustum having a second angle (see Fig. 2), wherein the first angle is less than the second angle (see Fig. 2 – Abstract, Par. 7, 14, 16).
Regarding Claim 11, Wang discloses 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 (see Fig. 2).
Regarding Claim 12, Wang discloses a plunger flange is provided at a proximal end of the plunger rod and a barrel flange is provided at the proximal end of the syringe barrel (see Fig. 2).
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 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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 203227095 (“Wang”).
Regarding Claim 3, Wang discloses that the difference between the first angle and the second angle ranges from 0 to 5 degrees (see Fig. 2 – Abstract, Par. 7, 14, 16). It has been held that when a prior art range substantially overlaps with a claimed range a prima facie case of obviousness exists, wherein it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the angle difference of the invention of Wang to range between 2 to 5 degrees (inclusive), a range which falls wholly within the range claimed by Applicant, thereby only achieving the obvious, predictable, and expected results of selecting specific values within the range identified as suitable by Wang.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 203227095 (“Wang”) as applied above, and further in view of CN 211157854 (“Sun”)
Regarding Claims 4 and 5, Wang discloses the invention substantially as claimed except for explicitly disclosing the specific values of the first and second angle. While Wang resolves their range of difference (0 to 5 degrees with 2-5 degrees comprising a suitable, obvious range), there is no recitation as to the actual angles themselves, only the difference. However, Sun discloses a related syringe piston having 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 first angle (i.e. the cone angle of the piston) of Wang to range from 120-130 degrees (a range value within Applicant’s claimed range), as disclosed by Sun, in order assist in expelling retained fluid from the syringe barrel. Based on the difference in angles recited by Wang, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the second angle to be 2-5 degrees larger than the first angle (re: 122-135 degrees), as disclosed by Wang, in order to prevent backflow as discussed by Wang utilizing an acceptable range of piston dimensions known to the prior art (see Sun).
Claim(s) 6-10, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 203227095 (“Wang”) as applied above, and further in view of U.S. Publication No. 2005/0010175 (“Beedon”)
Regarding Claim 6, Wang 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. 3). However, Wang fails to disclose any relationship between the magnitude of the outer diameters (i.e. Wang 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 Wang 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 Wang 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 Wang 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 9, Wang discloses the proximal rib comprises a proximal facing surface having a first slope and a distal facing surface having a second slope (see Fig. 3), wherein the first slope is greater than the second slope.
Regarding Claim 10, Wang discloses the plunger seal further comprises one or more additional ribs between the proximal rib and the distal rib (see Fig. 3).
Regarding Claim 16, Wang 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 Wang with a PTFE coating, as disclosed by Beedon, in order to improve lubricity.
Regarding Claim 17, Wang discloses a syringe (Fig. 2) comprising:
A syringe barrel (1) having an open proximal end (i.e. the end receiving the plunger/piston 2, 7) and a distal end (6) comprising an outlet (4, 5), the open proximal, end of the syringe barrel opening into an interior (see the receipt of the piston/plunger) comprising a cylindrical wall (see Fig. 2) and an angled distal surface (6) terminating at the outlet, wherein the syringe barrel has an inner diameter (see Fig. 2);
A plunger rod (2) having proximal end (i.e. the thumb flange) and a distal end (10); and
A plunger seal (3, 7) having a proximal end (3) and a distal end (see at 7), the proximal end of the plunger seal configured to be attached to the distal end of the plunger rod (see Fig. 2), 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. 2), the plunger seal forming a seal with the cylindrical wall of the interior of the syringe barrel (see Fig. 2), the distal end of the plunger seal terminating at an angled distal surface (7), the plunger seal comprising a proximal rib having a first outer diameter (see Fig. 3) and a distal rib having a second outer diameter (see Fig. 3);
wherein the angled distal surface of the syringe barrel is more acute (re: larger) than the angled distal surface of the plunger seal (see Fig. 2 – Abstract, Par. 7, 14, 16), the distal surface (7) of the plunger seal is in the form of a right circular cone having a first angle (see Fig. 2) and wherein the angled distal surface (6) of the syringe barrel is in the form of a right circular cone frustum having a second angle (see Fig. 2), wherein the first angle is less than the second angle (see Fig. 2 – Abstract, Par. 7, 14, 16).
Wang fails to disclose any relationship between the magnitude of the outer diameters (i.e. Wang 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 Wang 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) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 203227095 (“Wang”) as applied above, and further in view of U.S. Publication No. 2006/0178643 (“Sudo”)
Regarding Claim 13, Wang discloses the invention substantially as claimed except for disclosing the material of which the plunger seal is formed. However, Sudo discloses that EPDM, brominated butyl rubber, chlorinated butyl rubber are suitable material for the construction of such syringe pistons (Par. 27). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the piston of Wang to comprise one of bromobutyl rubber, chlorobutyl rubber, or EPDM, as disclosed by Sudo, whereby it has been held that selecting a known material based upon a recognized art suitability of that material for a particular purpose is obvious conveying only predictable and expected results, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding Claims 14 and 15, Wang discloses the invention substantially as claimed except that for disclosing the material of which the barrel is formed. However, Sudo discloses that such syringe barrels may be formed of rigid plastic polymers such as polyethylene or cyclic olefin polymers (Par. 40, 55). 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 Wang to comprise one of polyethylene or cyclic olefin polymer, as disclosed by Sudo, whereby it has been held that selecting a known material based upon a recognized art suitability of that material for a particular purpose is obvious conveying only predictable and expected results, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 203227095 (“Wang”) in view of U.S. Publication No. 2019/0350592 (“Bagaoisan”)
Regarding Claim 18, Wang discloses a syringe (Fig. 2) comprising:
A syringe barrel (1) having an open proximal end (i.e. the end receiving the plunger/piston 2, 7) and a distal end (6) comprising an outlet (4, 5), the open proximal, end of the syringe barrel opening into an interior (see the receipt of the piston/plunger) comprising a cylindrical wall (see Fig. 2) and an angled distal surface (6) terminating at the outlet, wherein the syringe barrel has an inner diameter (see Fig. 2);
A plunger rod (2) having proximal end (i.e. the thumb flange) and a distal end (10); and
A plunger seal (3, 7) having a proximal end (3) and a distal end (see at 7), the proximal end of the plunger seal configured to be attached to the distal end of the plunger rod (see Fig. 2), 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. 2), the plunger seal forming a seal with the cylindrical wall of the interior of the syringe barrel (see Fig. 2), the distal end of the plunger seal terminating at an angled distal surface (7);
wherein the angled distal surface of the syringe barrel is more acute (re: larger) than the angled distal surface of the plunger seal (see Fig. 2 – Abstract, Par. 7, 14, 16).
Wang discloses the invention substantially as claimed except that that the syringe is provided as part of a kit comprise two syringes of such a type with a connector which fluidly connects the outlet of the first syringe to the outlet of the second syringe. However, Bagaoisan discloses that it is known to provide multiple syringes (201, 202) of the same type together as a kit with a connector (304) to fluidly connect the respective outlets of the syringes together (see Fig. 2A) in order to permit the contents of a pre-filled syringe to be transferred and suitably mixed (Par. 81).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a kit comprising multiple syringes of the type of Wang together with a connector for allowing the syringes to be connected to one another, as disclosed by Bagaoisan, in order to allow for the mixing of an embolic particular suspension material between syringe bodies thereby rendering the agent suitable for delivery during a medical procedure.
Conclusion
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 02/04/2026