DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/05/2026 is acknowledged.
Claims 28-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/05/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a) and/or PCT Article 7, Paragraph (1). The drawings must show every feature of the invention specified in the claims, when they are necessary for the understanding of the invention. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
the medicament delivery member
the distal opening has a smaller diameter than the proximal opening
the inner rim –shoulder-- of the distal opening of the tubular body
the medicament delivery device abutting against the inner rim or shoulder
the longitudinal seal
a rolled-up structure
an interlocked nested structure
No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 23-25 are objected to because of the following informalities.
Claim 23 should read --The cap assembly in which the arm is attached to the first ring and the arm extends from the first ring to the second ring when the cap assembly is in the first configuration.—
Claim 24 should read --The cap assembly of claim 23, wherein the protrusion extends beyond the slit in a distal direction when the cap assembly is in the first configuration, the protrusion also extends circumferentially beyond a circumferential width of the arm, whereby the protrusion defines a circumferentially extending part, wherein the circumferentially extending part of the protrusion is configured to move beyond an opening of the slit when the first ring is moved in a first direction, so that the circumferentially extending part of the protrusion inhibits a movement in a proximal direction of the tubular body when the tubular body is locked in a contracted state when in the first configuration.—
Claim 25 should read --The cap assembly of claim 24, wherein when the first ring is moved in a second directionextending part passes through the slit, such that the protrusion can move in the proximal direction, thereby allowing the tubular body to move in the proximal direction.--
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are as follows.
“medicament delivery device” in Claim 16, where the generic placeholder is “device”, the functional language is “medicament delivery”, and sufficient modifying structure has not been provided; Instant application Paragraph 0003 describes medicament delivery device examples, each of which include a needle, providing sufficient modifying structure
“medicament delivery member” in Claim 16, where the generic placeholder is “member”, the functional language is “medicament delivery”, and sufficient modifying structure has not been provided; Instant application Paragraph 0025 describes members as being members, but does not provide any structure for the member, as such sufficient modifying structure is not provided
“locking mechanism” in Claim 20, where the generic placeholder is “mechanism”, the functional language is “locking” or “configured to lock the tubular body in a retracted state when in the first configuration”, and sufficient modifying structure has not been provided; Instant application Paragraph 0014 describes the locking mechanism as comprising a seal, and instant application Paragraph 0015 describes the locking mechanism as comprising a slit, providing sufficient modifying structure
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to Claim 16, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a medicament delivery member of the medicament delivery. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain what the structure of the claimed medicament delivery member.
Instant application Paragraph 0025 only states a member is a member, which does not provide any structure for the member. The member does not appear to be shown in the drawings, and one of ordinary skill in the art would not be able to reasonably conclude the structure of the claimed member based on the original disclosure. As such, the original disclosure fails to provide sufficient written description for the claimed medicament delivery member of the medicament delivery.
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 16-27 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.
As to Claim 16, the limitation “the tubular body comprises a proximal opening for receiving a proximal part of a medicament delivery device”, in Lines 6-7, is indefinite in light of the specification. When referencing instant application Figures 1-4, one of ordinary skill in the art would conclude the top end of medicament delivery device 6 is the distal end, since the distal opening 8 is at the top of the tubular body 4. As such, it appears the limitation should read the tubular body comprises a proximal opening for receiving a distal part of a medicament delivery device, which is how the limitation will be interpreted.
term “a medicament delivery device”, in Lines 6-7, is indefinite. It is not clear if the medicament delivery device in Lines 6-7 is the same medicament delivery device defined in the preamble, or if a second medicament delivery device is being defined. For the purpose of examination, the medicament delivery device in Lines 6-7 will be interpreted as the same medicament delivery device in the preamble.
The limitation “the cap assembly is configured to change shape from a first, not expanded, configuration for protecting a medicament delivery member of the medicament delivery device prior to use to a second, expanded, configuration for storing the medicament delivery device after use”, in Lines 8-11, is indefinite. It is not clear which structure is being used with reference to the phrase “prior to use” or “after use”. For the purpose of examination, the phrases will be interpreted to be referencing the use of the medicament delivery device.
As to Claim 18, the limitation “at a distal end of the cap assembly a first ring configured to fasten the second lid, and wherein the tubular body further comprises at a proximal end a second ring”, is indefinite. The limitation is grammatically confusing, since the limitation appears to missing transitive verbs or transitional phrases, and the limitation is organized in a confusing manner. For the purpose of examination, the limitation will be interpreted as a first ring, at a distal end of the cap assembly, is configured to fasten the second lid, and wherein a proximal end of the tubular body further comprises a second ring.
