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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 December 2025 has been entered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-7 and 17-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-7 of U.S. Patent No. 11,179,520 in view of U.S. Patent No. 4,950,265 (“Taylor”) and U.S. Patent No. 8,240,511 (“Greter”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent anticipate the instant claims.
Regarding Claims 1 and 17, the reference patent Claim 1 recites, inter alia, an aspirating syringe having a distal end for insertion into a cavity and a proximal end operable by a user comprising:
a syringe barrel having a distal end couplable to a needle and an open proximal end;
a plunger seal disposed inside the syringe barrel;
a plunger rod disposed in the syringe barrel extending along a longitudinal axis between a first end coupled to the plunger seal and a second end opposite of the first end;
a plunger extension coupled to the second end of the plunger rod moving in unison with the plunger rod, the plunger extension extending longitudinally from the second end of the plunger rod;
a compressible handle having a plurality of components, the plurality of components forming a first linked handle and a second linked handle disposed symmetrically in diametrical opposition about the barrel and the plunger rod;
the first linked handle having a first handle and a second handle, the first handle having a first length and the second handle having a second length different from the first length, the first handle having a proximal end flexibly coupled to the plunger extension and a distal end flexibly coupled to a proximal end of the second handle, and the second handle having a distal end flexibly coupled to a portion of the syringe barrel;
the second linked handle having a first handle and a second handle, the first handle having a first length and the second handle having a second length different from the first length, the first handle having a proximal end flexibly coupled to the plunger extension and a distal end flexibly coupled to a proximal end of the second handle, and the second handle having a distal end flexibly coupled to a portion of the syringe barrel;
wherein compressing the compressible handle causes the handle to longitudinally extend and causes the syringe plunger to move rearwardly in the syringe barrel away from the needle.
Further divergence may be considered where the instant application claims recite a “flange” associated with the proximal end of the plunger distinctive from the extension, whereas the reference patent fails to recite such a flange. However, Taylor discloses a related syringe (Fig. 5) wherein the syringe (604) is an otherwise standard manual syringe receivable within the aspiration device, the syringe having a proximal thumb flange to allow manipulation of the plunger directly by a user. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the plunger of reference patent with a thumb flange, distinctive from the extension, so that the syringe can be used independently by direct engagement by the user based on user preference for whether or not to use the aspiration assistance system.
New limitations directed toward “the syringe barrel extending continuously from the distal end to the open proximal end as a unitary wall” is not found to be distinguishing over consideration of the standard and typical arrangement for a syringe barrel (see e.g. 3B, 3B – Greter), such that constructing the generically recited syringe barrel of the reference patent to extend continuously from the distal delivery end to the open proximal, piston receiving end would have been obvious to provide a standard, typical, and well-known construction. Furthermore, even in consideration of Taylor (See Fig. 4) wherein the syringe is formed as two separate components, e.g. a syringe reservoir (64) and mounting sleeve (66), integrating the mounting hardware of the sleeve to the syringe reservoir itself as a integral, unitary construction would have been obvious, inasmuch as it has been found that constructing, in one-piece, a structure which was formerly constructed as a plurality of separate components to be affixed together, an obvious design choice, when only predictable and expected results are achieved see In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Such a modification would present with a syringe barrel which is clearly unitary and “continuous” in its extension.
The additional limitations of the compressible handle defining the aspirated volume of fluid, wherein the maximum compressible distance of the handle relative to the syringe barrel defines the maximum aspirated volume of the syringe derives directly form the claim limitation of the reference patent that “compressing the compressible handle causes the handle to longitudinally extend and causes the syringe plunger to move rearwardly in the syringe barrel away from the needle”. Since the stroke length (and aspiration volume) of the syringe is a product of compression of the handle, then the maximum compression of the handle will be understood to define a corresponding volume of the syringe which constitutes the maximum volume which can be aspirated pursuant to the maximal operation of the compressible handle.
Claims 4-7, 18, 20-23, 25-26 present features either expressly reflected in the claims (see also Claims 2-8) or nominally different claim language which fails to reflect a different scope.
Regarding Claims 9, 12-16, and 24, these claims differ inasmuch as they require the handle components to be of “equal length”. However, Greter (see in greater detail below as applied to suggest obvious modifications to Taylor), obviates the use of segments of equal length whereby such a change in shape is obvious, as it is known to the prior art to provide expected and predictable results, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), and therefore fails to define and distinguish the claims of the reference patent over the prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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) 22, 24, and 25 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention OR 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 Claim 22, 24, and 25, Applicant recites the limitations “the first handles are responsible to a force applied thereto to displace the needle, the force being substantially parallel to the longitudinal axis”.
