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 .
This is the first office action on the merits in response to the preliminary amendment filed on 08/07/2024. Claims 1-13 are pending and being examined.
Claim Objections
Claims 1 and 11-13 are objected to because of the following informalities:
Claim 1, line 13: “is removable received” is believed to be in error for --is removably received--
Claim 1, lines 5-6: “a distal longitudinally position and a proximal longitudinally position” is believed to be in error for --a distal longitudinal position and a proximal longitudinal position-- (see claim 12, lines 7-8)
Claim 1, line 11: “the distal position and the proximal position” is believed to be in error for --the distal longitudinal position and the proximal longitudinal position-- (see previous claim objection)
Claim 1, lines 16-17: “the internal injector parts includes” is believed to be in error for --the internal injector parts include--
Claim 1, line 18: “delivery of medicament” is believed to be in error for --delivery of the medicament-- (see claim 1, line 3)
Claim 11, lines 1-2 and 4: “the injector” (two instances) is believed to be in error for --the auto injector-- (see claim 1, line 1)
Claim 11, lines 4-5: “the release member” is believed to be in error for --the one or more release members-- (see claim 1, line 20)
Claim 12, lines 15 and 15-16: “the auto injector” (two instances) is believed to be in error for --the reusable auto injector-- (see claim 12, lines 1-2)
Claim 12, lines 3-4 and 15: “the cassette” (two instances) is believed to be in error for --the disposable cassette-- (see claim 12, lines 2-3)
Claim 13, lines 3-4: “the cassette” is believed to be in error for --the disposable cassette-- (see claim 13, lines 2-3)
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: "one or more release members" in claims 1-3, 5, and 7-12.
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.
Double Patenting
Claims 1-10 of this application are patentably indistinct from claims 15-17 and 20-23 of Application No. 18/575,522 (based on claim set filed on 08/07/2024). Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 and 20-23 of copending Application No. 18/575,522. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application (18/575,527) claims are broader in at least one aspect and do not recite additional features claimed in the copending application (18/575,522) claims.
This is a provisional nonstatutory double patenting rejection.
For claim 1:
Regarding the broadening aspect of the present application claims, the following comparison between the present application claims and the copending application claims highlights (see underlined features in the copending application claims) what elements have been excluded in the presentation of the present application claims.
Copending application (18/575,522) claim 15
Present application (18/575,527) claim 1
A system for administration of medicament, the system comprising a cassette and an auto injector adapted for receiving the cassette;
wherein the cassette comprises:
a syringe comprising:
a syringe medicament compartment;
an outlet at the proximal end of a syringe medicament compartment; and
a stopper positioned inside the syringe compartment, wherein the stopper is movable from a distal end of the syringe compartment towards the proximal end of the syringe compartment for emptying the medicament in the syringe compartment through the outlet;
a syringe holder for receiving the syringe;
a skin sensor longitudinally movable relative to the syringe holder between two or more longitudinal positions selected from:
a distal position;
a final locked position;
an initial locked position between the final locked position and the distal position; and
an intermediate position (see *Note1 below) between the initial locked position and the final locked position;
an index ring rotatable relative to the skin sensor between two or more rotational positions selected from:
a first rotational position;
a delivery rotational position (see*Note2 below) in which the skin sensor is moveable between the distal position and the final locked position;
a cap-release rotational position positioned between the first rotational position and the delivery rotational position;
wherein the auto injector is extending from a proximal end to a distal end along a longitudinal axis, wherein the cassette is removable received in the auto injector along the longitudinal direction;
wherein the auto injector comprises an injector housing and a multiple of internal injector parts positioned inside the injector housing, wherein the internal injector parts includes at least:
a plunger rod configured for proximal movement of the stopper inside the cassette;
a drive module adapted for moving the plunger rod proximately; and
one or more release members configured for rotating the index ring between the two or more rotational positions when the one or more release members moves proximally,
wherein the internal injector parts further includes a clutch configured for being movable between:
a first clutch position where the plunger rod and the one or more release members are longitudinally coupled for proximal movement together; and
a second clutch position where the plunger rod is decoupled from the one or more release members allowing the plunger rod to move longitudinally while the one or more release members are longitudinally stationary.
