DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1 and 9-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication No. 2011/0034882 to Quinn et al., herein referred to as Quinn, alone.
The applied reference has a common inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
Regarding claim 1, Quinn teaches a stopper (12, Fig. 29) capable of attachment with a plunger rod for use within a syringe barrel (neither the plunger nor the syringe barrel are positively recited, but the stopper is capable of attachment thereto), the stopper comprising a main body portion (body of 12) defining an open rearward end (28) configured to receive the plunger rod, an engagement portion comprising a protruding portion provided along an inner circumference of the main body portion, the protruding portion comprising an upwardly angled portion (198) and a downwardly angled portion (angled portion of stopper above 198), which together form the protruding portion, the protruding portion configured to engage a notched portion (formed between 330 and 332) of the plunger rod (since the plunger rod is not positively recited, the protruding portion is capable of engaging a notched portion of a plunger rod), wherein the notched portion of the plunger rod has a shape that is complementary to the protruding portion such that a portion of the upwardly angled portion and a portion of the downwardly angled portion of the protruding portion engage the notched portion (given the broadest reasonable interpretation, the upwardly angled portion engages 196 upon as the plunger is moved forward during injection and the downwardly angled portion engages 332 upon retraction of the plunger during aspiration, in any case, since the plunger is not positively recited, the upwardly and downwardly angled portion are capable of engaging a notched portion having a complementary shape), the main body further comprising a closed front end forming a flexible roof (30), and a first perimetrical skirt (rib 46 and associated upper skirt, Fig. 29) extending around an outer circumference of the main body portion toward the closed front end of the main body portion, wherein, when fluid pressure is increased inside the syringe barrel during an injection, the flexible roof expands in a radial direction toward an inner wall of the syringe barrel, the first perimetrical member is forced against the inner wall of the syringe barrel, and an engagement between the notched portion of the plunger rod and the upwardly angled portion forces the main body portion to expand in the radial direction toward the inner wall of the syringe barrel, thereby providing a sealing pressure between the stopper and the inner wall of the syringe barrel (the main body portion is capable of expansion upon engagement of a plunger upon the upwardly angled portion, also [0133]) and wherein during an aspiration, the engagement between the notched portion of the plunger rod and the downwardly angled portion forces the main body to expand in the radial direction toward the inner will of the syringe barrel to provide a sealing pressure between the stopper and the inner wall of the syringe (upon aspiration, the downwardly angled portion of the main body 26 is capable of engagement with a plunger rod, thereby providing expansion of the main body), but does not teach the conical front end.
Quinn teaches a closed front end of the main body having a conical shape with a tip (as exemplified in embodiment of Figs. 5A and 5B in Quinn) wherein the closed front end of the main body portion includes a first angled portion and second angled portion forming a single conical surface that extends toward a top providing a closed front end (the first and second angled portions are merely two halves of the conical tip, the conical tip of the embodiment of Figs. 5A and 5B also has two angled portions that form the tip inasmuch as Applicant’s angled portions). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nose portion of the tip of the embodiment of Fig. 29 of Quinn to have a conical tip as exemplified in the embodiment of Figs. 5A and 5B because the two tip designs are obvious art-recognized alternatives. Quinn itself discloses the nose portion (34) of the flexible core member (32), as shown in the embodiment of Fig. 29 relied upon above, may include other shapes such as “substantially conical” ([0076]) and also discloses the expected result of such an alternative which would be allowing self-centering of the plunger with respect to the outlet opening.
Regarding claims 9 and 10, Quinn teaches the stopper of claim 1 as shown above, but is silent as to the thickness of the flexible roof and does not specifically disclose a range of about 0.1 mm to about 3 mm or about 0.3 to about 1.2 mm. It would have been obvious to one of ordinary skill in the art to cause the flexible roof of Quinn to have a thickness in the range of about 0.1 mm to about 3 mm or about 0.3 to about 1.2 mm, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the flexible roof of Quinn would not operate differently with the claimed thickness, as this thickness would be suitable for resisting unnecessary deformation and allowing the force applied by the plunger rod to the protruding portion to be applied to the distal rib member.
Regarding claims 11 and 12, Quinn teaches the stopper of claim 1 as shown above, but is silent as to the thickness of the first perimetrical skirt and does not specifically disclose a range of about 0.05 mm to about 3 mm or about 0.2 mm to about 0.5 mm. It would have been obvious to one of ordinary skill in the art to cause the first perimetrical skirt of Quinn to have a thickness in the range of about 0.05 mm to about 3 mm or about 0.2 to about 0.5 mm, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the first perimetrical skirt of Quinn would not operate differently with the claimed thickness, as this thickness would be suitable for providing sufficient contact between the perimetrical skirt and the syringe barrel.