Firstly, Examiner notes that the instant specification presents no standard for establishing a “substantially” parallel direction of force with respect to the longitudinal axis. As such, it is unclear how much deviation can or cannot occur before a direction is no longer “substantially” parallel to the longitudinal axis. Presuming that the intent of the instant limitation was intended to be supported by the “pressure” applied to the handles (e.g. 78 – see Par. 96) the direction of this pressure is only shown in the same direction of the longitudinal axis with no apparent deviation.
Based on the disclosure, it is unclear if non-longitudinally applied forces could even advance or drive the needle into tissue without incidental actuation of the extension since any non-longitudinal force will necessarily have both and X and Y component wherein the X component will act on the handles in the same direction as arrow (79). As such, the specification only establishes that Applicant was in possession of an invention wherein the combined friction forces between the piston and syringe barrel along with the exemplary shapes of the handles allows a user to provide a sufficient pressure on the handles to insert the syringe needle without activating the plunger extension when supplied to a pressure “in the direction of the arrows 78” (i.e. longitudinal versus “substantially” longitudinal). While frictional forces between the piston and syringe barrel wall COULD be further modified to make them more resistant to movement there is no consideration that Applicant contemplated doing so pursuant to anything other than a longitudinally applied force (78).
Secondly, the phrase “responsible to a force” appears to be a grammatic error, perhaps intended to read “responsive to a force”, but since this phrasing for this limitation, in general, is not found in the specification it is impossible to determine Applicant’s intent here.
Thirdly, the phrase “displace the needle” is never used in the specification and it is unclear if those scope of “displace” is the same or different from the phrase “advance the syringe… and drive a needle through bodily tissue” used in the specification. For example, it is unclear if the broadest reasonable interpretation of “displace the needle” would or would not cover non-penetrative movement. While the claims are interpreted in light of the specification it is important not to impart limitations from the specification into the claims and any deviation between the language of the claims and the specification, must be presumed to present claims that seek to deviate from the express scope of the specification. Here the claimed relationship varies conspicuously from that language used in the specification where “displace the needle” is certainly MUCH broader than “advance the syringe… and drive a needle through bodily tissue… without activating the plunger extension”.
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) 1, 5, 6, 17, 18, 22, 23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,950,265 (“Taylor”) in view of U.S. Patent No. 4,624,659 (“Goldberg”).
Regarding Claims 1, 17, 18, and 23, Taylor discloses an aspirating (RE: “biopsy”) syringe (generally 64) having a distal end (see generally 95 – consider specifically the needle, not shown, to be affixed to 95) for insertion into a cavity and a proximal end (see generally 84) operable by a user comprising:
a syringe barrel (90) having a distal end (95) couplable to a needle and an open proximal end (at 108 – specifically when the piston/plunger is removed);
in the instant case Examiner submits that when the syringe barrel is considered to be the syringe reservoir (90) of Taylor, per se, without consideration of the sleeve (66) it may be clearly understood that a wall of the syringe barrel extends continuously from the distal end to the open proximal end as a unitary wall (see generally Fig. 7 which clearly illustrates the unitary construction of the syringe wall (90) of the syringe reservoir/barrel (90);
a plunger seal (i.e. the distal end of plunger 88 received within the syringe barrel) disposed inside the syringe barrel;
a plunger rod (i.e. the intermediate portion of 88) disposed in the syringe barrel extending along a longitudinal axis between a first end coupled to the plunger seal and a second end opposite of the first end;
a flange (i.e. the thumb flange carried by the proximal end of the plunger rod – see Fig. 4) coupled to the second end of the plunger rod;
a compressible handle (60) comprising a plurality of handle components (re: the right and left hand sides) disposed symmetrically in diametrical opposition about the barrel and the plunger rod (see Fig. 5), wherein compressing the compressible handle causes the handle to longitudinally extend and causes the syringe plunger to move rearwardly in the syringe barrel away from the needle (see generally Fig. 6 – compare solid to phantom).
In use, it must be understood that the compressible handle is arranged relative to the syringe barrel to define an aspirated volume of fluid to extract since compression of the handle is responsible for defining the stroke length of the piston/plunger (see generally Fig. 2 and 6 – compare the position of the handle and piston/plunger in solid versus in phantom; see also generally Col. 4, Ln. 36-43 – re: “the user’s fingers 30 will compress or squeeze the arcuate member 112 [corresponding to the handle 60 in Fig. 4/5] against the sleeve 114 to deform the member 112, thereby extending the plunger 88 outwardly from the syringe barrel 90, and maintaining such extension during removal of the syringe 64 from the point of aspiration biopsy.” Because the piston stroke length (and therefore aspiration volume) is correlated with the displacement of the handle it is submitted that a maximum aspirated volume of the syringe correlates to the maximum compressible distance of the handle which creates the maximum possible displacement of the piston which corresponds to the aspirated volume.