An auto injector for administering a medicament, the auto injector being adapted for receiving a cassette, the cassette comprising:
a syringe holder for receiving a syringe containing medicament;
a skin sensor longitudinally movable relative to the syringe holder between two or more longitudinal positions including at least a distal longitudinally position and a proximal longitudinally position (see *Note1 below);
an index ring rotatable relative to the skin sensor between two or more rotational positions selected including:
a first rotational position, and
a second rotational position (see *Note2 below) in which the skin sensor is moveable between the distal position and the proximal position;
wherein the auto injector is extending from a proximal end to a distal end along a longitudinal axis, wherein the cassette is removable received in the auto injector along the longitudinal direction;
wherein the auto injector comprises an injector housing and a multiple of internal injector parts positioned inside the injector housing, wherein the internal injector parts includes at least:
a plunger rod configured for proximal movement for delivery of medicament;
a drive module adapted for moving the plunger rod proximately;
one or more release members configured for rotating the index ring between the two or more rotational positions when the one or more release members moves proximally and comes into contact with the index ring, wherein the one or more release members are releasably connected to the plunger rod via a clutch; and
the clutch configured for being movable between:
a first clutch position where the plunger rod and the one or more release members are longitudinally coupled for proximal movement together; and
a second clutch position where the plunger rod is longitudinally decoupled from the one or more release members allowing the plunger rod to move longitudinally while the one or more release members are longitudinally stationary.
*Note1: the copending claim 15 limitation “an intermediate position” is equivalent to present claim 1 limitation “a proximal longitudinally position” because both involve moving the skin sensor proximally from the distal position.
*Note2: the copending claim 15 limitation “a delivery rotational position” is equivalent to present claim 1 limitation “a second rotational position” because both involve moving the skin sensor proximally from the distal position.
Thus, it is apparent, for the broadening aspect, that the copending application claim 15 includes features that are not in present application claim 1. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent of an application containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since the present application claim 1 is anticipated by the copending application claim 15, with respect to the broadening aspect, then present application claim 1 is obvious over copending application claim 15 with respect to the broadening aspect.
For dependent claim 2, the recited limitations are contained in claim 16 of Appl. No. 18/575,522.
For dependent claims 3-5, the recited limitations are contained in claim 17 of Appl. No. 18/575,522.
For dependent claim 6, the recited limitations are contained in claim 20 of Appl. No. 18/575,522.
For dependent claim 7, the recited limitations are contained in claim 21 of Appl. No. 18/575,522.
For dependent claim 8, the recited limitations are contained in claim 22 of Appl. No. 18/575,522.
For dependent claims 9-10, the recited limitations are contained in claim 23 of Appl. No. 18/575,522.
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 12-13 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.
Regarding claim 12, which depends upon claim 1, the claim recites elements that have already been recited in claim 1. These elements include “a reusable auto injector”, “a disposable cassette”, “a syringe holder”, “a skin sensor”, “an index ring”, and “one or more release members”. It is not known whether these elements refer to the same elements recited in claim 1 or are additional elements, thus rendering the claim indefinite.
Regarding claim 13, which depends upon claim 1, the claim recites elements that have already been recited in claim 1. These elements include “a reusable auto injector”, “a disposable cassette”, “a syringe holder”, and “a skin sensor”. It is not known whether these elements refer to the same elements recited in claim 1 or are additional elements, thus rendering the claim indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12, which depends upon claim 1, recites the same elements found in claim 1, which include "a reusable auto injector", "a disposable cassette", "a syringe holder', "a skin sensor", "an index ring", and "one or more release members". The claim does not include any additional limitations to further limit the claim from claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bechmann (US 9,186,459 B2: IDS reference).
