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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/17/2026 has been entered.
Response to Amendment
The Amendment filed on 3/19/2026 has been entered. Claims 1-2 and 7-19 remain pending in the application. Claims 20-22 are new.
Applicants’ amendments to the claims have failed to overcome all of the rejections under 35 USC 112 previously set forth in the Final Office Action mailed 1/22/2026. Specifically, the rejection under 35 U.S.C. 112 of claim 2 has not been overcome.
It is noted that in claim 2, line 4 of the claims filed 3/19/2026, the term “proximal” appears with a strikethrough. However, in the amendment filed 10/21/2025 the term “proximal” in line 4 was deleted. Since the term proximal was already deleted in the amendment filed 10/21/2025, it should not appear with a strikethrough in claim 2 of the claims filed 3/19/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 2 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.
In regard to claim 2,
Line 4 recites “the distal end”. It is unclear if the distal end of line 4 refers to the distal end of the first holder or the distal end of the second holder. For examination purposes Examiner construes the distal end to be the distal end of the first holder. As suggested in the Final Office Action mailed 1/22/2026, Examiner suggests replacing “the distal end” in line 4 of claim 2 with “the distal end of the first holder”.
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 (i.e., changing from AIA to pre-AIA ) 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 1-2, 7-11, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Avery (U.S. PG publication 20130090602).
In regard to claim 1,
A first embodiment of Avery discloses a collection of two or more dose delivery mechanisms (two or more dose setting mechanism, which are construed as the two or more dose delivery mechanisms, are provided as supported by paragraph [0014], with each dose delivery mechanism being capable of connection to a respective medicament container holder as supported by paragraph [0082]; see also paragraph [0014] and [0119]; Examiner notes each of the dose setting members function to deliver a dose as supported by paragraph [0093]; figure 13 shows an example dose delivery mechanism labeled below) and two or more holders (the cartridge holders, which can each hold a medicament container, make up different cartridge assemblies as described in paragraph [0025] and [0048]. The cartridge holders are construed as the two or more holders. A respective cartridge holder can be connected to a respective one of the two or more dose delivery mechanisms via threads; Examiner notes figure 13 shows an example medicament container holder labeled below; see also paragraph [0082]; paragraph [0119]) comprising:
[AltContent: arrow][AltContent: textbox (Dose delivery mechanism)][AltContent: textbox (Medicament container holder)][AltContent: arrow]
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a first dose delivery mechanism (first dose delivery mechanism with a thread as described in paragraph [0014], [0048], and [0119], see figure 13) having a proximal end (end closest to the injection site) comprising a first keyed connector (thread; paragraph [0048] and [0119], see figure 13);
a second dose delivery mechanism (second dose delivery mechanism with a thread as described in paragraph [0014], [0048], and [0119]) having a proximal end (end closest to the injection site) comprising a second keyed connector (different thread from the thread of the first dose delivery member; paragraph [0048] and [0119]);
a first holder (first holder of the cartridge assembly which has a complimentary thread to the first dose delivery mechanism; see figure 13; paragraph [0014], [0048], and [0119]) configured to accept and hold a first medicament container containing a first medicament (paragraph [0025] and [0014]; Examiner notes the first medicament is not positively required by the claim), a distal end (end furthest from the injection site which mates with the first dose delivery mechanism and comprises the complementary thread to the first dose delivery mechanism) of the first holder comprising a third keyed connector (complementary thread to the first dose delivery mechanism; paragraph [0014], [0048], and [0119]); and
a second holder (second holder of the cartridge assembly which has a complimentary thread to the second dose delivery mechanism; paragraph [0014], [0048], and [0119]) configured to accept and hold a second medicament container containing a second medicament (paragraph [0025] and [0014]; Examiner notes the second medicament is not positively required by the claim), where a distal end (end furthest from the injection site which mates with the second dose delivery mechanism and comprises the complementary thread to the second dose delivery mechanism) of the second holder comprises a fourth keyed connector (complementary thread to the second dose delivery mechanism; paragraph [0014], [0048], and [0119]) and the second medicament is different than the first medicament (paragraph [0014] and [0119]),
the first keyed connector is not capable of forming a connection with the fourth keyed connector and the second keyed connector is not capable of forming a connection with the third keyed connector (paragraph [0008] and [0020]), and
the first keyed connector is configured to engage and form a connection with the third keyed connector and the second keyed connector is configured to engage and form a connection with the fourth keyed connector (paragraph [0014], [0024], and [0048]),
the first and second keyed connectors each comprising a thread form (see analysis above and figure 13; see also paragraph [0048] and [0119]), and each of the thread forms differing (paragraph [0062]; Examiner notes different angled/pitched thread forms for example would result in the thread forms having different geometries. See also paragraph [0048] and [0119]).
