DETAILED ACTION
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 1-15 are objected to because of the following informalities:
change claim 4 line 1 accordingly: “claim 3, further comprising”
change claim 13 lines 2-4 accordingly: “extending along [[a]] the second longitudinal axis (L2) between a proximal end and a distal end, the method comprising the steps of: inserting [[a]] the medicament container”
change claim 13 lines 7-9 accordingly: “with [[a]] the distal cover, wherein the distal cover comprises [[a]] the key slot perpendicular to the first longitudinal axis (L1); attaching [[a]] the key that”
change claim 14 line 3 accordingly: “selecting [[a]] the distal cover with [[a]] the key slot in”
change claim 15 line 3 accordingly: “selecting [[a]] the key with”
It is noted that claims 1-4 include reference numbers in parenthesis in the claims corresponding to the claimed elements and claims 5-15 are void of the reference characters in parenthesis. The claims should be changed so that (1) all claims include the corresponding reference characters in parenthesis or alternatively (2) none of the claims include the corresponding reference characters in parenthesis.
Appropriate correction is required.
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 1-15 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 distal end of the interior chamber" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the distal end of the interior chamber" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the plunger rod (2)" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the proximal direction" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites “the proximal direction of the distal body”. Applicant page 2, ll. 9-15 states “when the term ‘proximal direction’ is used, this refers to the direction pointing towards the dose delivery site during use of the medicament delivery device”. Thus the proximal direction appears to refer to all structures of the medicant delivery device. It is unclear what is meant by the proximal direction of the distal body.
Claim 10 recites the limitation "the circumferential direction" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the proximal engaging member" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the distal engaging member" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the direction" in line 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the distal body" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the distal direction" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the energy source" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "an elongated plunger rod" in line 2. Claim 13 is dependent upon claim 1 and claim 1 already recites “a plunger rod” in line 10-11. Thus it is unclear if the elongated plunger rod (1) refers to the claim 1 plunger rod or (2) is a second plunger rod. The claim is interpreted regarding scenario (1). If this interpretation is correct then the elements related to plunger rod should be recited consistently (the claims should recite an “elongated plunger rod” or a “plunger rod”).
Claim 13 recites the limitation "the distal end" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the medicant" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the medicant" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims dependent thereon are rejected for the same reasons.
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) 1-3, 9 and 10 is/are rejected under 35 U.S.C. 102(A) as being anticipated by Pub. No.: US 2007/0043321 A1 (Tai).
Regarding claim 1, Tai discloses (see fig. 5) a cassette housing for a medicament delivery device cassette unit, the cassette housing comprising: a main body 52 extending along a first longitudinal axis (see annotated figure below) between a proximal end (at 522) and a distal end (at 528); wherein the main body 52 defines an interior chamber 526 for receiving (chamber 526 is capable of receiving such a container) a medicament container; a distal cover 528 attached to the distal end (at 528) of the main body 52; wherein the distal cover 528 comprises a covering wall (see annotated figure below) extending across (see annotated figure below) the distal end of the interior chamber of the main body 52 in a direction transverse (see annotated figure below) to the first longitudinal axis; and wherein the covering wall comprises a key slot (see cruciform shaped key slot in annotated figure below) configured to receive a key (cruciform shape in shading in annotated figure below) of a plunger 542 rod 548 of the medicament delivery device, such that when the key and the key slot are matched (see “match” at par. 42, middle), the key of the plunger rod 548 followed by a plunger rod body (see annotated figure below) of the plunger rod can enter into the cassette housing 52 through the key slot.
PNG
media_image1.png
614
520
media_image1.png
Greyscale
[AltContent: textbox (covering wall)][AltContent: arrow][AltContent: arrow][AltContent: textbox (longitudinal axis L1)][AltContent: arrow][AltContent: textbox (plunger rod body)][AltContent: arrow][AltContent: oval][AltContent: textbox (longitudinal axis L2)][AltContent: arrow][AltContent: textbox (proximal end)][AltContent: arrow]
Regarding claim 2, Tai discloses (see fig. 4) a plunger 542 rod 548 for a medicament delivery device (see title), the plunger rod comprising: a plunger rod body (21) (see annotated figure above) extending along a second longitudinal axis (see annotated figure above) between a proximal end (opposite end of 546) and a distal end (at 546); a key (cruciform shape in shading in annotated figure above) attached to the proximal end of the plunger rod body; wherein the key is configured to fit into a key slot (see cruciform shaped key slot in annotated figure above) on a cassette housing 52, such that when the key and the key slot are matched (see “match” at par. 42, middle), the key followed by the plunger rod body can enter into (see annotated figure above) the cassette housing through the key slot (13a).