Regarding claim 1, Bechmann teaches (Figs. 1 and 7) an auto injector (10 – col. 18, l. 25) for administering a medicament, the auto injector (10) being adapted for receiving a cassette (Fig. 1: comprising 100, 500, 600, and 800), the cassette comprising:
a syringe holder (800) for receiving a syringe (900) containing medicament;
a skin sensor (600) longitudinally movable relative to the syringe holder (800) between two or more longitudinal positions (col. 19, ll. 25-28) including at least a distal longitudinally position (Fig. 2C) and a proximal longitudinally position (Fig. 2B);
an index ring (500) rotatable relative to the skin sensor (600) between two or more rotational positions (col. 24, l. 67 – col. 25, l. 2) selected including:
a first rotational position (Figs. 8B and 10B), and
a second rotational position (Figs. 8C and 10C) in which the skin sensor (600) is moveable between the distal position (Fig. 2C) and the proximal position (Fig. 2B);
wherein the auto injector (10) is extending from a proximal end (Fig. 1: left end of 100) to a distal end (Fig. 1: right end of 1800) along a longitudinal axis, wherein the cassette is removable received in the auto injector (10) along the longitudinal direction (as shown by the dotted line in Fig. 1);
wherein the auto injector (10) comprises an injector housing (comprising 400 and 1400) and a multiple of internal injector parts positioned inside the injector housing (400, 1400), wherein the internal injector parts includes at least:
a plunger rod (1500) configured for proximal movement (Fig. 1: in the left direction) for delivery of medicament;
a drive module (1600) adapted for moving the plunger rod (1500) proximately;
one or more release members (1100) configured for rotating (col. 25, ll. 20-22) the index ring (500) between the two or more rotational positions (Figs. 10B-10C) when the one or more release members (1100) moves proximally (Fig. 10C: shown by left arrow) and comes into contact with the index ring (500), wherein the one or more release members (1100) are releasably connected to the plunger rod (1500) via a clutch (1108 – Fig. 7); and
the clutch (1108) configured for being movable between:
a first clutch position (locked position shown in Fig. 7C) where the plunger rod (1500) and the one or more release members (1100) are longitudinally coupled for proximal movement together; and
a second clutch position (unlocked position shown in Fig. 7E) where the plunger rod (1500) is longitudinally decoupled from the one or more release members (1100) allowing the plunger rod (1500) to move longitudinally while the one or more release members (1100) are longitudinally stationary (col. 23, ll. 23-30: “The housing or intermediate element 1400 is configured to unlock the locking member 1 108 and release the plunger rod 1500 from the plunger rod tube 1 100 when the syringe (not shown) and the plunger rod tube 1 100 is advanced to the second position, thereby activating the plunger rod driver (not shown) to advance the plunger rod 1500 in the syringe for delivering of at least one dose of medicament”).
Regarding claim 2, Bechmann teaches the invention as claimed and as discussed above for claim 1, and Bechmann further teaches (Fig. 7E) the one or more release members (1100) are coupled to the injector housing (1400) in the second clutch position (as shown in Fig. 7E).
Regarding claim 3, Bechmann teaches the invention as claimed and as discussed above for claim 1, and Bechmann further teaches (Fig. 7C, 7E, 8C, and 10C) the clutch (1108) is in the first clutch position (Fig. 7C) prior to use and wherein the clutch (1108) is configured for moving from the first clutch position (Fig. 7C) to the second clutch position (Fig. 7E) when the index ring (500) is rotated to the second rotational position (Figs. 8C and 10C) by proximal movement of the one or more release members (1100) – (as shown in Fig. 10C, when release member 1100 moves to the left, index ring 500 is rotated. Note that in Fig. 10C, needle 902 is present, thus showing that the syringe 900 has advanced due to movement of plunger rod 1500, which is only possible when clutch 1108 is in the unlocked position).
Regarding claim 4, Bechmann teaches the invention as claimed and as discussed above for claim 3, and Bechmann further teaches (Fig. 7E and 10C) the clutch (1108) is configured for remaining in the second clutch position (unlocked position shown in Fig. 7E) when the index ring (500) is in the second rotational position (Figs. 8C and 10C) and the plunger rod (1500) moves further proximally for delivery of the medicament – (as shown in Fig. 10C, when release member 1100 moves to the left, index ring 500 is rotated. Note that in Fig. 10C, needle 902 is present, thus showing that the syringe 900 has advanced due to movement of plunger rod 1500, which is only possible when clutch 1108 is in the unlocked position).
Regarding claim 5, Bechmann teaches the invention as claimed and as discussed above for claim 1, and Bechmann further teaches (Figs. 6C-6D, 7C, 7E, 7G, 8B-8C, 10B-10C) the clutch (1108) is configured for moving from the second clutch position (unlocked position shown in Fig. 7E) to the first clutch position (locked position shown in Fig. 7C) when the plunger rod (1500) moves distally after medicament delivery (Fig. 6D shows that plunger rod 1500 has moved distally, or up, from the position shown in Fig. 6C) whereby the index ring (500) is rotated from the second rotational position (Figs. 8C and 10C) towards the first rotation position (Figs. 8B and 10B) by distal movement of the one or more release members (1100) – (Fig. 7G shows that release member 1100 has moved distally, or to the right).