The first embodiment of Avery is silent as to each of the thread forms having a same core diameter and each of the thread forms differing in outer thread diameter or thread width.
A second embodiment of Avery teaches each of the first keyed connector (figure 4A, item 408) and the second keyed connector (figure 4A, item 402) differing in outer diameter or width (see figure 4A where item 402 has a smaller outer diameter than item 408; see also paragraph [0034]-[0035], and [0102]-[0105]; Examiner notes paragraph [0104] and [0035] supports that the shape can vary in any plane and the axial extent can also vary i.e. the width can also be varied).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first keyed connector which comprises a thread form of the first embodiment of Avery and the second keyed connector which comprises a thread form of the first embodiment of Avery to include each of the first keyed connector and the second keyed connector differing in outer diameter or width and to modify the third keyed connector and the fourth keyed connector accordingly, as taught by the second embodiment of Avery, therefore resulting in each of the thread forms differing in outer thread diameter or thread width for the purpose of increasing user safety (paragraph [0009] of Avery) and as Avery supports the size and shape of a coding feature/keyed connector can be varied in a variety of ways to equivalently prevent connection/use of an incorrect medicament (paragraph [0020], [0031]-[0039] of Avery).
The first embodiment of Avery in view of the second embodiment of Avery is silent as to each of the thread forms having a same core diameter.
It would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include each of the thread forms having a same core diameter since applicant has not disclosed that having each of the thread forms having a same core diameter solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of each of the thread forms having a same core diameter, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Additionally, it would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include each of the thread forms having a same core diameter since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed thread form and a thread form having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Examiner notes modifying each of the thread forms to have a same core diameter would still result in the appropriate cartridge assembly (a holder of the two or more holders) being able to be connected to an appropriate dose setting member (a dose delivery mechanism of the two or more dose delivery mechanisms) in Avery.
In regard to claim 2,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 1, wherein the distal end of each of the first and second holders is an open distal end (end which enables a cartridge to be placed within the holder, see figure 1; paragraph [0086]) configured to enable axial movement of a piston rod contained within one of the first or second dose delivery mechanisms (Examiner notes a piston rod is not positively required by claim 2 and “configured to enable axial movement of a piston rod contained within one of the first or second dose delivery mechanisms” is a functional limitation. A piston rod is fully capable of being contained within one of the first or second dose delivery mechanisms to interact with the stopper as supported by paragraph [0086] and figure 1) such that the piston rod is configured to move beyond the distal end into the first holder when the first holder is attached to the first dose delivery mechanism (As noted above the piston rod is not positively required by the claim and “configured to move beyond the distal end into the first holder when the first holder is attached to the first dose delivery mechanism” is a functional limitation. A piston rod is fully capable of moving beyond the distal end into the first holder when the first holder is attached to the first dose delivery mechanism during dose delivery as supported by paragraph [0086]).
In regard to claim 7,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 1, wherein the thread form of the first keyed connector has a first pitch and the thread form of the second keyed connector has a second pitch (see analysis of claim 1 above and paragraph [0048], [0062], [0119], [0011], and [0036]-[0039]).
In regard to claim 8,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 7, wherein the first pitch and the second pitch are different (paragraph [0119], [0062],[0011], and [0036]-[0039]).
In regard to claim 9,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 1, wherein the thread form of the first keyed connector has a first thread width and the thread form of the second keyed connector has a second width (see analysis of claim 1 above).
In regard to claim 10,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 1, wherein the thread form of the first keyed connector has a first thread geometry and the thread form of the second keyed connector has a second geometry (see analysis of claim 1 above and paragraph [0048], [0062] and [0119]).
In regard to claim 11,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 10, wherein the first thread geometry is different than the second geometry (see analysis of claim 1 above and paragraph [0048], [0062] and [0119]).
In regard to claim 17,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 1, wherein the thread form of each of the first and second keyed connectors is a female thread form (see analysis of claim 1 above and figure 13).
