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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on 3/30/26 is acknowledged. Claims 20-24 are withdrawn from consideration.
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.
Claim 11, 12, 13, and 16-19 is 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 11, the phrase “the central plane of the mixing pin” lacks antecedent basis. The only central plane previously recited is that of the body in parent claim 1.
Regarding claim 12, it is unclear what is meant by a “lateral axis” of the adapter body or how such an axis should be defined by the body, and “the same side of a lateral axis of the adapter body” lacks antecedent basis. For the purposes of examination, the claim will be interpreted to at least encompass positioning relative to a line or plane that is perpendicular to the longitudinal axis of the body.
Regarding claim 13, it is unclear what is meant by a “lateral axis” similarly to claim 12 above, and will be similarly interpreted for the purposes of examination.
Regarding claim 16, “forms by at least one channel” is grammatically unclear to the point of being indefinite. For the purposes of examination, the limitation will be interpreted to at least encompass the mixing pin itself comprising a channel or the mixing pin in combination with other elements together forming a channel.
Claims 17-19 are rejected as dependent from claim 16.
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.
Claim(s) 1-7, 10-13, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greter et al. (US 20150190770).
Regarding claim 1, Greter et al. discloses an adapter (structure of fig. 6-7) comprising: a body (see fig. 6-7) comprising: a first port (one of ports 54) configured to connect with a first container 21 to receive a first substance (see fig. 6), a first channel (proximal portion of one of channels 55 connected with the port 54 cited as the first port above) in communication with the first port (see fig. 6), a second port (the other of ports 54) configured to connect with a second container 22 to receive a second substance (see fig. 6), a second channel (proximal portion of the other of channels 55 connected with the port 54 cited as the second port above) in communication with the second port (see fig. 6), a third port 315 configured to connect with a recipient container to output a mixture of the first substance and the second substance (see fig. 7, fully capable of connecting with a recipient container), a mixing chamber (interior of 317 and 56, see fig. 7) having a first portion in communication with the first port and the second port and a second portion in communication with the third port (distal portions of channels 55 visible in fig. 7); and a mixing pin 32 inserted into the mixing chamber (see fig. 6-7), wherein at least one of the first channel and the second channel is oriented offset of a central plane of the body (see fig. 6; for example, relative to a central plane through the body oriented perpendicular to the plane of viewing illustrated in fig. 6-7).
Regarding claim 2, Greter et al. discloses the body further comprises an opening in the first portion of the mixing chamber configured to receive the mixing pin (proximal opening of 316).
Regarding claim 3, Greter et al. discloses the mixing pin is removable from the mixing chamber (through the proximal opening of 316).
Regarding claim 4, Greter et al. discloses the mixing pin has an end cap (end surfaces of either end of 32), and the body has a rim configured to engage the end cap (rim-shaped surfaces on either end of 32 in fig. 7 that engage and hold it in place axially).
Regarding claim 5, Greter et al. discloses a sealing member 23 configured to seal the first portion of the mixing chamber (see fig. 6).
Regarding claim 6, Greter et al. discloses the first port and/or the second port are substantially parallel to the mixing chamber (see fig. 6).
Regarding claim 7, Greter et al. discloses the first channel extends at a first angle relative to the mixing chamber, and the second channel extends at a second angle relative to the mixing chamber (see fig. 6, both extend either 90 degrees or 180 degrees depending on the channel portion).
Regarding claim 10, Greter et al. discloses a first plug in an end of the first channel, and a second plug in an end of the second channel (element 23 in each channel, see fig. 6).
Regarding claim 11, as best understood, Greter et al. discloses the first channel and the second channel are offset of the central plane of the mixing pin (see fig. 6; for example, relative to a central plane through the body oriented perpendicular to the plane of viewing illustrated in fig. 6-7).
Regarding claim 12, as best understood, Greter et al. discloses the first channel and the second channel are on the same side of a lateral axis of the adapter body (see fig. 6; the lateral axis being defined as one that extends left-to-right in fig. 6, perpendicular to the body’s central longitudinal axis, below the position of the first and second channels as defined in claim 1).
