DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “base wall being configured to receive a portion of the base” as claimed in claims 1 and 9, and all claims dependent thereupon, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-19 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. Specifically, both independent claims 1 and 9 (as well as all claimed dependent thereupon) comprise the limitation “the base wall being configured to receive a portion of the base.” Both claims define “the base” as comprising a base plate and the base wall, thus this limitation suggests that the base wall may receive another (presumably movable or removable) portion of the base other than the base plate and base wall. Such a configuration is not described or depicted within the specification of the present application. Rather, it appears from [0007] and [0012] of the specification that the applicant may have intended to refer instead to “a portion of a base of a vial or container” rather than to the “a base” defined within the present claims. Appropriate correction or cancelation is required.
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.
Claims 1-19 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 1 recites the limitation "the vial" in line 8. There is insufficient antecedent basis for this limitation in the claim, no “vial” feature being introduced anywhere within the claim. As a result, it is unclear to what structure or feature “the vial” refers, thereby rendering the scope of the claim indefinite. Claims 2-8 are also rendered indefinite due to their dependence upon claim 1. Appropriate correction is required.
Claim 9 recites the limitation "the vial" in line 10. There is insufficient antecedent basis for this limitation in the claim, no “vial” feature being introduced anywhere within the claim. As a result, it is unclear to what structure or feature “the vial” refers, thereby rendering the scope of the claim indefinite. Claims 10-19 are also rendered indefinite due to their dependence upon claim 9. Appropriate correction is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation “a viscosity of greater than about 100 cP at 25 °C and less than about 50,000 cP at 37 °C”, and the claim also recites “greater than about 100 cP at 25 °C and less than about 30,000 cP at 37 °C”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berg (WIPO Pub. No. 2021/099519).
Regarding claim 1, Berg discloses a device (fluid transfer device 1, embodiment of Fig. 1-3 and [0039-0064]) comprising: a base (lower housing part 20) that comprises a base plate (interpreted as the lower half of the lower housing part, including flat base 23 and surrounding rim wall – see annotated Fig. 2 below, [0060], and [0062]); a base wall (vertical cylindrical wall of receiving section 24) extending proximally from the base plate (see annotated Fig. 2 below, and see [0062]), the base wall being configured to receive a portion of the base (the compensation volume 9 and elastic functional element 13, which are portions of the base assembly received within the space surrounded by the lower portion of the base wall – see Fig. 2-3, [0060], and [0062]); a cap (upper housing part 19) having a proximal closed end (dome-shaped dome section 22) and configured to removably attach to the base (see Fig. 1-3, [0060-0061], and [0063-0064]), the proximal closed end having a proximal side (outward facing, top side, comprising leur connector/first connector section 3) and a distal side (inward facing, bottom side, comprising needle/second connector section 5) (see Fig. 1-3, [0041-0043], [0061], and [0063]), wherein the cap comprises a cap wall (hollow cylindrical shaft section 21) extending distally from the proximal closed end, the cap wall being configured to receive a neck and a portion of a vial (vial/liquid container 2) (see Fig. 1-3 and [0044]); and wherein the cap is configured to be removably attached to the base plate (see Fig. 1-3, [0014], [0060], and [0063-0064]).
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Regarding claim 2, Berg further discloses a grip (outer cylindrical wall comprising gripping/locking device 25) fixedly attached to the base (fixedly attached by virtue of being integrally formed with the base – see annotated Fig. 2 above, and [0063-0064]).
Regarding claim 3, Berg further disclose that the grip extends proximally from the base plate (see annotated Fig. 2 above, and [0063-0064], wherein the grip extend proximally from the rim wall portion of the base plate).
Regarding claim 4, Berg further discloses that the grip surrounds the base wall (see annotated Fig. 2 above).
Regarding claim 5, Berg further discloses that the cap wall forms an air-tight seal with the base when attached to the base ([0040], [0046], [0060], and [0063]).
Regarding claim 6, Berg further discloses that the distal side of the proximal closed end is configured to receive a needle (needle/second connector section 5) (see Fig. 1-3, [0041], [0043]).
Regarding claim 7, Berg further discloses that the proximal side of said proximal closed end is configured to receive a syringe (see Fig. 1-3 and [0041-0042]).
