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
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 34, 36, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tartaglia (US 4484915 A).
Regarding claim 34, Tartaglia discloses an aspiration syringe (abstract), comprising: a barrel (cylinder 10, Fig. 1); a plunger disposed in the barrel (plunger 22, Fig. 1); and an aspiration mechanism including: a thumb-support member bonded to a proximal portion of the barrel (the portion of first flange 12 in-between dotted lines 16, Fig. 2; flange 12 is being interpreted as bonded to the proximal portion of cylinder 10, Col 2 lines 5-6; lines 52 of Fig. 3 depict how squeezing is to occur for aspiration to ensue; considering single hand operation, Col 1 lines 22-23, a thumb could be supported on flange 12), the thumb-support member coupled to or formed with a proximal annular member that encircles the barrel (the portion of first flange 12 in-between dotted lines 16 is formed with the remainder of flange 12 to be annular and encircling cylinder 10, Fig. 1-2); and
a syringe housing disposed around the barrel (elements 32 and second flange 30 are disposed around cylinder 10, Col 2 lines 23-32 & Fig 2) but for a single longitudinal gap within which the thumb-support member moves relative to the syringe housing when the syringe housing is slid over the barrel (elements 32 are spaced apart creating a single longitudinal gap that allows flange 12 to slide with respect to flange 30 during aspiration and/or injection, see Col 2 lines 20-35 & Fig. 1-3; elements 32 and flange 30 are disposed around cylinder 10 except for the single longitudinal gap), the syringe housing including a proximal portion coupled to a proximal portion of the plunger (proximal portions of elements 32 are operatively coupled to head 28 of plunger 22, Fig. 1 and 2) and
a distal portion terminating with a flange incorporated into a finger-support member (second flange 30 is being interpreted as a finger-support member, Col 2 lines 33-35 & Fig. 2-3; flange 30 is intended to be squeezed together with flange 12 which implies the use of fingers in one hand operation, see Col 1 lines 22-23), the flange being annular such that the flange encircles the barrel (flange 30 is annular and encircles cylinder 10, Fig. 1-2), and the aspiration mechanism configured for withdrawing the plunger from the barrel as the finger-support member is slid over the barrel toward the thumb-support member (see Col 2 lines 33-35 & Fig. 3).
Regarding claim 36, Tartaglia discloses all the limitations of claim 34. Tartaglia further discloses the aspiration syringe wherein the flange is configured to accommodate a pair of finger pads of a pair of fingers (via the invention being “a medical syringe adapted for one hand operation in both aspiration and injection modes,” Col 1 lines 22-23; the flange intended for one hand operation with fingers) placed against a distal side thereof in any chosen placement of each finger of the pair of fingers around the flange (lines 52 of Fig. 3 depict how the squeezing is to occur for aspiration to ensue; considering single hand operation, fingers could be placed on the distal side of flange 30 and used to squeeze flange 30 towards first flange 12, Col 2 lines 33-35).
Regarding claim 38, Tartaglia discloses all the limitations of claim 34. Tartaglia further discloses the aspiration syringe wherein the proximal annular member is configured to accommodate a thumbpad of a thumb placed against a proximal side thereof in any chosen placement of the thumb around the proximal annular member (lines 52 of Fig. 3 depict how the squeezing is to occur for aspiration to ensue; considering single hand operation, a thumb could be placed on a proximal side of flange 12 and used to squeeze flange 12 towards second flange 30, Col 2 lines 33-35).
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 35 is rejected under 35 U.S.C. 103 as being unpatentable over Tartaglia (US 4484915 A).
Regarding claim 35, Tartaglia discloses all the limitations of claim 34. However, Tartaglia does not explicitly disclose the syringe housing and the plunger molded together in an integral piece such that the proximal portion of the syringe housing is integral with the proximal portion of the plunger.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the syringe housing and plunger to be molded together in an integral piece since it has been held “that the use of a one-piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice." In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). The device of Tartaglia, upon assembly, would function as intended and be structurally the same as the claimed device if the proximal portions of elements 32 were molded together in an integral piece with head 28.
Additionally, the Examiner notes that the claim limitation can be considered as a product-by-process limitation. Patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, MPEP 2113. Further, it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. (Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Claims 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Tartaglia (US 4484915 A), in view of Fransson (US 20170028135 A1).