Taylor discloses the invention substantially as claimed except that that the compressible handle comprises “a plurality of components” in the embodiment paired with the syringe (64) – while Taylor does disclose a multi-component handle (150) in other embodiments (see Fig. 9 and 10) such a configuration is not expressly paired with the aspiration syringe (64). However, given the similarities of shapes between handle (60) and (10) Examiner submits that the ordinary artisan would have reasonably recognized and appreciate that the shape of the handle (60) is merely exemplary, not exhaustive, and the shape of the handle (60) could reasonably be altered to other known, useful shapes (see e.g. 150) with expected and predictable results. It has been held that selecting a known shape for a known construction is an obvious design choice requiring only routine and customary knowledge where only predictable results are expected, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
In performing such a modification the handle of modified Taylor will comprise a plurality of components (see the plurality of segments forming 160, 162), the plurality of components forming a first linked handle (162) and a second linked handle (160) disposed symmetrically in diametrical opposition about the barrel and the plunger rod (see generally Fig. 9 as it applies to modification to Fig. 5);
the first linked handle having a first handle (see e.g. the first segment of 160) and a second handle (see e.g. the second segment of 160), the first handle having a first length and the second handle having a second length different from the first length (i.e. the first handle can comprise either the first segment alone OR the first two segments and the second handle can, respectively, comprise either the second two segments OR the third segment), the first handle having a proximal end (see generally 158, 154; see also 70, 80, 82) flexibly coupled to the plunger flange (see where the proximal end of the handle abuts against the flange) and a distal end flexibly coupled to a proximal end of the second handle (i.e. the handles are joined at a segmented joint – see Fig. 10) and the second handle having a distal end (see generally 152, 156; see also 72, 76) flexibly coupled to a portion of the syringe barrel (wherein it is submitted that “coupled” is permissive to indirect couplings provided via the carrier sleeve 66 and does not necessarily denote direct coupling – note Claim 4 which further specifies “directly coupled” which implies that “coupled” is broader than “directly coupled”);
the second linked handle having a first handle and a second handle, the first handle having a first length and the second handle having a second length different from the first length, the first handle having a proximal end flexibly coupled to the plunger flange and a distal end flexibly coupled to a proximal end of the second handle, and the second handle having a distal end flexibly coupled to a portion of the syringe barrel (see generally Fig. 10 as it applies to modification of Fig. 5). Again, it is reiterated that it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the handle of the invention of Taylor (Fig. 5) as a pair of linked handles comprising respective first and second handle segments, as illustrated in association with the embodiment of Fig. 10 of Taylor, as a mere obvious design choice pursuant to using a shape identified in the prior art to be known, useful, and predictable in causing a withdrawal motion of a piston implement of an aspirating device. It has been held that such mere changes in shape are obvious when affecting or predictable and expected results, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Here, Taylor establishes the linked handle configuration (See Fig. 9 and 10) to be a direct, suitable alternative to a generally circular handle configuration (See particularly Fig. 2 and 3 and consider the shared shape of the handles in Fig. 3 and Fig. 4).
Taylor, as modified, discloses the invention substantially as claimed except that the syringe further comprises a plunger extension coupled to the flange of the plunger rod moving in unison with the plunger rod, the plunger extension extending longitudinally from the flange. However, Goldberg discloses a related biopsy/aspiration syringe (Fig. 2) which comprises a plunger rod (20) having an extension (36, 38) coupled to the flange of the plunger rod and moving in unison therewith (i.e. the two components are formed together and therefore move together), the plunger extension extending longitudinally from the flange the plunger rod (see Fig. 4, see also alternative embodiment 7). Goldberg discloses that this extension serves as a visual and tactile aide in assisting a user to determine a pressure change incident to penetration of a fluid filled space (Abstract; Background). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the flange of Taylor with the plunger extension provided extending proximally therefrom, as disclosed by Goldberg, such that a user can place their thumb at the extension and confirm/sense a pressure change incident to penetration of the syringe into a fluid filled space thereby improving accuracy of the aspiration/biopsy.
In constructing such a flange and extension in modified Taylor the first handle will be understood to be coupled to the plunger extension (via the intermediary of the flange) in the same manner that Applicant’s handles are coupled to the extension (see Figs. 7A-7C).
Regarding Claims 5 and 6, Taylor, as modified by Goldberg, provides for a plunger extension which stabilizes the syringe in a hand of the user – i.e. the plunger extension serves as a thumb apposition surface whereby the user may use the enlarged surface area to support the device via various handgrip positions, thereby improving balance and center of gravity for the syringe.
Regarding Claims 22 and 25, in Taylor, the first handles are responsive to a force applied thereto to displace the needle (i.e. the syringe can be gripped at the first handles and moved to position the needle in ANY desired direction inclusive, but not limited to, displacing the needle in a direction parallel to the longitudinal axis, where it is understood that direction of displacement is in the same direction as the applied force – see Newton’s Laws of Motion). This displacement can occur before, during, or after an injection has occurred.