As to Claim 19, the limitation “the tubular body is a cap for the medicament delivery device, wherein the tubular body forms a sleeve around a proximal end of the medicament delivery device, wherein the distal opening has a smaller diameter than the proximal opening, and wherein the distal opening further comprises an inner rim providing an abutting shoulder for the distal end of the medicament delivery device” is indefinite in light of the preamble. The preamble states only a cap assembly is being claimed. However, Claim 19 positively claims the medicament delivery device, which is not part of the claimed cap assembly. As such, the scope of the claim is not clear, since structure outside the claimed invention is positively claimed, rendering the claim indefinite. Applicant may overcome this rejection by stating the cap assembly is configured to be used with the medicament delivery device.
The term “the distal end of the medicament delivery device” lacks antecedent basis.
Additionally, it is not clear how the medicament delivery device is able to abut against the inner rim, in light of the specification. Instant application Figure 3 and Figures 8-11 appear to show the outer diameter of the distal end –the top end-- of medicament delivery device 6 being smaller than the inner diameter of the distal opening of the tubular body, and the figures appear to show the length of the portion of the medicament delivery device being shorter in length than the length of the not expanded state of tubular body 22. As such, it is not clear how the inner rim is able to abut against the distal end of the medicament delivery device.
As to Claim 21, the limitation “the locking mechanism comprises a longitudinal seal, which seal is extending from the first ring to the second ring, wherein the seal is broken when the locking mechanism is actuated” is indefinite in light of the specification. The seal does not appear to be shown in the figures, and it is not clear how the seal works as a seal, now how the seal may be broken upon actuating the locking mechanism. Additionally, it would not be reasonably clear to one of ordinary skill in the art to determine how the claimed seal works as claimed in light of the specification.
Additionally, the phrase “which seal is extending from…” should read –in which the seal is extending.
As to Claim 27, the limitation “the tubular body has a cross sectional shape which snugly fits the shape of the medicament delivery device which is introduced into the tubular body” is indefinite in light of the preamble. The preamble states only a cap assembly is being claimed. However, Claim 27 positively claims the medicament delivery device, which is not part of the claimed cap assembly. As such, the scope of the claim is not clear, since structure outside the claimed invention is positively claimed, rendering the claim indefinite. Additionally, the phrase “the shape of the medicament delivery device” lacks antecedent basis. Applicant may overcome this rejection by stating the tubular body has a cross sectional shape which is configured to snugly fit a shape of the medicament delivery device when the medicament delivery device is introduced into the tubular body.
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.
Claims 16-22 & 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaillancourt (U.S. PGPub 2003/0114797).
As to Claim 16, Vaillancourt teaches a cap assembly (Figure 2) for a medicament delivery device (11), the cap assembly comprising:
a tubular body (22); and
a first lid (12),
wherein the tubular body (22) comprises a proximal opening (the opening of 22 connected to 25/66, as viewed in Figures 8) for receiving (as shown in Figure 13) a distal part (the right side of needle 11, as viewed in Figure 13) of a medicament delivery device (11),
wherein the tubular body (22) is expandable (as shown between Figures 1-3) in a longitudinal direction (right to left, as viewed in Figures 1-3), and
wherein the cap assembly is configured to change shape from (as shown between Figures 1-3) a first, not expanded, configuration (Figure 1) for protecting (as shown in Figure 1) a medicament delivery member (the right end of needle 11, as viewed in Figure 13) of the medicament delivery device (11) prior to use (as shown in Figure 1) to a second, expanded, configuration (Figure 3) for storing (as shown in Figure 3) the medicament delivery device (11) after use (as shown in Figure 3).
As to Claim 17, Vaillancourt teaches all the limitations of Claim 16, and continues to teach a second lid (14) which is arranged, when in the first configuration, between the tubular body and the first lid. This limitation is considered an intended use limitation. The intention to assemble the cap assembly as defined in the limitation is not a patentable limitation, since a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647; MPEP 2114(II). Applicant may make this a patentable limitation by deleting the phrase “when in the first configuration”.
When referring to Figures 11/12, one of ordinary skill in the art would conclude the first lid 12 may be removed from the second ring 24, and then arranged on housing 14, placing the second lid 14 between the tubular body 22 and the first lid 12.
