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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 21 objected to because of the following informalities:
Line 4 recites “an injection of a dose of medicament”. Line 3 of claim 21 already provides antecedent basis for an injection of a dose of a medicament. Examiner suggests replacing “an injection of a dose of medicament” in line 4 of claim 21 with “the injection of the dose of medicament” to put the claim in clearer form.
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 20-24 and 27 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.
In regard to claim 20,
Line 1-2 recites “the engagement of the plunger rod with the feedback portion”. Claim 20 depends on claim 18 and claim 15. Claim 15 recites “wherein the feedback portion is configured to engage with the engagement structure”. It is unclear if “the engagement of the plunger rod with the feedback portion” in claim 20 refers to “the engagement of the plunger rod with the engagement structure” or refers to an engagement of the plunger rod with the feedback portion. For examination purposes Examiner construes “the engagement of the plunger rod with the feedback portion” to be “the engagement of the plunger rod with the engagement structure”. Examiner suggests replacing “the engagement of the plunger rod with the feedback portion” in line 1-2 of claim 20 with “the engagement of the plunger rod with the engagement structure”.
Line 3 recites “the proximal direction”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “the proximal direction” to be “a proximal direction”. Examiner suggests replacing “the proximal direction” in line 3 of claim 20 with “a proximal direction”.
Line 2-3 recites “a displacement of the plunger rod in the proximal direction causes a breakage of the one or more attachment parts”. It is unclear if a method step is being claimed due to the term “causes”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “a displacement of the plunger rod in the proximal direction causes a breakage of the one or more attachment parts” to be “a displacement of the plunger rod in a proximal direction is configured to cause a breakage of the one or more attachment parts”. Examiner suggests replacing “a displacement of the plunger rod in the proximal direction causes a breakage of the one or more attachment parts” in line 2-3 of claim 20 with “a displacement of the plunger rod in a proximal direction is configured to cause a breakage of the one or more attachment parts”.
Examiner notes claim 21 is similarly rejected by virtue of its dependency on claim 20.
In regard to claim 21,
Line 1-4 recites “wherein when the engagement structure is attached at the distal end of the plunger rod to indicate an end of an injection of a dose of a medicament; or is attached at the proximal end of the plunger rod to indicate a beginning of an injection of a dose of medicament”. It is unclear what the engagement structure is required to do “when the engagement structure is attached at the distal end of the plunger rod to indicate an end of an injection of a dose of a medicament”. For examination purposes Examiner construes “wherein when the engagement structure is attached at the distal end of the plunger rod to indicate an end of an injection of a dose of a medicament” to be “wherein the engagement structure is attached at the distal end of the plunger rod to indicate an end of an injection of a dose of a medicament”. Examiner suggests removing the term “when” in line 2 of claim 21.
Line 3 recites “the proximal end of the plunger rod”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “the proximal end of the plunger rod” to be “a proximal end of the plunger rod”. Examiner suggests replacing “the proximal end of the plunger rod” in line 3 of claim 21 with “a proximal end of the plunger rod”.
In regard to claim 22,
Line 2 recites “the rear subassembly”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “the rear subassembly” to be “a rear subassembly”. Additionally, it is noted that claim 22 is drawn to a feedback mechanism, not a medicament delivery device. It is unclear if the rear cap of the rear subassembly is a part of the medicament delivery device or the feedback mechanism. If intended to be part of the medicament delivery device, claim 22 would need to state “are configured to be moulded” as the rear cap of the rear subassembly would not be positively required by the claim since the medicament delivery device is not positively required by the claim. Examiner suggests replacing “the rear subassembly” in line 2 of claim 22 with “a rear subassembly”.
In regard to claim 23,
Line 3 recites “the rear subassembly”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “the rear subassembly” to be “a rear subassembly”. Examiner suggests replacing “the rear subassembly” in line 3 of claim 23 with “a rear subassembly”. Additionally, it is noted that claim 23 is drawn to a feedback mechanism, not a medicament delivery device. It is unclear if the rear subassembly is a part of the medicament delivery device or the feedback mechanism. If intended to be part of the medicament delivery device, claim 23 would need to state “are configured to be welded or glued” as the rear subassembly would not be positively required by the claim since the medicament delivery device is not positively required by the claim.
Line 3 recites “the housing”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “the housing” to be “a housing”. Examiner suggests replacing “the housing” in line 3 of claim 23 with “a housing”. Additionally, it is noted that claim 23 is drawn to a feedback mechanism, not a medicament delivery device. It is unclear if the housing is a part of the medicament delivery device or the feedback mechanism. If intended to be part of the medicament delivery device, claim 23 would need to state “are configured to be welded or glued” as the housing would not be positively required by the claim since the medicament delivery device is not positively required by the claim.