Claim(s) 4 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,950,265 (“Taylor”) in view of U.S. Patent No. 4,624,659 (“Goldberg”) as applied above, and further in view of U.S. Patent No. 6,030,368 (“Anwar”).
Regarding Claims 4 and 26, Taylor, as modified, discloses the invention substantially as claimed except that distal end of the second handles are “directly” coupled to the portion of the syringe barrel. Rather Taylor relies upon a mounting sleeve/carrier (66) to adapt the geometry of the syringe barrel (90) to couple the handles to the syringe barrel (see at 98). However, Anwar discloses a related syringe (50) which is actuated by a handle (70, 60) mounted to the syringe plunger rod (at 95) and the syringe barrel (at 87), wherein Anwar discloses that the adapter (87) for mount the handle to the syringe barrel is “preferably… formed integral with the reservoir” (Col. 6, Ln. 15-16). As such, it would have been obvious to construct the mounting groove (98) of Taylor to be unitarily integral with the barrel (and not provided as a separate sleeve), as disclosed by Anwar, whereby Anwar establishes that such an integral construction is “preferable”, thereby eliminating the need for a separate carrier, thereby only achieving the expected and predictable outcome of constructing, in one-piece, a structure which was formerly constructed as a plurality of separate components to be affixed together, an obvious design choice, see In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Creation of such a proprietary construction, as opposed to serving as an adapter for a common syringe, could be made for a number of economic considerations (i.e. being able to command a higher price point), ensuring interoperability (by controlling for any variances in syringe manufacturing), or to prevent misuse of the product (i.e. preventing a used biopsy syringe from being reused to perform an injection of a different substance).
Claim(s) 7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,950,265 (“Taylor”) in view of U.S. Patent No. 4,624,659 (“Goldberg”) as applied above, and further in view of U.S. Patent No. 5,607,399 (“Grimard”).
Regarding Claims 7 and 20, Taylor discloses the invention substantially as claimed except that that the invention comprises a “limiter” limit movement of the compressible handle to the maximum compressible distance. However, Gimard discloses a syringe (Fig. 1) which includes a limiter (55) which corresponds to a maximum stroke length of the piston/plunger to prevent accidental withdrawal of the plunger/piston from the syringe barrel (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to place a limiter in the invention of Taylor corresponding to the maximum stroke length of the piston (which therefore corresponds to the maximum compressible distance of the handles since it is the handles which define the piston stroke length), as disclosed by Grimard, in order to prevent the piston from being accidentally displaced from the piston rod when the handles are fully compressed. Again, based on the correlation between piston displacement and handle compression in Taylor, it will; be understood that the limiter of modified Taylor effectively stops any further compression of the handles because the limiter will stop rearward displacement of the plunger and so no further compression will be possible.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,950,265 (“Taylor”) in view of U.S. Patent No. 4,624,659 (“Goldberg”) as applied above, and further in view of U.S. Patent No. 8,240,511 (“Greter”).
Regarding Claim 21, Taylor discloses the invention substantially as claimed except that that the first handle(s) and the second handle(s) comprise segments of “equal length” – specifically consideration of the first and second segments of Taylor to comprise respective distal and proximal ends adjoined to one another, as claimed, requires the segments to be unequal in length due to the hexagonal arrangement of the handles/arms. However, the prior art – see Greter – discloses a similar handle arrangement (see e.g. Fig. 7) configured to create a slaved relationship between the syringe barrel and the syringe plunger (see Fig. 6), whereby instead of a hexagonal arrangement like that employed by Taylor with the handles being composed of a total of three hinged segments, Greter discloses that each handle may be constructed as only two hinged segments of equal length (see Fig. 7). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the handles of the invention of Taylor to comprise exactly two segments of equal length, as disclosed by Greter, whereby such a shape is considered to be an obvious design choice which will affect only predictable and expected results and constitutes an obvious variant of the unsegmented handle arrangement (60) and the three segmented variant (150), whereby such changes in shape, particularly when known to the art, are obvious for effecting only expected and predictable results, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 9, 13, 14, 16, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,950,265 (“Taylor”) in view of U.S. Patent No. 8,240,511 (“Greter”) and U.S. Patent No. 4.624.659 (“Goldberg”).