Regarding claim 3, Tai discloses (see fig. 5) a sub-assembly for a medicament delivery device (see title and par. 42, bottom), the sub-assembly comprising: a cassette housing 52 comprising; a main body 52 extending along a first longitudinal axis (see annotated figure above) between a proximal end (at 522) and a distal end (at 528); wherein the main body defines an interior chamber 526 for receiving a medicament container (the interior chamber is capable of receiving a medicant container); a plunger rod body (see annotated figure above) extending along a second longitudinal axis (see annotated figure above) between a proximal end (opposite end of 546) and a distal end (at 546); a key (cruciform shape in shading in annotated figure above) attached to the proximal end of the plunger rod body; a distal cover 528 attached to the distal end of the main body; wherein the distal cover 528 comprises a covering wall (see annotated figure above) extending across the distal end of the interior chamber of the main body in a direction transverse to the first longitudinal axis; and wherein the covering wall comprises a key slot (see cruciform shaped key slot in annotated figure below) configured to receive the key of the plunger rod, such that when the key and the key slot are matched (see “match” at par. 42, middle), the key of the plunger rod followed by plunger rod body of the plunger rod can enter (see annotated figure above) into the cassette housing through the key slot.
Regarding claim 9, Tai discloses (see fig. 5) the key (cruciform shape in shading in annotated figure above) of the plunger rod 548 is rotationally fixed (see annotated figure above) to the plunger rod body (see annotated figure above); and wherein the plunger rod body (see annotated figure above) is rotatable around the second longitudinal axis (see annotated figure above) from a first position to a second position. The user can rotate the instant body about the instant axis (see fig. 5, bottom).
Regarding claim 10, Tai discloses (see fig. 5) wherein the key of the plunger rod 548 is misaligned with the key slot (see cruciform shaped key slot in annotated figure above) of the distal cover 528 of the cassette housing 52 in a circumferential direction relative to the first longitudinal axis when the plunger rod 548 is in the first position and at least a portion of a proximal engaging member 544 is aligned with a distal engaging member 546 in the direction of the first longitudinal axis (see annotated figure above). The claim is interpreted such that that there are two “wherein” conditions: (1) “the key of the plunger rod is misaligned …” and (2) “at least a portion of the proximal engaging member …” such that the two conditions do not have to happen at the same time (for example the claim does not recite “and when at least a portion …”). Thus the proximal engaging member 544 can be engaged with distal engaging member 546 when the plunger rod is within cassette housing 52 and the claimed misalignment occurs when the plunger rod 548 is outside of the cassette housing 52 when the user can rotate the plunger rod 548 to affect the misalignment. Alternatively 484 may be the proximal engaging member and 522 may be the distal engaging member 522 (wherein the two instant conditions can happen at the same time; in this alternative scenario the cassette housing and main body are the structure 52, as discussed in the claim 3 analysis above, except for member 522).
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.
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.
Claim(s) 4-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of Pub. No.: US 2014/0290792 A1 (Avery).
Regarding claim 4, Tai discloses the current invention as claimed and discussed above. Tai does not disclose a distal body extending along a third longitudinal axis between a proximal end and a distal end; wherein the distal body is configured be attached to the cassette housing; wherein the plunger rod is arranged in the distal body and is telescopic relative to the proximal end of the distal body (3).
Avery teaches (see figs. 1- 6) a medicant delivery device 10 and further teaches a distal body 12 extending along a third longitudinal axis (long. axis of body 12) between a proximal end (at 17 in fig. 1) and a distal end 13; wherein the distal body 12 is configured be attached to a cassette housing (14 or 100); wherein a plunger rod (2) 9 is arranged in the distal body 12 and is telescopic (see axial forces provided by piston rod 9 discussed at par. 165, bottom) relative to the proximal end (at 17 in fig. 1) of the distal body 12. It is noted that “distal end” and “proximal end” are interpreted consistent with applicant p. 2, ll. 4-15.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Tai with a distal body extending along a third longitudinal axis between a proximal end and a distal end; wherein the distal body is configured be attached to the cassette housing; wherein the plunger rod (2) is arranged in the distal body and is telescopic relative to the proximal end of the distal body as taught by Avery in order to facilitate permitting use of a multi-use medicant cartridge 20 with convenient dose setting feature for user (see Avery pars. 167-168). This results in for example substituting the cassette housing 14 of Avery for cassette housing 52 of Tai such to accommodate the distal body 12 of Avery (see Avery fig. 1). It is noted that in the scenario of cassette housing 100 this modification includes modifying distal body 12 to connect with cartridge housing 100 via the bayonet coupling shown in fig. 5 (see annotation at “proximal engaging member” in annotated fig. 5 below).
