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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 has been amended to require the “volume of gas” be in the same structure (“collapsible fluid chamber”, “dispensing chamber”, or “cylindrical neck”) as the “volume of liquid” of claim 11. However, paragraph [0023] appears to set forth that the volume of liquid and the volume of gas are intended to be within different structures. Because the claimed relationship contradicts the relationship disclosed in the Specification, it is unclear how to interpret claim 12 in light of the Specification. For the sake of examination, claim 12 is interpreted such that the volume of liquid and the volume of gas are within separate structures since this is the relationship supported by the Specification. Accordingly, it is suggested to amend claim 12 to recite “wherein another of the collapsible fluid chamber, the dispensing chamber, and the cylindrical neck
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Koska (PG PUB 2019/0060168).
Re claim 1, Koska discloses a pre-filled medical delivery device 710+226 (BFS vial 710 is shown in Fig 7A-7G and administration assembly 226 is shown in Fig 2D,2E,2G-2I), comprising: a blow-fill-seal (BFS) vial 710 (Fig 7A-7G) defining a collapsible fluid chamber 720a (Fig 7A-7G), a dispensing chamber 720b (Fig 7A-7G) in communication with the collapsible fluid chamber (Para 79), a neck portion 712 (Fig 7A-7G) in communication with the dispensing chamber (Para 79), and an exterior flange 716+718a+718b (Fig 7A-7G) formed on the neck portion (as seen in Fig 7A-7G), wherein the exterior flange comprises an axially elongated and rounded protrusion 716 (Fig 7A-7G) having a flange length (extending vertically in Fig 7D); and an administration assembly 226 (Fig 2D,2E,2G-2I) defining an opening 232-1 (Fig 2G) at one end (to the left in Fig 2D), the opening being in communication with an interior volume (as seen in Fig 2J-2L) comprising an interior seat 234a (Fig 2D,2E,2G) into which the exterior flange is axially mated, and the administration member comprising, at a second end (to the right in Fig 2D), a needle 280 (Fig 2D; Para 46). Koska does not explicitly disclose the flange length or a length of the neck portion and, therefore, does not disclose that the flange length is 30-45% of a length of the neck portion. However, Koska discloses that the ratio of the flange length to the length of the neck portion is a result effective variable (see Para 65 which sets forth that the length of the flange and the length of the neck portion are chosen so that the flange ensures that the neck portion can be mated within the administration assembly in a manner that prevents axial movement of the vial with respect to the administration assembly). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the flange to have a length that is 30-45% of a length of the neck portion.
Re claim 2, Koska discloses that the BFS vial further comprises: a constriction (seen in Fig 7A-7G and labeled in annotated Fig A below) between the fluid chamber and the dispensing chamber (as seen in Fig 7A-7G and Fig A below).
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Re claim 3, Koska discloses all the claimed features except explicitly disclosing that the constriction comprises a diameter in the range of 3 mm to 4 mm. However, Koska discloses that the diameter of the constriction is a result effective variable (see Para 80 which discloses that the size of the constriction defines the substantial disk-shapes of the chambers which allow the chambers to reduce their volume when squeezed to substantially zero and expel substantially all substance stored therein). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the constriction to have a diameter in the range of 3 mm to 4 mm.
Re claim 4, Koska discloses all the claimed features except explicitly disclosing that the exterior flange is rounded at a radius in the range of 4 mm to 5 mm. However, Koska discloses that the radius of the exterior flange is a result effective variable (see Para 65 which sets forth that the shape of the flange (which includes its radius) is chosen so that the flange ensures that the vial can be mated within the administration assembly in a manner that prevents axial movement of the vial with respect to the administration assembly). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the exterior flange to be rounded at a radius in the range of 4 mm to 5 mm.
Re claim 5, Koska discloses that the exterior flange extends radially outward from the neck portion by a protrusion amount (as seen in Fig 7A-7G), but does not explicitly disclose that the flange length is in the range of 4.3 times to 5.3 times the protrusion amount. However, Koska discloses that the ratio of the protrusion amount and the flange length is a result effective variable (see Para 65 which sets forth that the shape of the flange (which includes its length and protrusion amount) is chosen so that the flange ensures that the vial can be mated within the administration assembly in a manner that prevents axial movement of the vial with respect to the administration assembly). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the protrusion amount and the flange length so that the flange length is in the range of 4.3 times to 5.3 times the protrusion amount.