Regarding Claim 9, Taylor discloses an aspirating (RE: “biopsy”) syringe (generally 64) having a distal end (see generally 95 – consider specifically the needle, not shown, to be affixed to 95) for insertion into a cavity and a proximal end (see generally 84) operable by a user comprising:
a syringe barrel (90) having a distal end (95) couplable to a needle and an open proximal end (at 104 – specifically when the piston/plunger is removed);
in the instant case Examiner submits that when the syringe barrel is considered to be the syringe reservoir (90) of Taylor, per se, without consideration of the sleeve (66) it may be clearly understood that a wall of the syringe barrel extends continuously from the distal end to the open proximal end as a unitary wall (see generally Fig. 7 which clearly illustrates the unitary construction of the syringe wall (90) of the syringe reservoir/barrel (90);
a plunger seal (i.e. the distal end of plunger 88 received within the syringe barrel) disposed inside the syringe barrel;
a plunger rod (i.e. the intermediate portion of 88) disposed in the syringe barrel extending along a longitudinal axis between a first end coupled to the plunger seal and a second end opposite of the first end;
a flange (i.e. the thumb flange carried by the proximal end of the plunger rod – see Fig. 4) coupled to the second end of the plunger rod;
a compressible handle (60) having a plurality of components (i.e. the left and right hand sides) disposed symmetrically about the barrel and plunger rod in diametrical oppositon, wherein compressing the compressible handle causes the handle to longitudinally extend and causes the syringe plunger to move rearwardly in the syringe barrel away from the needle (see generally Fig. 2 and 6 – compare solid to phantom with the understanding that compression of the circular handle 60 in Fig. 4, 5 will produce an equivalent relationship).
In use, it must be understood that the compressible handle is arranged relative to the syringe barrel to define an aspirated volume of fluid to extract since compression of the handle is responsible for defining the stroke length of the piston/plunger (see generally Fig. 2 and 6 – compare the position of the handle and piston/plunger in solid versus in phantom; see also generally Col. 4, Ln. 36-43 – re: “the user’s fingers 30 will compress or squeeze the arcuate member 112 [corresponding to the handle 60 in Fig. 4/5] against the sleeve 114 to deform the member 112, thereby extending the plunger 88 outwardly from the syringe barrel 90, and maintaining such extension during removal of the syringe 64 from the point of aspiration biopsy.” Because the piston stroke length (and therefore aspiration volume) is correlated with the displacement of the handle it is submitted that a maximum aspirated volume of the syringe correlates to the maximum compressible distance of the handle which creates the maximum possible displacement of the piston which corresponds to the aspirated volume.
Taylor discloses the invention substantially as claimed except that that the compressible handle comprises “a plurality of components” in the embodiment paired with the syringe (64) – while Taylor does disclose a multi-component handle (150) in other embodiments (see Fig. 9 and 10) such a configuration is not expressly paired with the aspiration syringe (64). However, given the similarities of shapes between handle (60) and (10) Examiner submits that the ordinary artisan would have reasonably recognized and appreciate that the shape of the handle (60) is merely exemplary, not exhaustive, and the shape of the handle (60) could reasonably be altered to other known, useful shapes (see e.g. 150) with expected and predictable results. It has been held that selecting a known shape for a known construction is an obvious design choice requiring only routine and customary knowledge where only predictable results are expected, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
In performing such a modification the handle of modified Taylor will comprise a plurality of components (see the plurality of segments forming 160, 162), the plurality of components forming a first linked handle (162) and a second linked handle (160) disposed symmetrically in diametrical opposition about the barrel and the plunger rod (see generally Fig. 9 as it applies to modification to Fig. 5);
the first linked handle having a first handle (see e.g. the first segment of 160) and a second handle (see e.g. the second segment of 160), the first handle having a proximal end (see generally 158, 154; see also 70, 80, 82) flexibly coupled to the plunger flange (see where the proximal end of the handle abuts against the flange) and a distal end flexibly coupled to a proximal end of the second handle (i.e. the handles are joined at a segmented joint – see Fig. 10) and the second handle having a distal end (see generally 152, 156; see also 72, 76) flexibly coupled to a portion of the syringe barrel (whereby flexibly coupled is understood to be permissive of indirect coupling such as use of the sleeve (66) in Taylor);
the second linked handle having a first handle and a second handle, the first handle having a proximal end flexibly coupled to the plunger flange and a distal end flexibly coupled to a proximal end of the second handle, and the second handle having a distal end flexibly coupled to a portion of the syringe barrel (see generally Fig. 10 as it applies to modification of Fig. 5). Again, it is reiterated that it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the handle of the invention of Taylor (Fig. 5) as a pair of linked handles comprising respective first and second handle segments, as illustrated in association with the embodiment of Fig. 10 of Taylor, as a mere obvious design choice pursuant to using a shape identified in the prior art to be known, useful, and predictable in causing a withdrawal motion of a piston implement of an aspirating device.