Regarding claim 5, Tai in view of Avery teach the current invention as claimed and discussed above. The teachings of Avery applied to Tai in the claim 4 analysis above include (see fig. 5) wherein the cassette housing 100 comprises a proximal engaging member (see annotated figure below; i.e. slot/track portion of bayonet coupling discussed in par. 180) attached at the distal end 106 of a main body 102 of the cassette housing 100; wherein the distal body 12 comprises a distal engaging member (see par. 180: “where the cartridge holder 100 is used for a reusable drug delivery device, this proximal end 106 may comprise a releasable coupling ( e.g., a thread, a snap lock that is released through a thread, a bayonet connection or other similar form fit or snap fit connection). In this manner, the holder 100 may be releasably connected to the dose setting mechanism [12] of a drug delivery device [10]”) attached to a proximal end of the distal body 12; and wherein the cassette housing is attached to (see par. 180 information above) the distal body when the proximal engaging member is fastened to the distal engaging member.
PNG
media_image3.png
377
518
media_image3.png
Greyscale
[AltContent: textbox (proximal engaging member)][AltContent: arrow][AltContent: textbox (track or slot of bayonet connection)][AltContent: arrow]
Regarding claim 6, Tai in view of Avery teach the current invention as claimed and discussed above. The teachings of Avery applied to Tai in the claim 4 analysis above include wherein the proximal engaging member is configured to be fastened to the distal engaging member in the direction of the third longitudinal axis through a bayonet connection (see par. 180). See bayonet coupling in annotated figure above. One of ordinary skill understands that a bayonet connection includes a complementary structure including a protrusion that coincides with the track/slot.
Regarding claim 8, The combination of Tai in view of Avery teach the current invention as claimed and discussed above. The combination teaches wherein the proximal engaging member (see annotated figure above; i.e. slot/track portion of bayonet coupling discussed in par. 180 extends towards the proximal end 104) is positioned closer (see Avery fig. 5) to the proximal end 104 of the cassette housing 100 (see fig. 5) than a distal end of the distal cover (the distal cover 528 in Tai fig. 5 is at the distal end of the cassette housing and does not extend towards the proximal end of the cassette housing); and wherein the key (see shading in annotated figure above) of the plunger rod protrudes beyond at least a portion of the distal engaging member in the proximal direction (towards the injection site) of the distal body (the plunger rod 9 in Avery fig. 1 protrudes in the proximal direction passed the distal body 12 and thus would protrude beyond the distal engaging member associated with the distal body 12, the distal engaging member being the bayonet protrusions that couple to the bayonet slots of the proximal engaging member in Avery fig. 5.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of Avery, as evidenced by US 2023/0226277 A1 (Plumptre).
Regarding claim 7, Tai in view of Avery teach the current invention as claimed and discussed above. Tai does not disclose wherein the proximal engaging member is a bayonet protrusion; and wherein the distal engaging member is a bayonet slot (Tai discloses that proximal engaging member is a slot (see annotated figure above) and the distal engaging member is a bayonet protrusion (see par. 180 discussing bayonet connection wherein be definition a protrusion fits into the slot of annotated figure above). It is further noted that it has been held that a reversal of parts is considered to be an obvious modification (In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955); MPEP 2144.04.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to reverse Tai in view of Avery’s the proximal engaging member is a bayonet slot and wherein the distal engaging member is a bayonet protrusion to arrive at the claimed the proximal engaging member is a bayonet protrusion; and wherein the distal engaging member is a bayonet slot because a modification regarding a reversal of parts is considered an obvious modification. It is within the working scope of one of ordinary skill in the art to make such a reversal as evidenced by Plumptre (see in figs. 1-3 proximal engaging member 4 being a bayonet protrusion 4 of a cassette housing (2a for example) and distal engaging member 3 being a bayonet slot 3 of a distal body 1).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of Pub. No.: US 2013/0041346 A1 (Alon) as evidenced by Plumptre and Avery.
Regarding claim 11, Tai discloses the current invention as claimed and discussed above. Tai discloses (see fig. 5) an energy source is configured to connect to the plunger rod 548 for driving the plunger rod. The user pushes the plunger rod. Tai does not disclose wherein a distal body is configured to receive an energy source of the medicament delivery device; the energy source is configured to connect to the plunger rod for driving the plunger rod relative to the distal body.