Re claim 6, Koska discloses a blow-fill-seal (BFS) vial 710 (Fig 7A-7G), comprising: a collapsible fluid chamber 720a (Fig 7A-7G); a dispensing chamber 720b (Fig 7A-7G) in communication with the collapsible fluid chamber (Para 79); a cylindrical neck portion 712 (Fig 7A-7G) in communication with the dispensing chamber (Para 79); and an exterior flange 716+718a+718b (Fig 7A-7G) formed on the neck portion (as seen in Fig 7A-7G), wherein the exterior flange extends radially outward from the neck portion by a protrusion amount and has an axial length (as seen in Fig 7A-7G). Koska does not explicitly disclose that the axial length of the exterior flange is in the range of 4.3 times to 5.3 times the protrusion amount. However, Koska discloses that the ratio of the protrusion amount and the flange length is a result effective variable (see Para 65 which sets forth that the shape of the flange (which includes its axial length and protrusion amount) is chosen so that the flange ensures that the vial can be mated within the administration assembly in a manner that prevents axial movement of the vial with respect to the administration assembly). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the protrusion amount and the axial length of the exterior flange so that the axial length is in the range of 4.3 times to 5.3 times the protrusion amount.
Re claim 7, Koska discloses all the claimed features except explicitly disclosing that the axial length of the exterior flange is in the range of 30-45% of a length of the neck portion. However, Koska discloses that the ratio of the axial length of the exterior flange to the length of the neck portion is a result effective variable (see Para 65 which sets forth that the length of the flange and the length of the neck portion are chosen so that the flange ensures that the neck portion can be mated within the administration assembly in a manner that prevents axial movement of the vial with respect to the administration assembly). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the flange to have an axial length that is 30-45% of a length of the neck portion.
Re claim 8, Koska discloses that the BFS vial further comprises: a constriction (seen in Fig 7A-7G and labeled in annotated Fig A above) between the fluid chamber and the dispensing chamber (as seen in Fig 7A-7G and Fig A above).
Re claim 9, Koska discloses all the claimed features except explicitly disclosing that the constriction comprises a diameter in the range of 3 mm to 4 mm. However, Koska discloses that the diameter of the constriction is a result effective variable (see Para 80 which discloses that the size of the constriction defines the substantial disk-shapes of the chambers which allow the chambers to reduce their volume when squeezed to substantially zero and expel substantially all substance stored therein). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the constriction to have a diameter in the range of 3 mm to 4 mm.
Re claim 10, Koska discloses all the claimed features except explicitly disclosing that the exterior flange is rounded at a radius in the range of 4 mm to 5 mm. However, Koska discloses that the radius of the exterior flange is a result effective variable (see Para 65 which sets forth that the shape of the flange (which includes its radius) is chosen so that the flange ensures that the vial can be mated within the administration assembly in a manner that prevents axial movement of the vial with respect to the administration assembly). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the exterior flange to be rounded at a radius in the range of 4 mm to 5 mm.
Re claim 11, Koska discloses that at least one of the collapsible fluid chamber, the dispensing chamber, and the cylindrical neck is filled, during manufacture, with a volume of liquid (Para 54).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Koska (PG PUB 2019/0060168) in view of Basile et al. (WO 2015/187518).
Re claim 12, Koska discloses all the claimed features but is silent as to whether or not a volume of gas is contained in at least one of the collapsible fluid chamber, the dispensing chamber, and the cylindrical neck. Basile, however, teaches a blow-fill-seal vial 10 (Fig 2; Page 15, Lines 30-31) comprising a collapsible fluid chamber (as seen in Fig 2, the vial contains four chambers, each comprising a first surface 14, a second surface 16 and a bellows 12 therebetween; the “collapsible fluid chamber” can be any of these chambers), a dispensing chamber (as seen in Fig 2, the vial contains four chambers, each comprising a first surface 14, a second surface 16 and a bellows 12 therebetween; the “dispensing chamber” can be any other of these chambers) and a neck portion 15 (Fig 2) and teaches that BFS vials commonly contain a volume of liquid in at least one of the chambers and the neck portion and a volume of gas in at least one of the chambers and the neck portion (Page 6, Lines 8-10) for the purpose of enabling priming of the vial (Page 6, Lines 10-11). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Koska to include a volume of gas in one of the chambers or the cylindrical neck, as taught by Basile, for the purpose of priming the vial (Page 6, Lines 10-11).