Regarding claim 8, Berg further discloses that the cap is configured to be removably attached to the base plate by inserting the cap wall between the grip and the base wall (Fig. 1-3, [0014], [0060], and [0063-0064]).
Regarding claim 9, Berg discloses a medical device (fluid transfer device 1, embodiment of Fig. 1-3 and [0039-0064]) comprising: a base (lower housing part 20) that comprises a base plate (interpreted as the lower half of the lower housing part, including flat base 23 and surrounding rim wall – see annotated Fig. 2 above, [0060], and [0062]); a base wall (vertical cylindrical wall of receiving section 24) extending proximally from the base plate (see annotated Fig. 2 above, and see [0062]), the base wall being configured to receive a portion of the base (the compensation volume 9 and elastic functional element 13, which are portions of the base assembly received within the space surrounded by the lower portion of the base wall – see Fig. 2-3, [0060], and [0062]); a grip (outer cylindrical wall comprising gripping/locking device 25) fixedly attached to the base (fixedly attached by virtue of being integrally formed with the base – see annotated Fig. 2 above, and [0063-0064]), the grip extending proximally from the base plate and surrounding the base wall (see annotated Fig. 2 above, and [0063-0064], wherein the grip extend proximally from the rim wall portion of the base plate); a cap (upper housing part 19) having a proximal closed end (dome-shaped dome section 22), which is configured to removably attach to the base (see Fig. 1-3, [0060-0061], and [0063-0064]), the proximal closed end having a proximal side (outward facing, top side, comprising leur connector/first connector section 3) and a distal side (inward facing, bottom side, comprising needle/second connector section 5) (see Fig. 1-3, [0041-0043], [0061], and [0063]); wherein the cap comprises a cap wall (hollow cylindrical shaft section 21) extending distally from the proximal closed end, the cap wall being configured to receive a neck and a portion of a vial (vial/liquid container 2) (see Fig. 1-3 and [0044]); wherein a distal side of the proximal closed end is configured to receive a needle (needle/second connector section 5) (see Fig. 1-3, [0041], [0043]), wherein a proximal side of the proximal closed end is configured to receive a syringe (see Fig. 1-3 and [0041-0042]), and wherein the cap is configured to be removably attached to the base plate by inserting the cap wall between the grip and the base wall (see Fig. 1-3, [0014], [0060], and [0063-0064]).
Regarding claim 10, Berg further discloses that the cap wall forms an air-tight seal with the base when attached to the base ([0040], [0046], [0060], and [0063]).
Regarding claim 11, Berg further discloses a method for withdrawing a composition (medication liquid) from its container, comprising inserting a container (vial/liquid container 2) comprising a composition into the device of claim 1 (see in re claim 1, and see [0057]).
Regarding claim 12, Berg further discloses the composition is withdrawn from the container while it is inserted in the device ([0040-0045] and [0059]).
Regarding claim 13, Berg further discloses that the composition is withdrawn with a needle (needle/second connector section 5) (see Fig. 2-3, [0040-0045], and [0059]).
Regarding claim 14, Berg further discloses that the needle is attached to a barrel of a syringe (see Fig. 2-3, [0040-0045], and [0059], wherein, upon connection of a syringe barrel to the leur connector/first connector section 3, the needle/second connector section 5 is thereby connected to the barrel of the syringe (both fluidly and structurally) via the leur connector/first connector section 3).
Regarding claim 15, Berg further discloses that the composition is a flowable composition (see [0040-0045] and [0059], wherein the medication liquid is drawn through needle/second connector section 5 merely by the vacuum created manually by the user using a syringe, therefore the medication liquid is flowable).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Berg in view of Doubet (U.S. Pat. Pub. No. 2021/0316084 A1), Tsals (U.S. Pat. No. 5,791,466), Nishioka (U.S. Pat. Pub. No. 2015/0290079 A1), and Tripp (U.S. Pat. No. 4,614,515).