Regarding claim 13, Quinn teaches the stopper of claim 1, as shown above, Quinn further teaching a second perimetrical skirt (formed below 46, Fig. 29) extending around an outer surface of the main body such that the second perimetrical skirt provides stability to the stopper in the axial direction (the portions of the second skirt abutting the syringe barrel would provide stability as they abut the syringe barrel), wherein, when fluid pressure is decreased inside the syringe barrel during an aspiration, the second perimetrical skirt is forced against the inner wall of the syringe barrel, thereby providing a sealing pressure between the stopper and the inner wall of the syringe (upon retraction, the second skirt would naturally abut the inner wall, and would be further aided in providing a sealing pressure as front flange 332 abuts sloped portion above 331).
Regarding claims 14 and 15, Quinn teaches the stopper of claim 13 as shown above, but is silent as to the dimensions of the second perimetrical skirt and do not specifically disclose a thickness of about 0.05 mm to about 3 mm and a length of about 1 mm to about 100 mm or a thickness of about 0.2 mm to about 0.5 mm. It would have been obvious to one of ordinary skill in the art to cause the second perimetrical skirt of Quinn to have a thickness in the range of about 0.05 mm to about 3 mm or about 0.2 to about 0.5 mm and a length of about 1 mm to about 10 mm, since it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device (MPEP 2144.04 IV, A). In the instant case, the second perimetrical skirt of Quinn would not operate differently with the claimed thickness and length, as these dimensions would be suitable for providing plunger stability.
Regarding claim 16, Quinn teaches the stopper of claim 1, Quinn further teaching the protruding portion has a conical cross-sectional shape (Fig. 29) and the notched portion of the plunger rod is located at a top portion of the plunger rod and is formed around an outer circumference thereof (again, since the plunger rod is not positively recited, further limitations of “notch” will not be given patentable weight), the notch comprising an upwardly angled portion and a downwardly angled portion, which together form, the notch wherein, each of the upwardly angled portion and the downwardly angled portion forms an acute angle with a horizontal line extending between the upwardly angled portion and the downwardly angled portion having a conical cross-section that engages the protruding portion of the main body such that conical cross-section of the notch has a shape that is complementary to the conical cross-section of the protruding portion (again, since the plunger rod is not positively recited, further limitations of the “notch” will not be given patentable weight, in any case, the protruding portion is capable of engagement with a plunger rod having a upwardly and downwardly angled portion) such that engagement between the plunger rod and the protruding portion during both an injection and an aspiration forces the main body portion to expand in the radial direction toward the inner wall of the syringe barrel during both an injection and an aspiration (the protruding portion of the main body is capable of engagement with a plunger rod to cause expansion [0133])
Regarding claim 17, Quinn teaches a syringe (Fig. 1) comprising a substantially cylindrical syringe barrel (16) comprising a fluid dispensing end (18) and an open end (22), a stopper (12, Fig. 29) configured to be received within the open end of the syringe barrel, the stopper comprising a main body portion (body of 12) defining an open rearward end (28) configured to receive the plunger rod, an engagement portion comprising a protruding portion provided along an inner circumference of the main body portion, the protruding portion comprising an upwardly angled portion (198) and a downwardly angled portion (portion of stopper above 198), which together form the protruding portion, and a closed front end forming a flexible roof (30) and a first perimetrical skirt (rib 46 and associated upper skirt, Fig. 29) extending around an outer circumference of the main body portion toward the closed front end of the main body portion (Fig. 29), a plunger rod (324) having a plunger rod body (body of 324) extending along a longitudinal axis (central axis of 324), the plunger rod body comprising a front attachment end (upper portion of 324) and a back end (lower portion of 324), the front attachment end including a notched portion (formed between 330 and 332) configured to engage the engagement portion (at least at 196/198) provided along the inner circumference of the main body portion of the stopper, wherein the notched portion of the plunger rod has a shape that complementary to the protruding portion of the stopper such that a portion of the upwardly angled portion and a portion of the downwardly angled portion of the protruding portion engages the notched portion (a portion of the upwardly angled portion engages 196 upon injection as the plunger is moved forward and a portion of the downwardly angled portion engages 332 upon retraction of the plunger, thereby making the notched portion complementary as defined in the claim), wherein, when fluid pressure is increased inside the syringe barrel during an injection, the flexible roof expands in a radial direction toward an inner wall of the syringe barrel, the first perimetrical member is forced against the inner wall of the syringe barrel, and an engagement between the notched portion of the plunger rod and the upwardly angled portion forces the main body portion to expand in the radial direction toward the inner wall of the syringe barrel (the main body portion expands upon engagement of a plunger upon the upwardly angled portion, also [0133]), thereby providing a sealing pressure between the stopper and the inner wall of the syringe barrel (plunger 324 applies a radial force to the rib 46 and associated upper skirt as taper 198 contacts sloped portion 331 upon application of a forward force to the plunger rod, also [0133]) and wherein during an aspiration, the engagement between the notched portion of the plunger rod and the downwardly angled portion forces the main body to expand in the radial direction toward the inner will of the syringe barrel to provide a sealing pressure between the stopper and the inner wall of the syringe (upon aspiration, flange 332 would abut the upper inner taper of the main body 26 thereby providing expansion of the main body), but does not teach the conical front end.