Regarding claim 37, Tartaglia discloses all the limitations of claim 36. However, Tartaglia fails to explicitly discloses the aspiration syringe wherein the flange includes an annular finger recess in a distal face thereof, the annular finger recess configured to cradle the pair of finger pads of the pair of fingers. However, Fransson teaches the aspiration syringe wherein the flange includes an annular finger recess in a distal face thereof (finger grip enhancing means 11, 12, and 13, [0043] & Fig. 4a; the annular ribs spaced from one another create annular recesses), the annular finger recess configured to cradle the pair of finger pads of the pair of fingers (the finger grip enhancing means create annular recesses on the plunger rod which “provide a user with reliable grip during manipulation,” [0043] & Fig. 4a).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the aspiration syringe of Tartaglia with Fransson to include the annular finger recess since such a modification would provide structure to aid in the manipulation and control of the distal annular member. The modification provides predictable results pertaining to reliable device control during use, [0043] of Fransson. As combined, an annular recess, like the one created between grip enhancing means 11 and 12 of Fransson, would be provided around the entire distal face of flange 30 of Tartaglia. The combination is suitable since flange 30 of Tartaglia is intended to hold and function with fingers, like the grip enhancing means 11 and 12 of Fransson.
Regarding claim 39, Tartaglia discloses all the limitations of claim 38. However, Tartaglia fails to explicitly discloses the aspiration syringe wherein the proximal annular member includes an annular thumb recess in a proximal face thereof, the annular thumb recess configured to cradle the thumbpad of the thumb. However, Fransson teaches the aspiration syringe wherein the proximal annular member includes an annular thumb recess in a proximal face thereof (finger grip enhancing means 11, 12, and 13, [0043] & Fig. 4a; the annular ribs spaced from one another creating an annular recess), the annular thumb recess configured to cradle the thumbpad of the thumb (the finger (a thumb is disclosed as a finger in [0047]) grip enhancing means creates an annular recess on the plunger rod which “provide[s] a user with reliable grip during manipulation,” [0043] & Fig. 4a).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the aspiration syringe of Tartaglia with Fransson to include the annular thumb recess since such a modification would provide structure to aid in the manipulation and control of the proximal annular member. The modification provides predictable results pertaining to reliable device control during use, [0043] of Fransson. As combined, an annular recess, like the one created between grip enhancing means 11 and 12 of Fransson, would be provided around the entire proximal face of flange 12 of Tartaglia. The combination is suitable since flange 12 of Tartaglia is intended to hold and function with a thumb, like the grip enhancing means 11 and 12 of Fransson.
Claims 1, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US 20180008294 A1), in view of Reitz-Lennemann (DE 202012006191 U1).
Regarding claim 1, Garrison discloses an aspiration syringe (aspiration device, abstract), comprising: a barrel (barrel 120, [0040] & Fig. 1); a plunger disposed in the barrel (plunger 125, [0040] & Fig. 1; “is sized and shaped to slide within the barrel”); and an aspiration mechanism including: a thumb-support member bonded to a proximal portion of the barrel (one or more tabs 310, [0041] & Fig. 1-3; “attached to a proximal region of the main syringe barrel” [0041]; tabs 310 are being interpreted as bonded to the barrel since they are attached to one another) the thumb-support member configured to encourage approximately longitudinal alignment of a thumb with a surface normal of a surface of the barrel (tab 310, with the depicted recess, is capable of meeting the function of cradling a thumbpad of a thumb, as is seen in Figure 3, while encouraging approximately longitudinal alignment of the thumb; the user may position their thumb in the recess of tab 310 in the same orientation as is seen on the plunger 125 of Fig. 4); and
a syringe housing disposed around the barrel (outer syringe barrel 130, [0040] & Fig. 1; “the syringe plunger 125 and outer syringe barrel 130 collectively form a body that is slidably coupled to the main syringe barrel 120 such that they can slide relative to the main syringe barrel 120” [0040]) but for a single longitudinal gap within which the thumb-support member moves relative to the syringe housing when the syringe housing is slid over the barrel (via “the index/middle fingers and thumb are then squeezed together to move the tabs 305 and 310 toward one another, which causes the plunger 125 to move in a proximal direction relative to the inside of the main barrel chamber,” [0041] & Fig. 1 and 3; the outer syringe barrel 130 contains a single longitudinal gap which allows for the tabs 310 to slide relative to the outer syringe barrel 130; outer syringe barrel 130 is disposed around barrel 120 except for the single longitudinal gap), the syringe housing including a proximal portion coupled to a proximal portion of the plunger (via “an outer syringe barrel 130 is attached to the syringe plunger 125 such as via adhesive,” [0040] & Fig. 1) and a distal portion terminating with a flange (via “one or more tabs 305 that are attached to a distal region of the outer syringe barrel 130,” [0041] & Fig. 1) incorporated into a finger-support member (via “to aspirate fluid into the chamber, a user positions his or her fingers on a distal side of the tabs 305 such as with the index and middle fingers,” [0041] & Fig. 1 and 3), the flange configured to encourage placement of each finger of a pair of fingers on an opposite side of the barrel (tabs 305, with their depicted recesses, are configured to encourage placement of each finger of a pair of fingers on an opposite side of the barrel, [0042] & Fig. 3), and
the aspiration mechanism configured for withdrawing the plunger from the barrel as the finger-support member is slid over the barrel toward the thumb-support member (via “the index/middle fingers and thumb are then squeezed together to move the tabs 305 and 310 toward one another, which causes the plunger 125 to move in a proximal direction relative to the inside of the main barrel chamber,” [0041] & Fig. 1 and 3).