Regarding claim 6, Bechmann teaches the invention as claimed and as discussed above for claim 1, and Bechmann further teaches (Figs. 7M-7N) the clutch (for this claim, the clutch will include both locking members 1108 and 1110) is a tubular clutch (1108, 1110 is part of 1100, which is tubular) having one or more clutch tabs with a first rotation surface and a second rotation surface (see annotated Figs. 7M-7N on next page. Note that there will be two rotation surfaces, one for each locking member 1108 and 1110), and wherein the internal injector parts comprises a proximal chassis part (1400) having a clutch coupling part with one or more first coupling surfaces and one or more second coupling surfaces (see annotated Figs. 7M-7N on next page. Note that there will be two coupling surfaces, one for each locking member 1108 and 1110), wherein:
when the second rotation surface on the clutch (1108, 1110) is abutting the second coupling surfaces on the clutch coupling part, the clutch is in the second clutch position (as shown in annotated Fig. 7N on next page. Note that when the clutch deflects radially outward into window 1420, 1422, the second rotation surface will contact the second coupling surface); and
when the second rotation surface on the clutch (1108, 1110) is not in contact with the second coupling surfaces on the clutch coupling part, the clutch is in the first clutch position (in Fig. 7M, the second rotation surface will not be in contact with the second coupling surface).
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Regarding claim 7, Bechmann teaches the invention as claimed and as discussed above for claim 6, and Bechmann further teaches (Figs. 7M-7N) the plunger rod (1500) is configured for moving in the longitudinal direction relative to the clutch (1108, 1110), wherein the clutch (1108, 1110) is configured for:
moving proximally (to the left) with the one or more release members (1100) before the second rotation surface comes into contact with the second coupling surfaces (Fig. 7M shows the position before the two surfaces contact; Fig. 7N show the position where the two surface contact);
axial rotation when the second rotation surface comes into contact with the second coupling surfaces (col. 24, ll. 9-11), thereby moving from the first clutch position to the second clutch position (1100, which comprises clutch 1108 and 1110, must be rotated to the position shown in Fig. 7N).
Regarding claim 8, Bechmann teaches the invention as claimed and as discussed above for claim 6, and Bechmann further teaches (Fig. 7N) the clutch coupling part (1071) comprises a clutch stopping surface (see annotated Fig. 7N below) abutting the clutch (1108, 1110) when the clutch (1108, 1110) is in the second clutch position thereby preventing the clutch (1108, 1110) and the one or more release members (1100) from moving longitudinally with the plunger rod (1500) – (once clutch 1108, 1110 has deflected radially outward, the clutch and the release member 1100 will not move longitudinally with plunger rod 1500).
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Regarding claim 9, Bechmann teaches the invention as claimed and as discussed above for claim 6, and Bechmann further teaches (Fig. 7M) the plunger rod (1500) comprises a stopping clutch tab (1508), wherein a distal surface (1509) of the stopping clutch tab (1508) is abutting a proximal surface (1109) of the one or more release members (1100) when the clutch (1108, 1110) is in the first clutch position (as shown in Fig. 7M).
Regarding claim 10, Bechmann teaches the invention as claimed and as discussed above for claim 9, and Bechmann further teaches (Figs. 7M-7N) the stopping clutch tab (1508) is configured for moving the clutch (1108, 1110) from the second clutch position (Fig. 7N, after plunger rod 1500 has been disconnected from release member 1100) to the first clutch position (Fig. 7M) upon distal movement (to the right) of the plunger rod (1500) bringing the distal surface (1509) of the stopping clutch tab (1508) in contact (as shown in Fig. 7M) with the proximal surface (1109) of the one or more release members (1100) – (col. 24, ll. 9-11 discusses rotating and retracting release member 1100 with plunger rod 1500 to the same initial position shown in Fig. 7A).
Regarding claim 11, Bechmann teaches the invention as claimed and as discussed above for claim 1, and Bechmann further teaches (Figs. 1 and 4A-4C) the injector (10) comprises one or more cassette interacting parts (1400 and 1402 – Fig. 4C) configured for engaging in a snap-fit connection (col. 20, ll. 13-15: “ring snap mechanism”) with corresponding one or more cassette securing tabs (inherent in a ring snap mechanism) on the cassette (100) when the cassette (100) is inserted into the injector (in this case, cassette 100 is inserted into handle top 1800, which is part of injector 10), and wherein proximal movement (to the left) of the release member (1100 – Fig. 1) prevents a disengagement of the snap-fit connection thereby securing the cassette (100) inside the auto injector (10) – (intended use. The disengagement of the snap-fit connection requires a rotational force on either casing 100 or handle top 1800 (see col. 20, ll. 19-25). Movement of release member 1100 will not disengage the snap-fit connection).