In regard to claim 24,
Line 2 recites “the force of a spring”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “the force of a spring” to be “a force of a spring”. Examiner suggests replacing “the force of a spring” in line 2 of claim 24 with “a force of a spring”.
Line 4 recites “the rear subassembly”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “the rear subassembly” to be “a rear subassembly”. Examiner suggests replacing “the rear subassembly” in line 4 of claim 24 with “a rear subassembly”.
Line 4 recites “the housing”. There is insufficient antecedent basis for the limitation in this claim. For examination purposes Examiner construes “the housing” to be “a housing”. Examiner suggests replacing “the housing” in line 4 of claim 24 with “a housing”.
In regard to claim 27,
Line 7 recites “a medicament”. Line 6 of claim 27 also recites “a medicament”. It is unclear if the medicament of line 7 is a second medicament or if the medicament of line 7 is the same as the medicament of line 6. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a medicament” in line 7 of claim 27 with “the medicament”.
Claim Rejections - 35 USC § 102
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 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.
Claims 15-24 and 26-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a first interpretation of Baumeyer (U.S. PG publication 20190269856).
In regard to claim 15,
Baumeyer discloses a feedback mechanism (see all of figure 5A-5B not including item 22 or item 23) for a medicament delivery device (paragraph [0094]; see figure 1A and 1B, item 10; Examiner notes “for a medicament delivery device” is a functional limitation and the medicament delivery device is not positively required by the claim. The feedback mechanism is fully capable of being for a medicament delivery device as supported by paragraph [0094]), the feedback mechanism comprising a feedback portion (figure 5A item 39, 44, and 45; paragraph [0099]) and a plunger rod (figure 5A, item 21);
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wherein the plunger rod comprises an engagement structure (see figure 5A above; wherein the outer surface of the side of the plunger forms an engagement structure which engages with item 39; paragraph [0095]);
wherein the feedback portion comprises one or more attachment parts (figure 5A, item 46);
wherein the one or more attachment parts are configured to connect the feedback portion to another part of the medicament delivery device (see figure 5A wherein the one or more attachment parts are configured to connect the feedback portion to item 23); and
wherein the feedback portion is configured to engage with the engagement structure during use of the medicament delivery device so that the one or more attachment parts detach or break during movement of the plunger rod relative to the feedback portion (paragraph [0095]-[0103]).
In regard to claim 16,
Baumeyer discloses the feedback mechanism of claim 15, wherein the one or more attachment parts are configured to connect the feedback portion to a rear subassembly or to a housing of the medicament delivery device (see figure 5A wherein item 46 is connected to item 23).
In regard to claim 17,
Baumeyer discloses the feedback mechanism of claim 15, wherein the feedback portion comprises a central opening (see opening between each item 39) through which the plunger rod can move towards a proximal end of the medicament delivery device (see figure 5B compared to figure 5A; paragraph [0094]).
In regard to claim 18,
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Baumeyer discloses the feedback mechanism of claim 15, wherein the engagement structure is attached to the plunger rod at a distal end of the plunger rod (see figure 5A above).
In regard to claim 19,
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Baumeyer discloses the feedback mechanism of claim 15, wherein the engagement structure is attached to the plunger rod at a proximal end of the plunger rod (see figure 5A above).
In regard to claim 20,
Baumeyer discloses the feedback mechanism of claim 18, wherein after the engagement of the plunger rod with the feedback portion, a displacement of the plunger rod in the proximal direction causes a breakage of the one or more attachment parts (paragraph [0097]-[0099]).
In regard to claim 21,
Baumeyer discloses the feedback mechanism of claim 20, wherein when the engagement structure is attached at the distal end of the plunger rod to indicate an end of an injection of a dose of a medicament (paragraph [0097]-[0099]); or is attached at the proximal end of the plunger rod to indicate a beginning of an injection of a dose of medicament.
In regard to claim 22,
Baumeyer discloses the feedback mechanism of claim 15, wherein the feedback portion, the one or more attachment parts and a rear cap of the rear subassembly are moulded as one piece (Examiner notes the claimed phrase “the one or more attachment parts and a rear cap of the rear subassembly are moulded as one piece” is being treated as a product-by-process limitation. It is well settled that “product by process” limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. Additionally, Applicant has the burden of showing that the method language necessarily produces a structural difference. As such, the language “the one or more attachment parts and a rear cap of the rear subassembly are moulded as one piece” only requires the feedback portion, the one or more attachment parts, and a rear cap of the rear subassembly, to be one piece, which does not distinguish the invention from Baumeyer, who teaches the structure as claimed as shown in figure 5A in which item 44 is attached to item 46 and item 23. See MPEP 2113).