Regarding claim 13, as best understood, Greter et al. discloses the first channel and the second channel are on opposite sides of a lateral axis of the adapter body (see fig. 6; alternatively, the lateral axis being defined as one that extends into/out of the plane of the image in fig. 6, perpendicular to the body’s central longitudinal axis, below the position of the first and second channels as defined in claim 1).
Regarding claim 16, as best understood, Greter et al. discloses the mixing pin forms by at least one channel (one or more of 321, 324, 325, 326).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8, 9, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greter et al. in view of Smith et al. (US 20190083745).
Regarding claim 8, Greter et al. discloses the adapter as claimed, except for speficially disclosing the first and/or second angle greater than 90 degrees. However, Smith et al. teaches providing channels 17 and 27, converging to a chamber 46 (see fig. 2), at obtuse angles relative to the central axis (see fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Greter et al. to utilize channels at angles greater than 90 degrees, as taught by Smith et al., in order to reduce the size of the apparatus for ease of use, and further since such a modification is a simple substitution of one known element for another to achieve predictable results (connecting fluid sources via channels to a shared chamber).
Regarding claim 9, Greter et al., as modified by Smith et al. above, teaches the claimed adapter, except for Smith et al. teaching one or both of the angles specifically falling specifically within the range of about 120 to about 160 degrees. However, there is no evidence of record that establishes that changing the angle would result in a difference in function of the Greter et al. in view of Smith et al. device. Further, a person having ordinary skill in the art, being faced with modifying the adapter of Greter et al. in view of Smith et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating only that the angle “may” be within “about” the claimed range (see par. 0009, 0015, 0070, 0089, 0094), and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of Greter et al. in view of Smith et al. to be between about 120 and about 160 degrees as an obvious matter of design choice within the skill of the art.
Regarding claim 15, Greter et al. disloses the adapter as claimed, including luer connectors for the ports (see fig. 6-7), except for specifically disclosing the first port is a female Luer connector, the second port is a female Luer connector, and the third port is a male Luer connector. However, Smith et al. teaches interchangeability of male and female luer connectors within a device (par. 0052). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the individual ports of Greter et al. to be different kinds of connectors, as taught by Smith et al., including an arrangement of the first two ports being male luer connectors and the third being a female luer connector as claimed, since Smith et al. teaches utilizing different ports for connection to appropriate types of devices being used with the adaptor (par. 0052), and further since choosing between male and female luer connectors for a port is an obvious matter of design choice resulting from a simple reversal of parts.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greter et al. in view of Kers (EP 0327519).
Regarding claim 14, Greter et al. discloses the adapter as claimed, except for specifically disclosing the first channel and the second channel are connected to the body at different longitudinal positions. However, Kers teaches connecting two channels to a converging chamber at different longitudinal positions (see fig. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the adapter of Greter et al. to have channels connecting to the body at different longitudinal positions, as taught by Kers, since such a modification is a simple substitution of one known arrangement of another to achieve a predictable result (in both relative positions the channels will connect to the central chamber), and further since choosing between relative positions of the channels relative to the chamber is an obvious matter of design choice resulting from a simple rearrangement of parts.
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greter et al.
Regarding claims 17 and 18, Greter et al. discloses the adapter as claimed, except for disclosing the at least one channel has a dimension of specifically about 200 to about 1000 micrometers, or about 400 to about 600 micrometers. However, there is no evidence of record that establishes that changing these ranges of “dimensions” would result in a difference in function of the Greter et al. device. Further, a person having ordinary skill in the art, being faced with modifying the adapter of Greter et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed “dimensions”. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating only that the dimension “may” be within “about” the claimed range and offering other scopes of ranges (see at least par. 0009, 0015, 0053, 0078, 0099), and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a “dimension” as claimed of Greter et al. to be within either of the claimed ranges as an obvious matter of design choice within the skill of the art.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greter et al. in view of Keller (US 8100295).
Regarding claim 19, Greter et al. discloses the adapter as claimed, except for disclosing the at least one channel specifically includes at least one helical channel. However, Keller teaches a mixing pin forming a helical channel (see fig. 18; col. 5, ln. 60-65).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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