Quinn teaches a closed front end of the main body having a conical shape with a tip (as exemplified in embodiment of Figs. 5A and 5B in Quinn) wherein the closed front end of the main body portion includes a first angled portion and second angled portion forming a single conical surface that extends toward a top providing a closed front end (the first and second angled portions are merely two halves of the conical tip, the conical tip of the embodiment of Figs. 5A and 5B also has two angled portions that form the tip inasmuch as Applicant’s angled portions). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nose portion of the tip of the embodiment of Fig. 29 of Quinn to have a conical tip as exemplified in the embodiment of Figs. 5A and 5B because the two tip designs are obvious art-recognized alternatives. Quinn itself discloses the nose portion (34) of the flexible core member (32), as shown in the embodiment of Fig. 29 relied upon above, may include other shapes such as “substantially conical” ([0076]) and also discloses the expected result of such an alternative which would be allowing self-centering of the plunger with respect to the outlet opening.
Regarding claim 18, Quinn teaches the syringe of claim 17 as shown above, Quinn further teaching a front attachment end (324) of a syringe plunger body comprising an extension portion (see annotated Fig. 29 in previous Office Action) configured to contact a lower surface of the flexible roof (30) during an injection, thereby limiting the expansion of the flexible roof in the radial direction (by limiting rearward movement of roof 30).
Regarding claim 19, Quinn teaches a plunger rod (324, Fig. 29) and stopper assembly (12) capable of use with a syringe barrel (the syringe barrel is not positively recited, but the plunger rod and stopper assemble of Quinn are capable of use therewith), the assembly comprising a stopper (12) comprising a main body portion (body of 12) defining an open rearward end (28) configured to receive the plunger rod, an engagement portion comprising a protruding portion provided along an inner circumference of the main body portion, the protruding portion comprising an upwardly angled portion (198) and a downwardly angled portion (portion of stopper above 198), and a closed front end forming a flexible roof (30), and a first perimetrical skirt (rib 46 and associated upper skirt, Fig. 29) extending around an outer circumference of the main body portion toward the closed front end of the main body (Fig. 29), and a plunger rod (324) having a plunger rod body (body of 324) extending along a longitudinal axis (central axis of 324), the plunger rod body comprising a front attachment end (upper portion of 324) and a back end (lower portion of 324), the front attachment end including a notched portion (formed between 330 and 332) configured to engage the engagement portion provided along the inner circumference of the main body portion of the stopper, wherein the notched portion of the plunger rod has a shape that is complementary to the protruding portion of the stopper such that a portion of the upwardly angled portion and a portion of the downwardly angled portion of the protruding portion engages the notched portion (a portion of the upwardly angled portion engages 196 upon injection as the plunger is moved forward and a portion of the downwardly angled portion engages 332 upon retraction of the plunger, thereby making the notched portion complementary as defined in the claim), wherein, when fluid pressure is increased inside the syringe barrel during an injection, the flexible roof expands in a radial direction toward an inner wall of the syringe barrel, the first perimetrical skirt is forced against the inner wall of the syringe barrel, and an engagement between the notched portion of the plunger rod and the upwardly angled portion forces the main body portion to expand in the radial direction toward the inner wall of the syringe barrel (the main body portion expands upon engagement of a plunger upon the upwardly angled portion, also [0133]), thereby providing a sealing pressure between the stopper and the inner wall of the syringe barrel (plunger 324 applies a radial force to the rib 46 and associated upper skirt as taper 198 contacts sloped portion 331 upon application of a forward force to the plunger rod, also [0133]) and wherein during an aspiration, the engagement between the notched portion of the plunger rod and the downwardly angled portion forces the main body to expand in the radial direction toward the inner will of the syringe barrel to provide a sealing pressure between the stopper and the inner wall of the syringe (upon aspiration, flange 332 would abut the upper inner taper of the main body 26 thereby providing expansion of the main body), but does not teach the conical front end.