Re claim 13, Koska as modified by Basile in the rejection of claim 12 above discloses all the claimed features except explicitly disclosing that the volume of gas is in the range of 100% - 250% of the volume of liquid. However, Basile discloses that the ratio of gas to liquid is a result effective variable (see Page 6, Lines 8-11 which disclose that the vial consists of a volume of gas and a volume of liquid and the amount of gas in the vial affects the amount of priming that must be done prior to delivery of the liquid). Since it has been held that discovering an optimum range of a result effective variable involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the amount of gas and the amount of liquid in the vial such that the volume of gas in in the range of 100% to 250% of the volume of liquid.
Response to Arguments
Applicant's arguments filed 6/22/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that claims 12 and 13 are definite, the Examiner respectfully disagrees. Specifically, Applicant argues that the language of the Specification does not conflict with the language of claim 12 (“which recites that “the at least one of the collapsible fluid chamber, the dispensing chamber, and the cylindrical neck also comprises a volume of gas”). The Examiner disagrees since claim 12 requires that the structure or structures that are filled with liquid during manufacture (as recited in claim 11) also comprise gas; that is, if one of the three structures recited in claim 11 is filled during manufacture with liquid, then that one structure also comprises gas; if two of the three structures recited in claim 11 are filled during manufacture with liquid, then those two structures also comprise gas; if all three structures recited in claim 11 are filled during manufacture with liquid, then all three structures also comprise gas. Paragraph [0023] of the Specification, on the other hand, recites that “it may be advantageous to have the liquid retained in the second chamber 222 while the gas is separated into the first chamber 220”; that is, one structure contains liquid while another structure contains gas. Therefore, the language of claim 12 conflicts with the Specification, rendering it unclear how to interpret claim 12 in light of the Specification as required by MPEP 2111.
The Examiner agrees with Applicant’s assertion that the collapsible fluid chamber, the dispensing chamber, and the cylindrical neck are all in fluid communication, but it is not apparent how these three being in fluid communication supports liquid and gas both being contained within the collapsible fluid chamber, liquid and gas both being contained within the dispensing chamber, and/or liquid and gas both being contained within the cylindrical neck.
Regarding Applicant’s argument that Koska does not establish that the “axial length of the flange” and the “length of the neck portion” are result effective variables, the Examiner respectfully disagrees. Specifically, Applicant argues that “there is no language in the cited paragraph [65 of Koska] that even mentions the ‘axial length of the flange’ (variable #1) or the ‘length of the neck portion’ (variable #2), much less set forth any evidence that supports the Examiner’s assertion regarding ‘result effective variables’ with respect to variables #1 and #2”. First, although Applicant refers to variable #1 as an “axial length of the flange”, it is noted that the claim language only requires “a flange length” of the “axially elongated and rounded protrusion” and does not require this “flange length” to be an “axial” length. Second, it is noted that the claimed feature that is rejected as a result effective variable is the ratio of a length of the flange to a length of the neck portion (since claim 1 recites “wherein the exterior flange comprises an axially elongated and rounded protrusion having a flange length in the range of thirty to forty-five percent (30% - 45%) of a length of the neck portion”). Third, paragraph 65 of Koska sets forth that the ratio of the size of the protrusion of the flange and the length of the neck portion affects the ability of the vial to be mated with a specific seat of the administration assembly; therefore, this ratio is a result effective variable since the changing of this ratio would affect the ability of the vial and the administration to be mated.
Regarding Applicant’s argument that the Examiners “fails to recognize a third variable set forth in the claimed limitations, namely, ‘the protrusion amount’ (variable #3)”, the Examiner respectfully disagrees. Specifically, Applicant argues that “The Examiner makes no argument and provides no evidence that variable #3 is address, much less defined as a ‘result effective variable’ in Koska”. However, this variable is address in the rejection of claim 5 which asserts that paragraph 65 of Koska sets forth that the ratio of the protrusion amount to the flange length affects the ability of the vial to be mated with a specific seat of the administration assembly; therefore, this ratio is a result effective variable since the changing of this ratio would affect the ability of the vial and the administration assembly to be mated.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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