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 Objections
Claims 1-14 are objected to because of the following informalities:
Claim 1 recites “or deliver” in line 1, which should instead read –or delivery--.
Claim 4 recites “is sealed” in line 3, which should read -- the second adapter component is sealed--.
Claim 5, recites “its hollow cylindrical section” in line 2, should instead read –the hollow cylindrical section of the second adapter component--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: delivery element in claim 1 and dependent claims
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. “With respect to the delivery element it should be noted that it may for example be a needle, a cannula, a spike or another type of perforation device” page 5.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-14 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.
Regarding claim 1, the phrase "can be" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. 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. In an effort to compact prosecution, the limitation “that can be” in line 3 will be interpreted as –configured to be--, and the limitation “can be” in line 21 will be interpreted as –configured to be--.
Claim 1 recites the limitation “its circumference” in line 13 which renders the claim indefinite. The part that “its” refers to is unclear as it could mean the casing wall or the first adapter component. In an effort to compact prosecution, the limitation will be interpreted as –a circumference of the casing wall--.
Claim 1 recites “has a hollow” in line 13 which renders the claim indefinite. The subject of the line is unclear as it could refer to the casing wall or bottle or adapter component. In an effort to compact prosecution, the limitation will be interpreted as –the first adapter component having--.
Claim 1 recites the limitation "the bottle neck" in line 21. There is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution, the limitation will be interpreted as –a bottle neck--.
Claim 1 recites the limitation "the holding element" in line 22. There is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution, the limitation will be interpreted as –the holding section--.
Claim 4 recites the limitation “wherein the second adapter component, preferably its outer hollow-cylindrical section, when it is in a position in which it” in line 2 renders the claim indefinite. The part that “it” refers to is unclear and it is unclear whether the limitation(s) following the term “preferably” are part of the claimed invention. 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. In an effort to compact prosecution, the limitation will be interpreted as –wherein when the second adapter component is in a position that--.
Claim 4 recites the limitation “preferably with respect” which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. 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. In an effort to compact prosecution, the limitations following preferably are interpreted as not part of the claimed features.
Claim 5 recites the limitation “sealing, with an in particular hollow-cylindrical geometry, which preferably is embodied as an insert.” which contains the limitation “in particular” and “preferably”. These two terms render the claim indefinite because it is unclear whether the limitation(s) following the terms are part of the claimed invention. 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. In an effort to compact prosecution, the limitations following “in particular” and “preferably” are interpreted as not part of the claimed features.
Claim 5 recites the limitation “which preferably is embodied as an axially extending bendable tongue element with a latching projection (322, 324, 423, 425) at its end side, with the latching projection extending in the direction of the longitudinal axis of the second adapter component (214, 414) or of the transfer device (200, 400), and preferably engaging in latching depressions (310, 312), bordered by tooth-like projections, of the first adapter component (212, 412).” In line 3. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language following “preferably” is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In an effort to compact prosecution, the limitation is interpreted as –wherein the at least one first latching element comprises an axially extending bendable tongue element with a latching projection at an end side of the tongue element, with the latching projection extending in the direction of the longitudinal axis of the second adapter component or of the transfer device, and further the latching projections engage latching depressions bordered by tooth-like projections of the first adapter component.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In an effort to compact prosecution, the limitation “such as a circumferential annular projection” is interpreted as not part of the claimed invention.
Regarding claim 9, the limitation “the inner hollow-cylindrical section of the second adapter component at its end” renders the claim indefinite. There is insufficient antecedent basis for the limitation “the inner hollow-cylindrical section” in the claim. Further the term “its” renders the claim indefinite since it is unclear what the term is referring to. In an effort to compact prosecution, the limitation in question is interpreted as -- an end of an inner hollow-cylindrical section of the second adapter component--.
Regarding claim 11, the limitation “the penetrating direction of the puncture needle” renders the claim indefinite. There is insufficient antecedent basis for the limitation. In an effort to compact prosecution, the limitation is interpreted as –a penetrating direction of the delivery element—
Regarding claim 12, the limitation “the sealing element” renders the claim indefinite. There is insufficient antecedent basis for the limitation. In an effort to compact prosecution, the limitation is interpreted as –a sealing element--
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-8, 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 20090036861) in view of Fukuoka (US 5364386) and further in view of Yokoyama (US 2011/0218511).
Regarding claim 1, Moy discloses a transfer device comprising a first adapter component (476, 416, 438, figure 9) configured to be positioned on the bottle (412, figure 9), a second adapter component (418, figure 9) which interacts with the first adapter component, is moveable in the longitudinal direction of the bottle (figure 9-12) and comprises a delivery element (484), wherein after moving the second adapter component along the first adapter component in the direction towards the closure and locking the second adapter component ([0056]), the first adapter component is secured in position non-detachably at the bottle or around the bottle (figures 9-12, [0056]), and
wherein the first adapter comprises a casing wall (416, figure 9) which surrounds the bottle along a circumference of the first casing wall ([0032]), the first adapter component having a hollow-cylindrical geometry (figure 9, [0032]) with a front edge (edge adjacent second adapter) extending on the bottle closure (428) side, a bottom section (476) that covers the bottom of the bottle at least in sections (figure 9), as well as a holding section (438) in the form of a ring element (interior ring of 450 and 451) that is situated on the front-edge side along the casing wall (figure 9-12), from which originate tongue- or ledge-like position securing elements (450, 451) which extend in the direction of and are inclined relative to the longitudinal axis of the first adapter component (figure 9-12), whereby when the bottle is positioned on the first adapter component, the position securing elements are supported or configured to be supported at the bottle (figures 9-12, [0038]).
Moy does not disclose the delivery element for piercing the closure and wherein the tongue-shaped elements originate from the holding portion and are in contact with the cylindrical body of the bottle.