In regard to claim 18,
The first embodiment of Avery discloses a collection of two or more dose delivery mechanisms (two or more dose setting mechanism, which are construed as the two or more dose delivery mechanisms, are provided as supported by paragraph [0014], with each dose delivery mechanism being capable of connection to a respective medicament container holder as supported by paragraph [0082] and figure 1; see also paragraph [0014] and [0119]; Examiner notes each of the dose setting members function to deliver a dose as supported by paragraph [0093]; figure 13 shows an example dose delivery mechanism labeled below) comprising:
[AltContent: textbox (Medicament container holder)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Dose delivery mechanism)]
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a first dose delivery mechanism (first dose delivery mechanism with a thread as described in paragraph [0014], [0048], and [0119], see figure 13) having a proximal end (end closest to the injection site) comprising a first keyed connector (thread; paragraph [0048] and [0119], see figure 13); and
a second dose delivery mechanism (second dose delivery mechanism with a thread as described in paragraph [0014], [0048], and [0119]) having a proximal end (end closest to the injection site) comprising a second keyed connector (different thread from the thread of the first dose delivery member; paragraph [0048] and [0119]),
each of the first keyed connector and the second keyed connector comprising a thread form (see analysis above and figure 13; see also paragraph [0048] and [0119]), each of the thread forms are different (paragraph [0062]; Examiner notes different angled/pitched thread forms for example would result in the thread forms having different geometries. See also paragraph [0048] and [0119]).
The first embodiment of Avery is silent as to each of the thread forms having a same core diameter and each of the thread forms having different outer thread diameters or different thread widths.
The second embodiment of Avery teaches each of the first keyed connector (figure 4A, item 408) and the second keyed connector (figure 4A, item 402) having different outer diameters or widths (see figure 4A where item 402 has a smaller outer diameter than item 408; see also paragraph [0034]-[0035], and [0102]-[0105]; Examiner notes paragraph [0104] and [0035] supports that the shape can vary in any plane and the axial extent can also vary i.e. the width can also be varied).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first keyed connector which comprises a thread form of the first embodiment of Avery and the second keyed connector which comprises a thread form of the first embodiment of Avery to include each of the first keyed connector and the second keyed connector having different outer thread diameters or different thread widths, as taught by the second embodiment of Avery, therefore resulting in each of the thread forms having different outer thread diameters or different thread widths for the purpose of increasing user safety (paragraph [0009] of Avery) and as Avery supports the size and shape of a coding feature/keyed connector can be varied in a variety of ways to equivalently prevent connection/use of an incorrect medicament (paragraph [0020], [0031]-[0039] of Avery).
The first embodiment of Avery in view of the second embodiment of Avery is silent as to each of the thread forms having a same core diameter.
It would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include each of the thread forms having a same core diameter since applicant has not disclosed that having each of the thread forms having a same core diameter solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of each of the thread forms having a same core diameter, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Additionally, it would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include each of the thread forms having a same core diameter since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed thread form and a thread form having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Examiner notes modifying each of the thread forms to have a same core diameter would still result in the appropriate cartridge assembly (a holder of two or more container holders) being able to be connected to an appropriate dose setting member (a dose delivery mechanism of the two or more dose delivery mechanisms) in Avery.
In regard to claim 19,
The first embodiment of Avery discloses a collection of two or more medicament container holders (cartridge holders, which can hold a medicament container, make up different cartridge assemblies as described in paragraph [0025] and [0048]. The cartridge holders are construed as the two or more medicament container holders. A respective cartridge holder can be connected to a respective dose setting mechanism of Avery via threads; Examiner notes figure 13 shows an example medicament container holder labeled below; see also paragraph [0082]; paragraph [0119]) comprising:
[AltContent: textbox (Dose setting mechanism)][AltContent: arrow][AltContent: textbox (Medicament container holder)][AltContent: arrow]
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a first holder (first holder of the cartridge assembly which has a complimentary thread to a first dose setting mechanism; see figure 13; paragraph [0014], [0048], and [0119]) configured to accept and hold a first medicament container containing a first medicament (paragraph [0025] and [0014]; Examiner notes the first medicament and first medicament container are not positively required by the claim), a distal end (end furthest from the injection site which mates with the first dose setting mechanism and comprises the complementary thread to the first dose setting mechanism) of the first holder comprising a first keyed connector (complementary thread to the first dose setting mechanism; paragraph [0014], [0048], and [0119]);
a second holder (second holder of the cartridge assembly which has a complimentary thread to a second dose setting mechanism; paragraph [0014], [0048], and [0119]) configured to accept and hold a second medicament container containing a second medicament (paragraph [0025] and [0014]; Examiner notes the second medicament and second medicament container are not positively required by the claim), a distal end (end furthest from the injection site which mates with the second dose setting mechanism and comprises the complementary thread to the second dose setting mechanism) of the second holder comprising a second keyed connector (complementary thread to the second dose setting mechanism; paragraph [0014], [0048], and [0119]) and the second medicament is different than the first medicament (paragraph [0014] and [0119]),
each of the first keyed connector and the second keyed connector comprise a thread form (see analysis above and figure 13; see also paragraph [0048] and [0119]), and each of the thread forms are different (different thread geometries; paragraph [0062]; Examiner notes different angled/pitched thread forms for example would result in the thread forms having different geometries. See also paragraph [0048] and [0119]).