In regard to claim 23,
Baumeyer discloses the feedback mechanism of claim 15, wherein the feedback portion is welded or glued to the one or more attachment parts (Examiner notes the claimed phrase “the feedback portion is welded or glued to the one or more attachment parts” is being treated as a product-by-process limitation. It is well settled that “product by process” limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. Additionally, Applicant has the burden of showing that the method language necessarily produces a structural difference. As such, the language “the feedback portion is welded or glued to the one or more attachment parts” only requires the feedback portion to be attached to the one or more attachment parts, which does not distinguish the invention from Baumeyer, who teaches the structure as claimed as shown in figure 5A in which item 44 is attached to item 46), and/or the one or more attachment parts are welded or glued to the rear subassembly or to the housing (Examiner notes the claimed phrase “the one or more attachment parts are welded or glued to the rear subassembly or to the housing” is being treated as a product-by-process limitation. It is well settled that “product by process” limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. Additionally, Applicant has the burden of showing that the method language necessarily produces a structural difference. As such, the language “the one or more attachment parts are welded or glued to the rear subassembly or to the housing” only requires the one or more attachment parts to be attached to the rear subassembly or to the housing, which does not distinguish the invention from Baumeyer, who teaches the structure as claimed as shown in figure 5A in which item 46 is attached to item 23. See MPEP 2113).
In regard to claim 24,
Baumeyer discloses the feedback mechanism of claim 15, wherein the one or more attachment parts are configured to comprise a breaking point (figure 5A, item 48) such that the force of a spring that displaces the plunger rod is sufficient for breaking off all of the one or more attachment parts (figure 5A, item 46) from a rear cap of the rear subassembly or from the housing (see figure 5B; paragraph [0102]).
In regard to claim 26,
Baumeyer discloses a medicament delivery device (see figure 1A and 1B) comprising the feedback mechanism according to claim 15 (see rejection of claim 15 above; paragraph [0069] and [0094]).
In regard to claim 27,
Baumeyer discloses the medicament delivery device of claim 26, further comprising:
a tubular housing (figure 5A, item 23);
a front subassembly (figure 1B, item 18 and 17), the front subassembly comprising a medicament container (figure 1B, item 18; paragraph [0060]) and a medicament delivery member (figure 1B, item 17); and
a rear subassembly (figure 1B, item 13 and figure 5A, item 22) comprising an activation mechanism (figure 1B, item 13; paragraph [0064]) and an actuation mechanism (figure 5A, item 22) for expelling a medicament (paragraph [0094]), wherein the actuation mechanism is arranged to cause the plunger rod to expel a medicament out of the medicament container (paragraph [0094]).
In regard to claim 28,
Baumeyer discloses the medicament delivery device of claim 26, wherein the medicament delivery device is a single-use disposable device (see analysis above wherein once item 45 has been broken, the device cannot be used again).
Claims 15-16, 18, 20-24, and 26-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a second interpretation of Baumeyer (U.S. PG publication 20190269856). Examiner notes the second interpretation differs from the first in regard to the feedback portion.
In regard to claim 15,
Baumeyer discloses a feedback mechanism (see all of figure 5A-5B not including item 22 or item 23) for a medicament delivery device (paragraph [0094]; see figure 1A and 1B, item 10; Examiner notes “for a medicament delivery device” is a functional limitation and the medicament delivery device is not positively required by the claim. The feedback mechanism is fully capable of being for a medicament delivery device as supported by paragraph [0094]), the feedback mechanism comprising a feedback portion (figure 5A item 44 and 45; paragraph [0099]) and a plunger rod (figure 5A, item 21);
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wherein the plunger rod comprises an engagement structure (see figure 5A above; wherein the outer surface of the distal end of the plunger forms an engagement structure which engages with item 44);
wherein the feedback portion comprises one or more attachment parts (figure 5A, item 46);
wherein the one or more attachment parts are configured to connect the feedback portion to another part of the medicament delivery device (see figure 5A wherein the one or more attachment parts are configured to connect the feedback portion to item 23); and
wherein the feedback portion is configured to engage with the engagement structure during use of the medicament delivery device so that the one or more attachment parts detach or break during movement of the plunger rod relative to the feedback portion (paragraph [0095]-[0103]).
In regard to claim 16,
Baumeyer discloses the feedback mechanism of claim 15, wherein the one or more attachment parts are configured to connect the feedback portion to a rear subassembly or to a housing of the medicament delivery device (see figure 5A wherein item 46 is connected to item 23).
In regard to claim 18,
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Baumeyer discloses the feedback mechanism of claim 15, wherein the engagement structure is attached to the plunger rod at a distal end of the plunger rod (see figure 5A above).
In regard to claim 20,
Baumeyer discloses the feedback mechanism of claim 18, wherein after the engagement of the plunger rod with the feedback portion, a displacement of the plunger rod in the proximal direction causes a breakage of the one or more attachment parts (paragraph [0097]-[0099]).