Fukuoka discloses an infusion unit relatively pertinent to a problem posed by Applicant of transferring fluids between containers and teaches a delivery element (48, figure 2) for piercing closure (3).
Fukuoka utilizes the piercing delivery element for accessing the contents of the bottle (col 3, lines 45-48). It would have been obvious to a person of ordinary skill in the art at the effective filling date of the invention to substitute Moy with the piercing element of Fukuoka in order to access the contents of the bottle since the actuator element (484) achieves the same function of giving access to the interior of the bottle.
Moy and Fukuoka do not teach wherein the tongue-shaped elements originate from the holding portion and are in contact with the cylindrical body of the bottle.
Yokoyama discloses a connector in the same field of endeavor as the Applicant. Yokoyama teaches a bottle (100) wherein the tongue-shaped elements (111) originate from the holding portion (112) and are in contact with the cylindrical body of the bottle (figure 2).
Yokoyama provides engaging pieces in order to further prevent the containers from being dismounted unwillingly ([0065]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Moy and Fukuoka to further include a tongue shaped element to further prevent the containers from being dismounted.
Regarding claim 2, Moy discloses wherein, when the transfer device is secured in position at or around the bottle (figures 9-12), the first and the second adapter components form a surrounding sealed envelope that surrounds the bottle at least in the area of the closure element (figures 9-12, [0052])
Regarding claim 3, Moy discloses wherein the interior cross-section of the hollow-cylindrical section of the second adapter component corresponds to the exterior cross-section of the casing wall so as to guide the first adapter component during the latter's axial displacement (figures 9-12, the interior cross section contains the tabs 522 that slide along the casing wall of the first element during displacement).
Regarding claim 4, Moy discloses wherein when the second adapter component is in a position that surrounds the first adapter component the second adapter component is sealed with respect to the first adapter component ([0052]).
Regarding claim 5, Moy discloses wherein the second adapter component or the hollow-cylindrical section of the second adapter component comprise on the inside a sealing element (576, [0052]) that effects sealing.
Regarding claim 6, Moy discloses wherein, from the second adapter component originates at least one first latching element (522, [0038]) wherein the at least one first latching element comprises an axially extending bendable tongue element (shaft of 522) with a latching projection (end of 522) at an end side of the tongue element, with the latching projection extending in the direction of the longitudinal axis of the second adapter component or of the transfer device (figure 9-12), and further the latching projections engage latching depressions (depression between 451 and 450, figure 11) bordered by tooth-like projections (450, 451) of the first adapter component.
Regarding claim 7, Moy discloses wherein from the casing wall of the first adapter component protrudes a limit stop (end of the casing wall adjacent the second adapter component, figure 12), with which, when the first and the second adapter components are properly connected, the latter is in contact with.
Regarding claim 8, Moy discloses wherein when the first and the second adapter components have been at least partially pushed into each other, they form a sealed container that surrounds the bottle (figure 12, [0059]).
Regarding claim 10, Moy discloses wherein, when the first and the second adapter components have been pushed into each other, they are inseparably connected during regular use ([0059]).
Regarding claim 11, Moy discloses wherein during an adjustment of the second adapter component in a direction, the first adapter component interacts with the second adapter component in such a manner, that an adjustment of the second adapter component relative to the first adapter component against the penetration direction is prevented ([0059]).
Moy does not disclose the delivery element is a needle puncturing in the puncturing direction.
Fukuoka discloses an infusion unit relatively pertinent to a problem posed by Applicant of transferring fluids between containers and teaches a delivery element as a needle (48, figure 2) for piercing closure (3).
Fukuoka utilizes the piercing delivery element for accessing the contents of the bottle (col 3, lines 45-48). It would have been obvious to a person of ordinary skill in the art at the effective filling date of the invention to substitute Moy with the piercing element of Fukuoka in order to access the contents of the bottle since the actuator element (484) achieves the same function of giving access to the interior of the bottle.
Regarding claim 12, Moy discloses wherein the second adapter component possesses a hood- or cup-shaped geometry (418, figure 9, shaped as a hood or cup) with a cylindrical circumferential wall (492) and, extending coaxial to the latter, an inner hollow-cylindrical section (area interior to 496, section 576), from which originates a sealing element (576, 511) which, when the first and the second adapter components have been assembled, seals the second adapter component against the first adapter component ([0052]).
Regarding claim 13, Moy discloses wherein the sealing element possesses a U-shaped geometry (figure 9, shaped as U) with a non-isosceles cross-section (circular cross section), with an inner (511) and an outer leg (576), in between which extends in sections the inner hollow-cylindrical section (figure 9).
Regarding claim 14, Moy discloses wherein the tongue elements (522, 520) span a cylindrical envelope (figure 3) that extends coaxially relative to the circumferential wall of the second adapter component (figures 9-12) and starting from the annular element (524) extend in the direction of the bottom wall (499) of the second adapter component (figures 9-12).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Moy in view of Fukuoka and further in view of Yokoyama further in view of Holt (US 2012/0296307).
Regarding claim 9, Moy does not teach wherein an end of an inner hollow-cylindrical section of the second adapter component comprises at least one inward directed projection which, when the adapter components have been properly connected, engages behind the collar-like rim of the bottle.
Holt discloses vial adapters in the same field of endeavor as the Applicant. Holt teaches a vial adapter (figure 21) with an end (end wall of 916) of an inner hollow-cylindrical section (interior surface of wall 916) of the second adapter component comprises at least one inward directed projection (940, [0172]) which, when the adapter components have been properly connected, engages behind the collar-like rim (918) of the bottle (figure 22).
Holt provides the projections to prevent separation of the adapter from bottle ([0172]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Moy with the projections of Holt to further prevent separation of the adapter from bottle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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