The first embodiment of Avery is silent as to each of the thread forms have a same core diameter, and each of the thread forms have different outer thread diameters or different thread widths.
The second embodiment of Avery teaches each of the first keyed connector (figure 4A, item 408) and the second keyed connector (figure 4A, item 402) have different outer diameters or widths (see figure 4A where item 402 has a smaller outer diameter than item 408; see also paragraph [0034]-[0035], and [0102]-[0105]; Examiner notes paragraph [0104] and [0035] supports that the shape can vary in any plane and the axial extent can also vary i.e. the width can also be varied).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first keyed connector which comprises a thread form of the first embodiment of Avery and the second keyed connector which comprises a thread form of the first embodiment of Avery to include each of the first keyed connector and the second keyed connector have different outer thread diameters or different thread widths, as taught by the second embodiment of Avery, therefore resulting in each of the thread forms have different outer thread diameters or different thread widths for the purpose of increasing user safety (paragraph [0009] of Avery) and as Avery supports the size and shape of a coding feature/keyed connector can be varied in a variety of ways to equivalently prevent connection/use of an incorrect medicament (paragraph [0020], [0031]-[0039] of Avery).
The first embodiment of Avery in view of the second embodiment of Avery is silent as to each of the thread forms have a same core diameter.
It would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include each of the thread forms have a same core diameter since applicant has not disclosed that having each of the thread forms have a same core diameter solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of each of the thread forms have a same core diameter, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Additionally, it would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include each of the thread forms have a same core diameter since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed thread form and a thread form having the claimed relative dimensions would not perform differently than the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Examiner notes modifying each of the thread forms to have a same core diameter would still result in the appropriate cartridge assembly (a holder of two or more container holders) being able to be connected to an appropriate dose setting member in Avery.
In regard to claim 20,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 1, wherein the outer thread diameter of the first keyed connector is larger than the outer thread diameter of the second keyed connector (see analysis of claim 1 above and figure 4A wherein the outer diameter of item 408 is larger than item 402) and the thread width of the first keyed connector is different than the thread width of the second keyed connector (see analysis of claim 1 above wherein the shape of the coding feature/keyed connector can vary in any plane and the axial extent can also vary i.e. the width can be different).
The first embodiment of Avery in view of the second embodiment of Avery is silent as to the thread width of the first keyed connector is smaller than the thread width of the second keyed connector.
It would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include the thread width of the first keyed connector is smaller than the thread width of the second keyed connector since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed thread form and a thread form having the claimed relative dimensions would not perform differently than the prior art device. As noted above, Avery supports the width of the first keyed connector can be different than the width of the second keyed connector and the size and shape of a coding feature/keyed connector can be varied in a variety of ways to equivalently prevent connection/use of an incorrect medicament (paragraph [0020], [0031]-[0039] of Avery).
In regard to claim 21,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 18, wherein the outer thread diameter of the first keyed connector is larger than the outer thread diameter of the second keyed connector (see analysis of claim 1 above and figure 4A wherein the outer diameter of item 408 is larger than item 402) and the thread width of the first keyed connector is different than the thread width of the second keyed connector (see analysis of claim 1 above wherein the shape of the coding feature/keyed connector can vary in any plane and the axial extent can also vary i.e. the width can be different).
The first embodiment of Avery in view of the second embodiment of Avery is silent as the thread width of the first keyed connector is smaller than the thread width of the second keyed connector.