Taylor discloses the invention substantially as claimed except that that the first handle(s) and the second handle(s) comprise segments of “equal length” – specifically consideration of the first and second segments of Taylor to comprise respective distal and proximal ends adjoined to one another, as claimed, requires the segments to be unequal in length due to the hexagonal arrangement of the handles/arms. However, the prior art – see Greter – discloses a similar handle arrangement (see e.g. Fig. 7) configured to create a slaved relationship between the syringe barrel and the syringe plunger (see Fig. 6), whereby instead of a hexagonal arrangement like that employed by Taylor with the handles being composed of a total of three hinged segments, Greter discloses that each handle may be constructed as only two hinged segments of equal length (see Fig. 7). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the handles of the invention of Taylor to comprise exactly two segments of equal length, as disclosed by Greter, whereby such a shape is considered to be an obvious design choice which will affect only predictable and expected results and constitutes an obvious variant of the unsegmented handle arrangement (60) and the three segmented variant (150), whereby such changes in shape, particularly when known to the art, are obvious for effecting only expected and predictable results, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Taylor, as modified, discloses the invention substantially as claimed except that the syringe further comprises a plunger extension coupled to the flange of the plunger rod moving in unison with the plunger rod, the plunger extension extending longitudinally from the flange. However, Goldberg discloses a related biopsy/aspiration syringe (Fig. 2) which comprises a plunger rod (20) having an extension (36, 38) coupled to the flange of the plunger rod and moving in unison therewith (i.e. the two components are formed together and therefore move together), the plunger extension extending longitudinally from the flange the plunger rod (see Fig. 4, see also alternative embodiment 7). Goldberg discloses that this extension serves as a visual and tactile aide in assisting a user to determine a pressure change incident to penetration of a fluid filled space (Abstract; Background). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the flange of Taylor with the plunger extension provided extending proximally therefrom, as disclosed by Goldberg, such that a user can place their thumb at the extension and confirm/sense a pressure change incident to penetration of the syringe into a fluid filled space thereby improving accuracy of the aspiration/biopsy.
In constructing such a flange and extension in modified Taylor the first handle will be understood to be coupled to the plunger extension (via the intermediary of the flange) in the same manner that Applicant’s handles are coupled to the extension (see Figs. 7A-7C).
Regarding Claims 13 and 14, Taylor, as modified see Goldberg, provides for a plunger extension which stabilizes the syringe in a hand of the user – i.e. the plunger extension serves as a thumb apposition surface whereby the user may use the enlarged surface area to support the device via various handgrip positions, thereby improving balance and center of gravity for the syringe.
Regarding Claim 16, Taylor, as modified, discloses the plunger extension extends longitudinally along the longitudinal axis of the plunger rod (i.e. the longitudinal extent of the plunger).
Regarding Claim 24, in Taylor, the first handles are responsive to a force applied thereto to displace the needle (i.e. the syringe can be held at the first handles and moved to position the needle in ANY desired direction inclusive, but not limited to, displacing the needle in a direction parallel to the longitudinal axis, where it is understood that direction of displacement is in the same direction as the applied force – see Newton’s Laws of Motion). This displacement can occur before, during, or after an injection has occurred.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,950,265 (“Taylor”) in view of U.S. Patent No. 8,240,511 (“Greter”) and U.S. Patent No. 4.624.659 (“Goldberg”) as applied above, and further in view of U.S. Patent No. 6,030,368 (“Anwar”).
Regarding Claim 12, Taylor, as modified, discloses the invention substantially as claimed except that distal end of the second handles are “directly” coupled to the portion of the syringe barrel. Rather Taylor relies upon a mounting sleeve/carrier (66) to adapt the geometry of the syringe barrel (90) to couple the handles to the syringe barrel (see at 98). However, Anwar discloses a related syringe (50) which is actuated by a handle (70, 60) mounted to the syringe plunger rod (at 95) and the syringe barrel (at 87), wherein Anwar discloses that the adapter (87) for mount the handle to the syringe barrel is “preferably… formed integral with the reservoir” (Col. 6, Ln. 15-16). As such, it would have been obvious to construct the mounting groove (98) of Taylor to be unitarily integral with the barrel (and not provided as a separate sleeve), as disclosed by Anwar, whereby Anwar establishes that such an integral construction is “preferable”, thereby eliminating the need for a separate carrier, thereby only achieving the expected and predictable outcome of constructing, in one-piece, a structure which was formerly constructed as a plurality of separate components to be affixed together, an obvious design choice, see In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Creation of such a proprietary construction, as opposed to serving as an adapter for a common syringe, could be made for a number of economic considerations (i.e. being able to command a higher price point), ensuring interoperability (by controlling for any variances in syringe manufacturing), or to prevent misuse of the product (i.e. preventing a used biopsy syringe from being reused to perform an injection of a different substance).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,950,265 (“Taylor”) in view of U.S. Patent No. 8,240,511 (“Greter”) and U.S. Patent No. 4.624.659 (“Goldberg”) as applied above, and further in view of U.S. Patent No. 5,607,399 (“Grimard”).