Regarding claim 16, Berg discloses the method of claim 15. While Berg fails to explicitly describe that the flowable composition is a semi-solid composition or non-viscous composition (Berg giving no specific information as to the viscosity of the flowable composition), such compositions are common within the art (see Doubet, [0029], which describes that many medicinal compositions are of similar viscosity to water, and see Tsals, Col. 1, ln 14-17, which describes that many medicinal compositions are stored in semi-solid form), and it is well known to provide flowable semi-solid or non-viscous compositions within sealed glass vials (see Berg, [0044]; Tripp, Col. 1, ln 16-27; and Nishioka, [0009-0010]). Further, Tripp, which exhibits a device of the same type and purpose as Berg (see Tripp, Fig. 1-5 and Col. 2, ln 7-39), teaches that such sealed devices may be used to withdraw flowable medicinal compositions of gaseous, liquid, or solid composition (thereby including non-viscous and semi-solid compositions) (see Tripp, Col. 3, ln 3-35, Col. 4, ln 65 – Col. 5, ln 68, Col. 6, ln 50-54, and Claims). Such may be done in order to avoid contamination of the medicament during handling (see Tripp, Col. 1, ln 28-57) or unintended exposure of the user to medicament vapors (Berg, [0003-0004] and [0040], and Nishioka, [0009-0010]). For these reasons, it would have been obvious to one of ordinary skill in the art to utilize the method and device of Berg to withdraw a flowable semi-solid composition or non-viscous composition of medicament from a vial in order to avoid contamination of the medicament during handling or unintended exposure of the user to medicament vapors.
Regarding claim 19, While Berg fails to explicitly describe that the flowable composition is a non-viscous composition with a viscosity of less than or equal to 100 cP at 25 °C, such a range of viscosity falls within the characteristic range of viscosities for non-viscous compositions, and is exhibited by common injectable medicaments of similar viscosity to water (see Doubet, [0029]), such as aqueous solutions. It would therefore have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to apply the method and device of Berg to non-viscous compositions having viscosities of less than or equal to 100 Cp at 25 °C, which are common within the art, as described by Doubet, in order to thereby ensure that withdrawal of such medicaments does not contaminate the medicament or expose the user to harmful vapors, as described above in re claim 16.
Claim(s) 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Berg as modified by Doubet, Tsals, Nishioka, and Tripp according to claim 16, and in further view of Ng (U.S. Pat. Pub. No. 2002/0037300 A1).
Regarding claim 17, Berg as modified by Tripp and Tsals according to claim 16 discloses the method of claim 16, wherein it would have been obvious to use the method and device of Berg to withdraw a flowable semi-solid composition from the vial (see in re claim 16). While Berg fails to explicitly describe that the flowable composition is a semi-solid composition with a viscosity of greater than about 100 cP at 25 °C and less than about 50,000 cP at 37 °C, such a range of viscosity includes merely the less viscous (more flowable) portion of the known characteristic range of viscosity for semi-solid compositions, which may range from 10,000 cP to 500,000 cP, as taught by Ng (see [0052]). Since Berg is modified according to the teachings of Tripp and Tsals to comprise withdrawing flowable semi-solids, and since the method and device of Berg operate by withdrawing the composition through a needle (it being known that higher viscosity compositions are difficult to draw through a narrow needle), it follows that it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to apply the method and device of Berg to semi-solid compositions having viscosities within this most flowable range of viscosity of greater than about 100 cP at 25 °C and less than about 50,000 cP at 37 °C, in order to thereby ensure proper withdrawal of the medicament compositions from the vial.
Regarding claim 18, Berg as modified by Tripp and Tsals according to claim 16 discloses the method of claim 16, wherein it would have been obvious to use the method and device of Berg to withdraw a flowable semi-solid composition from the vial (see in re claim 16). While Berg fails to explicitly describe that the flowable composition is a semi-solid composition with a viscosity of greater than about 1000 cP and less than about 50,000 cP at 37 °C, such a range of viscosity includes merely the less viscous (more flowable) portion of the known characteristic range of viscosity for semi-solid compositions, which may range from 10,000 cP to 500,000 cP, as taught by Ng (see [0052]). Since Berg is modified according to the teachings of Tripp and Tsals to comprise withdrawing flowable semi-solids, and since the method and device of Berg operate by withdrawing the composition through a needle (it being known that higher viscosity compositions are difficult to draw through a narrow needle), it follows that it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to apply the method and device of Berg to semi-solid compositions having viscosities within this most flowable range of viscosity of greater than about 1000 cP and less than about 50,000 cP at 37 °C, since selection of such compositions ensures proper withdrawal of the medicament compositions from the vial is possible, and to ensure that withdrawal of such medicaments does not contaminate the medicament or expose the user to harmful vapors, as described above in re claim 16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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