It would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include the thread width of the first keyed connector is smaller than the thread width of the second keyed connector since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed thread form and a thread form having the claimed relative dimensions would not perform differently than the prior art device. As noted above, Avery supports the width of the first keyed connector can be different than the width of the second keyed connector and the size and shape of a coding feature/keyed connector can be varied in a variety of ways to equivalently prevent connection/use of an incorrect medicament (paragraph [0020], [0031]-[0039] of Avery).
In regard to claim 22,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 19, wherein the outer thread diameter of the first keyed connector is larger than the outer thread diameter of the second keyed connector (see analysis of claim 1 above and figure 4A wherein the outer diameter of item 408 is larger than item 402) and the thread width of the first keyed connector is different than the thread width of the second keyed connector (see analysis of claim 1 above wherein the shape of the coding feature/keyed connector can vary in any plane and the axial extent can also vary i.e. the width can be different).
The first embodiment of Avery in view of the second embodiment of Avery is silent as the thread width of the first keyed connector is smaller than the thread width of the second keyed connector.
It would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery to include the thread width of the first keyed connector is smaller than the thread width of the second keyed connector since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed thread form and a thread form having the claimed relative dimensions would not perform differently than the prior art device. As noted above, Avery supports the width of the first keyed connector can be different than the width of the second keyed connector and the size and shape of a coding feature/keyed connector can be varied in a variety of ways to equivalently prevent connection/use of an incorrect medicament (paragraph [0020], [0031]-[0039] of Avery).
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Avery (U.S. PG publication 20130090602) further in view of Bitdinger (U.S. PG publication 20030109834).
In regard to claim 12,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 1, wherein the thread form of each of the first and second keyed connectors is a female thread form (see figure 13) having the same core diameter (see analysis of claim 1 above. As modified above, each thread form has the same core diameter) and different outer diameters (see analysis of claim 1 above).
The first embodiment of Avery in view of the second embodiment of Avery fails to disclose wherein the thread form of each of the first and second keyed connectors is a male thread form.
Bitdinger teaches that a female thread form or male thread form could be used to attach a dose delivery mechanism to a holder to achieve the same result (paragraph [0039]) and thus a female thread form or male thread form were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a male thread form in place of a female thread form of the first dose delivery mechanism, to substitute a male thread form, different from the male thread form of the first dose delivery mechanism, in place of a female thread form of the second dose delivery mechanism, to substitute a female thread form complementary to the thread form of the first dose delivery mechanism in place of a male thread form of the first holder and to substitute a female thread form complementary to the thread form of the second dose delivery mechanism in place of a male thread form of the second holder since it has been held that substituting parts of an invention involves only routine skill in the art. Additionally, it has been held that a mere reversal of the essential working parts (i.e. replacing male thread forms with female thread forms and female thread forms with male thread forms) of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167. The resulting male thread forms would have different outer diameters as supported by the first embodiment of Avery in view of the second embodiment of Avery.
In regard to claim 13,
The first embodiment of Avery in view of the second embodiment of Avery in view of Bitdinger teaches the collection of claim 12, wherein each male thread form have a different geometry (see analysis of claim 1 and 12 above and paragraph [0048], [0062] and [0119] of Avery).
In regard to claim 14,
The first embodiment of Avery in view of the second embodiment of Avery in view of Bitdinger teaches the collection of claim 12, wherein each male thread form have a different pitch (see analysis of claim 1 and 12 above and paragraph [0048], [0036]-[0039], [0011], [0062] and [0119] of Avery).
In regard to claim 15,
The first embodiment of Avery in view of the second embodiment of Avery in view of Bitdinger teaches the collection of claim 12.
The first embodiment of Avery in view of the second embodiment of Avery in view of Bitdinger is silent as to wherein the male thread form of the first keyed connector has a hand opposite that of the male thread form of the second keyed connector.
It would have been an obvious matter of design choice to modify the first embodiment of Avery in view of the second embodiment of Avery in view of Bitdinger to include wherein the male thread form of the first keyed connector has a hand opposite that of the male thread form of the second keyed connector since applicant has not disclosed that having wherein the male thread form of the first keyed connector has a hand opposite that of the male thread form of the second keyed connector solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the male thread form of the first keyed connector has a hand opposite that of the male thread form of the second keyed connector, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Examiner notes the first holder and second holder would be modified accordingly. Paragraph [0119] and [0062] of Avery also supports the turns and angle in the thread forms can be modified.