Quinn teaches a closed front end of the main body having a conical shape with a tip (as exemplified in embodiment of Figs. 5A and 5B in Quinn) wherein the closed front end of the main body portion includes a first angled portion and second angled portion forming a single conical surface that extends toward a top providing a closed front end (the first and second angled portions are merely two halves of the conical tip, the conical tip of the embodiment of Figs. 5A and 5B also has two angled portions that form the tip inasmuch as Applicant’s angled portions). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nose portion of the tip of the embodiment of Fig. 29 of Quinn to have a conical tip as exemplified in the embodiment of Figs. 5A and 5B because the two tip designs are obvious art-recognized alternatives. Quinn itself discloses the nose portion (34) of the flexible core member (32), as shown in the embodiment of Fig. 29 relied upon above, may include other shapes such as “substantially conical” ([0076]) and also discloses the expected result of such an alternative which would be allowing self-centering of the plunger with respect to the outlet opening.
Regarding claim 20, Quinn teaches the syringe of claim 19 as shown above, Quinn further teaching a front attachment end (324) of a syringe plunger body comprising an extension portion (see annotated Fig. 29 in previous Office Action) configured to contact a lower surface of the flexible roof (30) during an injection, thereby limiting the expansion of the flexible roof in the radial direction (by limiting rearward movement of roof 30).
Claims 4-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Quinn in view of U.S. Patent Publication No. 2006/0229568 to Koopman.
Regarding claim 4, Quinn teaches the stopper of claim 1 as shown above, but does not explicitly specify the same material being used for different parts, although Quinn at least discloses the stopper ([0074]) and plunger rod ([0116]) being made of thermoplastic materials.
Koopman teaches the stopper (16), the plunger rod (14), and the syringe barrel (12) being manufactured from the same material ([0024], polypropylene). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the stopper, the plunger rod, and the syringe barrel of Quinn out of the same material, such as polypropylene, as taught by Koopman, because polypropylene is a conventional material used in syringes that is simple to manufacture, cost-effective, provides a sterile environment for receiving medicament, and is both sufficiently rigid and flexible in order to provide a simple yet effective means of medicament dispersion.
Regarding claim 5, Quinn and Koopman teach the stopper of claim 1 as shown above, Quinn further teaching the stopper being manufactured from a rigid or semi-rigid polymeric material ([0024], polypropylene).
Regarding claims 6 and 7, Quinn and Koopman teach the stopper of claim 5 as shown above, but are silent as to the elastic modulus of the material.
Quinn discloses that the stopper provides a seal with the outlet opening of the syringe barrel to prevent excess fluid from being forced out of the syringe once the stopper is bottomed out ([0076]). The range of elastic modulus is a result effective variable in that changing or adjusting the elastic modulus of the stopper is necessary to provide an optimal seal with the bottom of the barrel depending on the inner diameter of the syringe barrel, the outer diameter of the stopper, the material used for both syringe barrel and the stopper, as well as the properties of the fluid being injected, in order to provide a proper seal and prevent fluid escape. Further it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the stopper of Quinn and Koopman to have an elastic modulus in the range of about 0.01 GPa to about 5 GPa or of about 0.6 GPa to about 2 GPa as a matter of routine optimization since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, Quinn and Koopman teach the stopper of claim 6 as shown above, Koopman further teaching the rigid or semi-rigid polymeric material being a polyolefine ([0024], polypropylene is a type of polyolefine).
Response to Arguments
The specification amendments were received on 10/23/2025. These specification amendments are acceptable.
Applicant’s arguments and amendments with respect to specification objections have been fully considered and are persuasive. The specification objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant’s amendments and arguments with respect to the art rejections of claims 1, 17, and 19 have been fully considered and are not persuasive. Regarding claim 1, since the plunger rod is not positively recited, the new limitations regarding the notched portion of plunger rod are not given patentable weight, in any case the protruding portion of Quinn is capable of engaging a plunger rod with such features.
Regarding claims 17 and 19, Applicant argues that the L-shaped member is not a “notched portion.” Examiner respectfully disagrees. The notched portion of Quinn as shown above is not merely the front flange 332 alone but is formed between 332 and taper 330. Applicant also argues that portion 332 is not downwardly angled and is not complementary to the plunger rod such that the upwardly angled portion and the portion of the downwardly angled portion of the protruding portion engage the notched portion. Examiner respectfully disagrees. Examiner submits that there are no specific angles claimed as to define “downward” and that either the inner or outer sides of portion 332 as seen in Fig. 29 can be considered “downward” giving the broadest reasonable interpretation. Also, the definition of “complementary” in the claims is that the upwardly angled portion and the downwardly angled portion engages the notched portion and in the instant the case, the upwardly angled portion engages a portion of the plunger at least during injection and the downwardly angled portion engages a portion of the plunger at least during aspiration, thereby meeting the limitations of the claim. It is noted that separate engagement during injection and aspiration is not excluded from the claim, Examiner suggests incorporating language indicating that both the upwardly and downwardly angled portions engage the notched portion of the plunger simultaneously or during both injection and aspiration.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.K./Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783