As to Claim 18, Vaillancourt teaches all the limitations of Claims 16-17, and continues to teach the tubular body (22) comprises (as shown in Figures 2-3) a distal opening (the opening of 22 connected to 24/65, as viewed in Figure 8), and at a distal end (the left end, as viewed in Figure 8) of the cap assembly a first ring (24) configured to fasten (via 18/19) the second lid (13), and wherein the tubular body (22) further comprises at a proximal end (the right end of 22, as viewed in Figure 8) a second ring (13).
As to Claim 19, Vaillancourt teaches all the limitations of Claims 16-18, and continues to teach the tubular body (22) is a cap (as shown in Figures 1-3) for the medicament delivery device (11), wherein the tubular body (22) forms a sleeve (22) around (as shown in Figure 3) a proximal end (the right end of needle 11, as viewed in Figure 3) of the medicament delivery device (11), wherein the distal opening (the opening of 22 connected to 24/65, as viewed in Figure 8) has a smaller diameter than (Paragraph 0082) the proximal opening (the opening of 22 connected to 25/66, as viewed in Figures 8), and wherein the distal opening (the opening of 22 connected to 24/65, as viewed in Figure 8) further comprises an inner rim (the rim attached to 65, as viewed in Figure 12) providing an abutting shoulder (as shown in Figure 3, where needle 11 extends through 65) for the distal end (the right end of needle 11, as viewed in Figure 13) of the medicament delivery device (11).
As to Claim 20, Vaillancourt teaches all the limitations of Claims 16-18, and continues to teach the second ring (13) further comprises a locking mechanism (19) configured to lock (Paragraph 0075) the tubular body (22) in a retracted state (as shown in Figure 1) when in the first configuration (Figure 1).
As to Claim 21, Vaillancourt teaches all the limitations of Claims 16-18 & 20, and continues to teach when the locking mechanism (19) is unlocked (Paragraph 0077) the tubular body (22) is configured to expand (as shown in Figures 1-3) along an axis (the colinear axes of first and second lids 12/14, as viewed in Figures 1-3) so as to enclose (as shown in Figure 3) the medicament delivery device (11) inside (as shown in Figure 3) the tubular body (22).
As to Claim 22, Vaillancourt teaches all the limitations of Claims 16-18 & 20, and continues to teach when the locking mechanism (19) comprises a longitudinal seal (65/66, Paragraph 0096), which seal (65/66) is extending from (as shown in Figure 17) the first ring (24) to the second ring (13), wherein the seal (65/66) is broken (Paragraph 0096; as shown in Figure 8) when the locking mechanism (19) is actuated (Paragraph 0077).
As to Claim 26, Vaillancourt teaches all the limitations of Claim 16, and continues to teach the tubular body (22) comprises an expandable structure in the form of a folded accordion (as shown in Figures 1-3), or a rolled-up structure, or an interlocked nested structure.
As to Claim 27, Vaillancourt teaches all the limitations of Claim 16, and continues to teach the tubular body (22) has a cross sectional shape (the shape of tubular body 22, as shown in Figures 3) which snugly fits (as shown in Figure 3, where snugly is considered a very broad term, and needle 11 appears to be close to being in contact with tubular body 22 in Figure 3) the shape (the shape of the needle 11 in Figure 3) of the medicament delivery device (11) which is introduced into (as shown in Figure 3) the tubular body (22).
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claims 23-25 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to Claim 23, the prior art (Vaillancourt ) of record teaches all the limitations of Claims 16-18 & 20-21, as well as the locking mechanism (19) comprises a slit (19) arranged on (as shown in Figures 1-3) the second ring (13), wherein the slit (19) is configured to receive (Paragraph 0075) a protrusion (18), wherein the protrusion (18) is attached to an arm, which arm is attached to the first ring (24), but does not teach “the arm extends from the first ring to the second ring when the cap assembly is in the first configuration”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 23. The closest art of record is Vaillancourt (cited above). However, Vaillancourt describes Elements 65/66 between the respective rings in the first configuration, as shown in Figure 17. It would not be obvious to one of ordinary skill in the art to modify Vaillancourt without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 23, is neither anticipated nor made obvious by the prior art of record.
Claims 24-25 depend on Claim 23, so would also be found allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nortman (5,335,149) and Vaillancourt (4,725,267) describe similar cap assemblies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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