In regard to claim 16,
The first embodiment of Avery in view of the second embodiment of Avery teaches the collection of claim 1, wherein the thread form of each of the first and second keyed connectors is a female thread form (see analysis of claim 1 above and figure 13).
The first embodiment of Avery in view of the second embodiment of Avery fails to disclose wherein the thread form of each of the first and second keyed connectors is a male thread form.
Bitdinger teaches that a female thread form or male thread form could be used to attach a dose delivery mechanism to a holder to achieve the same result (paragraph [0039]) and thus a female thread form or male thread form were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a male thread form in place of a female thread form of the first dose delivery mechanism, to substitute a male thread form, different from the male thread form of the first dose delivery mechanism, in place of a female thread form of the second dose delivery mechanism, to substitute a female thread form complementary to the thread form of the first dose delivery mechanism in place of a male thread form of the first holder and to substitute a female thread form complementary to the thread form of the second dose delivery mechanism in place of a male thread form of the second holder since it has been held that substituting parts of an invention involves only routine skill in the art. Additionally, it has been held that a mere reversal of the essential working parts (i.e. replacing male thread forms with female thread forms and female thread forms with male thread forms) of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Response to Arguments
Applicant's arguments filed 3/19/2026 have been fully considered but they are not persuasive.
Applicant argues in regard to the rejection under 35 U.S.C. 112 that the claims have been amended as suggested by the Examiner. As noted above, claim 2 was not fully amended as suggested by the Examiner. Examiner suggests replacing “the distal end” in line 4 of claim 2 with “the distal end of the first holder” in order to overcome the remaining rejection under 35 U.S.C. 112.
Applicant argues that paragraph [0048] and [0119] of Avery do not teach a first thread width and a second thread width as previously required in claim 9. As noted in the advisory action mailed 3/30/2026, the first thread width was not required to be different than the second thread width in claim 9. As detailed above, claim 1 has been rejected over the first embodiment of Avery in view of the second embodiment of Avery. The second embodiment of Avery teaches each of the first keyed connector (figure 4A, item 408) and the second keyed connector (figure 4A, item 402) having different outer diameters or widths (see figure 4A where item 402 has a smaller outer diameter than item 408; see also paragraph [0034]-[0035], and [0102]-[0105]; Examiner notes paragraph [0104] and [0035] supports that the shape can vary in any plane and the axial extent can also vary i.e. the width can also be varied). Further, Avery supports the size and shape of a coding feature/keyed connector can be varied in a variety of ways (width, diameter, shape, and/or geometry) to equivalently prevent connection/use of an incorrect medicament (paragraph [0020], [0031]-[0039] of Avery). Avery also supports a variety of different coding feature/keyed connectors that can be equivalently used such as a pin and ridge, a pin and a pin, a ridge and a pair of pins, a pin and groove, and a screw thread (see paragraph [0013]). The Examiner is not relying on paragraph [0119] of Avery to specifically teach each of the thread forms differing in outer thread diameter or thread width. Therefore, Applicant’s arguments are not found to be persuasive.
Applicant argues that Avery does not disclose each of the thread forms having a same core diameter. As noted in the rejection of claim 1 above, the Examiner is not relying on Avery to teach each of the thread forms having a same core diameter. Therefore, Applicant’s arguments are not found to be persuasive.
Applicant argues claims 2 and 7-17 are allowable as they depend from independent claim 1. As claim 1 is not currently allowable for reasons detailed above, claims 2 and 7-17 are not allowable based on their dependence on claim 1.
Applicant argues that claims 18-19 are allowable for similar reasons as claim 1. See response to arguments in regard to claim 1 above.
Applicant argues that new claims 20-22 are allowable since they are dependent from claim 1. It is noted that claim 20 is dependent from claim 1, claim 21 is dependent from claim 18, and claim 22 is dependent from claim 19. As claim 1, 18, and 19 have not been found allowable, claims 20-22 are not allowable based on their dependence. No other arguments in regard to claims 20-22 have been provided. As detailed above, the prior art of record does teach the limitations of claims 20-22.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Nelson (U.S. patent no 5875976) discloses a thread form having different outer thread width (see figure 7 wherein the thread form has different outer thread widths. It is noted that claims 1 and 18-19 do not require the thread forms to have different outer thread widths from each other).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/LAURA A BOUCHELLE/ Primary Examiner, Art Unit 3783
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