Regarding Claim 15, Taylor discloses the invention substantially as claimed except that that the invention comprises a “limiter” limit movement of the compressible handle to the maximum compressible distance. However, Gimard discloses a syringe (Fig. 1) which includes a limiter (55) which corresponds to a maximum stroke length of the piston/plunger to prevent accidental withdrawal of the plunger/piston from the syringe barrel (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to place a limiter in the invention of Taylor corresponding to the maximum stroke length of the piston (which therefore corresponds to the maximum compressible distance of the handles since it is the handles which define the piston stroke length), as disclosed by Grimard, in order to prevent the piston from being accidentally displaced from the piston rod when the handles are fully compressed. Again, based on the correlation between piston displacement and handle compression in Taylor, it will; be understood that the limiter of modified Taylor effectively stops any further compression of the handles because the limiter will stop rearward displacement of the plunger and so no further compression will be possible.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant’s remarks to respect to the double patenting are conclusory and do not attempt to explain how the instant claim limitations create a non-coextensive scope. Specifically, as noted above a unitary wall construction for a syringe barrel is understood as commonplace and standard and therefore would not be understood to distinguish the claims of the instant application over the reference patent claims and the limitations directed toward correlating the aspiration fluid volume to the compressible distance of the handle necessarily flow from the manner in which the invention of the reference patent is claimed as operating (re: “compressing the compressible handle causes the handle to longitudinally extend and causes the syringe plunger to move rearwardly in the syringe barrel away from the needle”), whereby it will be understood that since the compression of the handles is used to move the piston the maximum distance by which the handles can be compressed corresponds to the maximum distance that the piston can be operatively displaced and therefore defines the maximum aspiration volume of the syringe in operation. As such, this feature cannot define and distinguish over the claimed subject matter of the reference patent and Double Patenting is still applicable.
With respect to Taylor, Examiner submits that based on the written description of the publication it would be well-understood by the ordinary artisan that the aspiration volume of a syringe is the result of the stroke length of the piston whereby the further the piston is retracted/withdrawn the larger the aspirated volume. In operation the syringe of Taylor is dependent upon compression of the handles to retract/withdraw the piston by which the more the handles are compressed the further the piston is withdraw (see generally Fig. 2 and 6 – compare the uncompressed configuration shown in solid with the compressed configuration shown in phantom). There presents a maximum distance that the handles can be compressed based on their displacement toward the syringe barrel, which therefore would define a corresponding maximum withdrawal/retraction of the handle, which would therefore define a corresponding maximum fill volume – i.e. there presents a point where no further compression of the handles is possible, therefore no further retraction of the piston incident to compression is possible, and therefore no further increase in volume of the syringe chamber is possible.
With respect to the “internal locking mechanism” disclosed by Taylor with respect to the first and fourth embodiments, Examiner submits that the operation of such a mechanism is irrelevant to operation of the relied upon embodiment, i.e. that of Fig. 4 which does NOT incorporate any “internal locking mechanism”. Rather in this embodiment, it will be understood that the handles (60) are compressed to a user until the desired aspiration fill volume is reached incident to the induced withdrawal of the piston pursuant to handle compression. As such, the maximum compression of the handles causes a maximum withdrawal of the piston which defines the corresponding maximum fill volume.
Applicant argues (Pg. 12) that “octagon member 151, however, is not readily compatible with the second and third embodiments of Taylor”. However, this is not persuasive. Firstly, Examiner notes that Applicant presents substantial consideration of the hemispherical embodiment of Fig. 6, whereas the instant rejection primarily concerns itself with then embodiment of Fig. 4. Reference is made to Fig. 6 (and Fig. 2) because these embodiments are illustrated showing the compression of the handle members, whereas Taylor does not illustrate compression of the handles in the embodiment of Fig. 4.