However, Garrison fails to explicitly disclose the aspiration syringe wherein the syringe housing and the plunger are molded together in an integral piece such that the proximal portion of the syringe housing is integral with the proximal portion of the plunger.
However, Reitz-Lennemann, hereafter referred to as Reitz, teaches the aspiration syringe wherein the syringe housing (thrust device 32, abstract) and the plunger (piston rod 18, abstract) are molded together in an integral piece such that the proximal portion of the syringe housing is integral with the proximal portion of the plunger (via “a... embodiment of the syringe is possible if the thrust device is designed in one piece with the piston rod. ...piston rod and piston handle are often formed in one piece, the thrust device can be formed directly in this case,” [0017] & Fig. 1). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the aspiration syringe of Garrison with Reitz to include the syringe housing and plunger molded together in an integral piece since such a modification would make the plunger and syringe housing easily usable with commercially available components, like the barrel. This modification provides predictable results pertaining to straight forward commercial integration of the claimed invention ([0017).
Additionally, the limitation of “a thumb-support member bonded to a proximal portion of the barrel” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art, MPEP 2113. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, MPEP 2113. Further, it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. (Howard v. Detroit Stove Works, 150 U.S. 164 (1893). In the instant case, the claimed thumb-support member is structurally the same as the tabs 310 of Garrison considering the tabs are attached to the barrel and functionally capable of holding a thumb.
Regarding claim 5, Garrison, as modified, discloses all the limitations of claim 1. Garrison further discloses the aspiration syringe wherein the flange includes a pair of finger recesses in a distal face of the flange (annotated Figure 2 below depicts a pair of finger recesses on a distal face of tabs 305; the arrows in reference to “Finger” denoting the pair of recesses) configured to respectively cradle a pair of finger pads of the pair of fingers, the pair of finger recesses encouraging the placement of each finger of the pair of fingers on the opposite side of the barrel (Figure 3 depicting a pair of finger pads of a pair of fingers cradled in the finger recesses on opposite sides of the barrel).
PNG
media_image1.png
539
747
media_image1.png
Greyscale
Regarding claim 8, Garrison, as modified, discloses all the limitations of claim 1. Garrison further disclose the aspiration syringe wherein the thumb-support member includes a single thumb recess in a proximal face of the thumb-support member (annotated Figure 2 above depicts a thumb recess in a proximal face of tab 310; the arrow in reference to “Thumb” denoting the thumb recess) configured to cradle a thumbpad of the thumb, the single thumb recess encouraging the approximately longitudinal alignment of the thumb with the surface normal of the surface of the barrel (the tab 310, with the depicted recess, is capable of meeting the function of cradling a thumbpad of a thumb, as is seen in Figure 3, while encouraging approximately longitudinal alignment of the thumb; the user may position their thumb in the recess of tab 310 in the same orientation as is seen on the plunger 125 of Fig. 4).
Response to Arguments
Applicant's arguments filed January 7th 2025 have been fully considered but they are not persuasive. In response to Applicant’s arguments that the two oppositely disposed axially extending members or elements 32 do not correspond to the syringe housing of amended claim 34, the Examiner finds that elements 32 are disposed around cylinder 10 and elements 32 are spaced apart, which creates a single longitudinal gap formed through the syringe housing. The gap in elements 32 allows flange 12 to slide with respect to flange 30. Elements 32 and flange 30 are disposed all around cylinder 10 except for the single longitudinal gap.
In response to Applicant’s arguments that barrel 130 does not correspond to the syringe housing of amended claim 1, the Examiner finds that barrel 130 is disposed around barrel 120 and contains a single longitudinal gap, formed through barrel 130, which allows for the tabs 310 to slide. Outer syringe barrel 130 is disposed all around barrel 120 except for the single longitudinal gap.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schweblin (US-4639248-A). Schweblin teaches a bearing surface 5 configured to hold a thumb and a semi-cylindrical outer portion 10 that is disposed around body 1 but for a single longitudinal gap in which substantially semi-circular plate 5 slides (Col 3 lines 15-26, Col 3 last paragraph - Col 4 first paragraph, and Col 4 lines 8-27 & Fig. 1-6)
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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.
/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783