In regard to claim 21,
Baumeyer discloses the feedback mechanism of claim 20, wherein when the engagement structure is attached at the distal end of the plunger rod to indicate an end of an injection of a dose of a medicament (paragraph [0097]-[0099]); or is attached at the proximal end of the plunger rod to indicate a beginning of an injection of a dose of medicament.
In regard to claim 22,
Baumeyer discloses the feedback mechanism of claim 15, wherein the feedback portion, the one or more attachment parts and a rear cap of the rear subassembly are moulded as one piece (Examiner notes the claimed phrase “the feedback portion, the one or more attachment parts and a rear cap of the rear subassembly are moulded as one piece” is being treated as a product-by-process limitation. It is well settled that “product by process” limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. Additionally, Applicant has the burden of showing that the method language necessarily produces a structural difference. As such, the language “the feedback portion, the one or more attachment parts and a rear cap of the rear subassembly are moulded as one piece” only requires the feedback portion, the one or more attachment parts, and a rear cap of the rear subassembly, to be one piece, which does not distinguish the invention from Baumeyer, who teaches the structure as claimed as shown in figure 5A in which item 44 is attached to item 46 and item 23. See MPEP 2113).
In regard to claim 23,
Baumeyer discloses the feedback mechanism of claim 15, wherein the feedback portion is welded or glued to the one or more attachment parts (Examiner notes the claimed phrase “the feedback portion is welded or glued to the one or more attachment parts” is being treated as a product-by-process limitation. It is well settled that “product by process” limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. Additionally, Applicant has the burden of showing that the method language necessarily produces a structural difference. As such, the language “the feedback portion is welded or glued to the one or more attachment parts” only requires the feedback portion to be attached to the one or more attachment parts, which does not distinguish the invention from Baumeyer, who teaches the structure as claimed as shown in figure 5A in which item 44 is attached to item 46), and/or the one or more attachment parts are welded or glued to the rear subassembly or to the housing (Examiner notes the claimed phrase “the one or more attachment parts are welded or glued to the rear subassembly or to the housing” is being treated as a product-by-process limitation. It is well settled that “product by process” limitations in claims drawn to structure are directed to the product, per se, no matter how actually made. Additionally, Applicant has the burden of showing that the method language necessarily produces a structural difference. As such, the language “the one or more attachment parts are welded or glued to the rear subassembly or to the housing” only requires the one or more attachment parts to be attached to the rear subassembly or to the housing, which does not distinguish the invention from Baumeyer, who teaches the structure as claimed as shown in figure 5A in which item 46 is attached to item 23. See MPEP 2113).
In regard to claim 24,
Baumeyer discloses the feedback mechanism of claim 15, wherein the one or more attachment parts are configured to comprise a breaking point (figure 5A, item 48) such that the force of a spring that displaces the plunger rod is sufficient for breaking off all of the one or more attachment parts from a rear cap of the rear subassembly or from the housing (see figure 5B; paragraph [0102]).
In regard to claim 26,
Baumeyer discloses a medicament delivery device (see figure 1A and 1B) comprising the feedback mechanism according to claim 15 (see rejection of claim 15 above; paragraph [0069] and [0094]).
In regard to claim 27,
Baumeyer discloses the medicament delivery device of claim 26, further comprising:
a tubular housing (figure 5A, item 23);
a front subassembly (figure 1B, item 18 and 17), the front subassembly comprising a medicament container (figure 1B, item 18; paragraph [0060]) and a medicament delivery member (figure 1B, item 17); and
a rear subassembly (figure 1B, item 13 and figure 5A, item 22) comprising an activation mechanism (figure 1B, item 13; paragraph [0064]) and an actuation mechanism (figure 5A, item 22) for expelling a medicament (paragraph [0094]), wherein the actuation mechanism is arranged to cause the plunger rod to expel a medicament out of the medicament container (paragraph [0094]).
In regard to claim 28,
Baumeyer discloses the medicament delivery device of claim 26, wherein the medicament delivery device is a single-use disposable device (see analysis above wherein once item 45 has been broken, the device cannot be used again).
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 25 is rejected under 35 U.S.C. 103 as being unpatentable over the second interpretation of Baumeyer (U.S. PG publication 20190269856).
In regard to claim 25,
Baumeyer discloses the feedback mechanism of claim 15, wherein the feedback portion is a plate (see figure 5A, item 44).
Baumeyer is silent as to wherein the feedback portion is a circular disc.
It would have been an obvious matter of design choice to modify the shape of the plate of Baumeyer to be a circular disc since applicant has not disclosed that having wherein the feedback portion is a circular disc 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 feedback portion is a circular disc, 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 shape of the plate of Baumeyer to be a circular disc since a change in the shape of a prior art device is a design consideration within the skill of the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Paragraph [0040] of the instant disclosure further supports that the feedback portion can be other shapes besides circular.
Conclusion
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
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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