Furthermore, Taylor clearly illustrates that the octagon shape is a direct replacement (compare Fig. 1 and 9) for a circular shape (compare Fig. 3 and 4). As such, the ordinary artisan would reasonably recognize and appreciate that the circular shape of (60 – corresponding to the shape of the ring 14 – Fig. 1) could be similarly replaced with an octagon shape in the same manner that the circular ring (14 – Fig. 1) has been replace with an octagonal shape (150) between the species of Figs. 1 and 9. Taylor establishes the two shapes to be suitable, known equivalents/alternatives to one another. Here, the octagon shape operates in a substantially similar manner to the circular handle shape, i.e. the two sides (160, 162) are compressed toward the longitudinal axis of the syringe barrel in order to induce a withdrawal/retraction of the piston/plunger (see Fig. 9 – compare solid with phantom). Taylor explicitly recites in reference to this embodiment “Here it will be seen that ring 14 of the arming device 10 is replaced by a [sic] octagon member 151…” which clearly establishes the equivalence of the two shapes as replacements to one another. Merely because Taylor does not explicitly discuss replacement of the ring/circular shaped handle (60) of the embodiment of Fig. 4 with an octagon shaped handle configuration is immaterial with respect to obvious inasmuch as the authors of Taylor cannot possibly be expected to particularly enumerated every single obvious modification to the disclosed inventions. Taylor, recognizing this, recites “modifications may be made to the arming devices of the present invention without departing from the teachings thereof” which would denote to the ordinary artisan that the express configurations illustrated are not critical, but rather various modifications can be provided to the disclosed embodiments while maintaining the basic inventive concept and operation of the invention. The ordinary artisan, recognizing the similarity of the ring shaped handles (14) of the first embodiment (Fig. 1) and the ring shaped handles (60) of the third embodiment (Fig. 4) would reasonably recognize and appreciate that the ring shaped handle (60) could similarly be replaced with an octagon shape (see 150) without departing from the crux of the invention. Particularly, it is well understood that simple substitution of established equivalents is obvious, requiring only routine and customary skill in the art, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) and mere modifications to the shape of an invention which affect only expected and predictable results are also obvious, requiring only routine and customary skill in the art, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
With respect to Applicant’s arguments concerning a lack of direction as to adapting the connecting interface of the handle (150) of the embodiment of Fig. 9/10 to function with association of a syringe (90) of the type of the embodiment of Fig. 4 – Examiner submits that the ordinary artisan is also of ordinary knowledge, understanding, and creativity – not an automaton – and does not need an express road map detailing a step-by-step process for combining two inventions. Rather, the ordinary artisan will be expected to use common sense and basic design principles to determine, via routine processes, how components of inventions may be actually reduced to practice (versus merely constructively reduced to practice via broad recognition of obvious modifications and concepts). Here, adapting the connecting interface (152, 154) to work with the connecting interface of the syringe (90, 66) of Fig. 4 is a trivial design task that requires only nominal consideration as to adjusting the connecting interface (152, 154) to assume a configuration akin to that (82, 72) which permits the equivalent handle syringe (90) to interface with the handle. Such a modification is largely a change in shape and substitution of known equivalent connection interfaces. Specifically, the proximal connecting opening (154) and wall portion (158) can simply be modified to utilize the keyhole type design (70, 80, 82) previously employed by Taylor. Likewise the proximal connecting opening (152) and wall portion (156) can be modified to utilize an open faced notch (72) thereby permitting the rear portion of the handle to operatively couple with the piston and the front portion of the handle to operatively couple the syringe/carrier.
Taylor establishes that an octagonal handle operates substantially similar to a circular handle (compare 14 with 150) and therefore establishes the two shapes to be predictable alternatives to one another (re: Taylor recognizes that the octagon handle is explicitly a “replacement” for the ring shaped handle). Regardless of the change in shape of the handle the two configurations operate substantially similar whereby a maximum compression of the handle denotes a maximum volume which can be effected by compression of the handle, and therefore satisfies the claimed subject matter. Specifically, since the syringe (Fig. 4) is aspirated via compressing the handle (60) replacing the circular shape with an obvious alternative shape (octagon), as established by Taylor, will not materially change this operational concept. In other words, the piston will move back a length corresponding to the distance of compression of the handles (since compressing the handles radially causes them to elongate in the longitudinal direction), whereby the maximum compressible distance of the handles defines the maximum distance by which the piston will move backwards. This maximum stroke length of the piston defines the maximum volume which can be aspirated via compression of the handles.
Applicant argues “The Office Action does not assert any rejection of the coupling between the respective first handles and the plunger extension”. However, this is not persuasive. Specifically, Taylor, as modified by Goldberg, provides for the plunger extension to be configured as part of the flange, whereby Examiner has established that in Taylor the flange is coupled with the proximal end of the handle. Specifically, in Taylor the first handles are operatively coupled to the flange of the piston/plunger (see via 80, 82) which permits the handles to operatively abut the plunger flange (see Fig. 5) such that proximal displacement of the handles incident to compression therefore creates proximal displacement of the piston by operating on the plunger flange. Examiner notes that in no embodiments does Applicant illustrate direction connection between the extension, per se, and the handles (See e.g. Fig. 7A-7C) therefore, it must be understood that connection to the extension via an intermediary (re: the plunger second end flange) is permissive.
Goldberg is not relied upon to teach the handles and therefore is not relied upon to teach the coupling the handles with the flange (or the extension). Rather such coupling is a product of the obvious modifications to Taylor wherein the flange of Taylor is modified to include an extension, with the flange being already coupled to the proximal end of the handle such that proximal movement of the proximal end of the handle abuts against the flange and causes withdrawal of the piston/plunger. Again, Examiner reiterates that Applicant does not appear to disclose ANY embodiments wherein the handles are directly coupled to the extension, per se, rather all coupling with the extension occurs indirectly via coupling between the handles and flange (see Figs. 7A-7C, see also Fig. 8A, 8B)
Conclusion
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).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 03/05/2026