Alon teaches (see figs. 1-2) a medicant delivery device 20 and further teaches a distal body (at 24a,24b) is configured to receive an energy source (e.g. a motor 60) of the medicament delivery device, the energy source 60 is configured to connect to a plunger rod 54 for driving a plunger rod relative to the distal body. Plumptre is evidence that such motors can be used for power assist (see par. 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Tai with a distal body is configured to receive an energy source of the medicament delivery device, the energy source is configured to connect to the plunger rod for driving the plunger rod relative to the distal body as taught by Tai in order to facilitate to assist the user in medicant injection (see Plumptre par. 43). A way to implement the teachings of Alon (i.e. a motor in a distal body the motor connected with a plunger rod) with Tai is to implement the distal body in a similar way of the combination of Tai in view of Avery herein and including a motor to assist the user with the pushing action discussed in par. 168 of Avery by way of a power assist motor. For example this can result in substituting a cassette housing 14 of Avery for cassette housing 52 of Tai such to accommodate a distal body such as that 12 of Avery (see Avery fig. 1) wherein Alon teaches the general concept of a distal body and a motor therein.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of Alon as evidenced by Plumptre, Avery and US 5928201 (Poulsen).
Regarding claim 12, The combination of Tai in view of Alon as evidenced by Plumptre and Avery teach the current invention as claimed and discussed above. The teachings of Alon applied above include wherein the plunger rod 54 is configured to move along the third longitudinal axis (an axis coinciding with the second longitudinal axis; the claim places no requirements on the third long. axis) in the distal direction (away from the medicant injection site) relative to the distal body from a first position to a second position (Avery is evidence that when a cartridge is spent then the cartridge is replaced, see par. 3; Poulsen is evidence that when a cartridge is replaced then the piston is retracted and thus the plunger rod of the combination would be moved in the distal direction, see Poulsen abstract). The instant movement in the distal direction can take place “when” the energy source of the medicament delivery device received in the distal body has sufficient power to carry out a medicament delivery operation. For example, the motor moves the plunger rod as evidenced by Poulsen abstract.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of WO 2021/038197 (Spofforth).
Regarding claim 13, Tai discloses (see fig. 5) a method of assembling a medicament delivery device comprising: the cassette housing 52 according to claim 1, and an elongated plunger rod 548 extending along the second longitudinal axis (see annotated figure above) between a proximal end (see annotated figure above) and a distal end (at 546), the method comprising the steps of: covering the interior chamber 526 from the distal end (at 528) of the cassette housing 52 with the distal cover 528, wherein the distal cover comprises the key slot (see cruciform shape in cover 528 in fig. 5) perpendicular (see annotated figure above) to the first longitudinal axis (see annotated figure above); attaching the key (see cruciform shape in shading at 546 in annotated figure above) that is matched (see pars. 12 and 42) with the key slot to a proximal end of the plunger rod (see key in shading at proximal end of plunger rod in annotated figure above wherein the key is attached in an integral manner by way of the forming of the plunger rod. Tai does not disclose inserting the medicament container into the interior chamber of the cassette housing.
Spofforth teaches a medicant delivery device (see claim 1) and further teaches inserting a medicament container (see slot 224 for example in fig. 10 is the location of cartridge discussed at page 15, l.20 to page 16, l. 5) into an interior chamber 224 of a cassette housing (see 50 in fig. 5 or wall at 212 in fig. 10; the latter embodiment provides for various size medicant containers, see page 16, l. 15). Spofforth’s medicant container is compatible with a cruciform key (see page 15, ll. 20-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Tai with inserting the medicament container into the interior chamber of the cassette housing as taught by Spofforth in order to facilitate permitting reuse of the medicant delivery device thus reducing cost and conserving materials.
Regarding claim 14, Tai in view of Spofforth teach the current invention as claimed and discussed above. Tai discloses (see fig. 5) the method further comprising the steps of: selecting the distal cover 528 with the key slot (see fig. 5) in a certain geometry (cruciform) according to the medicament (see pars. 12 and 42) contained within the inserted medicament container (as modified with Alon) before covering the interior chamber 526 from the distal end of the cassette housing 52 with the distal cover 528.
Regarding claim 15, Tai in view of Spofforth teach the current invention as claimed and discussed above. Tai discloses (see fig. 5) the method further comprising the steps of: selecting the key (see shaded in key in annotated figure above) with a certain geometry (cruciform) according to the medicament (see pars. 12 and 42) contained within the inserted medicament container (as modified by Alon) before attaching the key to the proximal end of the plunger rod. The key cruciform cross section is selected before the plunger rod 548 is formed and this key is according to a corresponding medicant as pointed out in pars. 12 and 42. The combination includes using a medicant container corresponding with the cruciform shape key (see Spofforth page 15, ll. 20-24 and fig. 9).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Keyed medical delivery devices or pumps: US 20070043321 20140290792 20230226277 20130041346 5928201; JPS48-6460
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC J AMAR whose telephone number is (571)272-9948. The examiner can normally be reached M-F 9:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARC AMAR/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
Prosecution Insights