Regarding claim 12, Bechmann teaches the invention as claimed and as discussed above for claim 1, and Bechmann further teaches (Figs. 1 and 10) a system for administering a medicament, the system comprising a reusable auto injector (10 – col. 18, l. 25) according to claim 1 and a disposable cassette (Fig. 1: comprising 100, 500, 600, and 800) extending in a longitudinal direction (Fig. 1: left/right) from a proximal end (Fig. 1: left end of 100) to a distal end (Fig. 1: right end of 800), the cassette (100, 500, 600, 800) comprising:
a syringe holder (800) for receiving a syringe (900) containing the medicament;
a skin sensor (600) longitudinally movable relative to the syringe holder (800) between a plurality of longitudinal positions (col. 19, ll. 25-28) including at least a proximal longitudinal position (Fig. 2B); and a distal longitudinal position (Fig. 2C);
an index ring (500) rotatable relative to the skin sensor (600) between a plurality of rotational positions (col. 24, l. 67 – col. 25, l. 2) including at least a first rotational position (Figs. 8A) in which the skin sensor (600) is prevented from moving distally (col. 24, ll. 59-62); and a second rotational position (Figs. 8B-8C) in which the skin sensor (600) is moveable between the distal longitudinal position (Fig. 2C) and the proximal longitudinal position (Fig. 2B);
wherein the rotational position of the index ring (500) is configured to be controlled by one or more release members (1100) in the auto injector (10) when the cassette (100, 500, 600, 800) is secured in the auto injector (10) – (Fig. 10 shows various positions of release member 1100 that controls the rotational position of index ring 500).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bechmann (US 9,186,459 B2: IDS reference), in view of Daniel (US 2020/0078529 A1: IDS reference).
Regarding claim 13, Bechmann teaches the invention as claimed and as discussed above for claim 1, and Bechmann further teaches (Figs. 1-2C) a system for administering a medicament, the system comprising a reusable auto injector (10 – col. 18, l. 25) according to claim 1 and a disposable cassette (Fig. 1: comprising 100, 500, 600, 800, and 1800) extending in a longitudinal direction (Fig. 1: left/right) from a proximal end (Fig. 1: left end of 100) to a distal end (Fig. 1: right end of 800), the cassette (100, 500, 600, 800, 1800) comprising:
a syringe holder (800) for receiving a syringe (900) containing the medicament;
a skin sensor (600) comprising cap holding means (see annotated Fig. 1 on next page) at a proximal end (Fig. 1: right end of 600) of the skin sensor (600);
a cassette housing (1800 – Figs. 2A-2C) comprising a cap holding part (1400 – Figs. 2B-2C) at a proximal end (left end) of the cassette housing (1800); and
a removable cassette cap (100) comprising one or more locking cap parts (see annotated Fig. 2B on page 21) extending distally from a proximal end (left end) of the cassette cap (100),
wherein the skin sensor (600) is longitudinally movable relative to the syringe holder (800) between at least an initial locked position (Fig. 2C) and an intermediate position (Fig. 2B) being proximal (Fig. 2: to the right) of the initial locked position (Fig. 2C),
wherein upon proximal movement of the skin sensor (600) from the initial locked position (Fig. 2C) to the intermediate position (Fig. 2B), the distal locking ends (708) moves outside the cassette housing.
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However, Bechmann does not teach wherein prior to use, a cassette cap locking protrusion on each of the one or more locking cap parts is secured inside the cassette housing.
It is noted that Bechmann teaches that the removable cassette cap (100) is coupled to the cassette housing (1800) via a ring snap mechanism (col. 20, ll. 13-15).
Daniel teaches (Figs. 2A and 4) a similar system comprising a reusable auto injector (100) and a disposable cassette (comprising 132 and 102), the cassette comprising:
a cassette housing (102 – Fig. 2A) comprising a cap holding part (see annotated Fig. 4 on next page) at a proximal end (left end) of the cassette housing (102); and
a removable cassette cap (132) comprising one or more locking cap parts (see annotated Fig. 2A on next page) extending distally from a proximal end (left end) of the cassette cap (132),
wherein prior to use, a cassette cap locking protrusion (see annotated Fig. 2A on next page) on each of the one or more locking cap parts is secured inside the cassette housing (120) – (as shown in annotated Fig. 2A on next page).
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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 Bechmann by replacing the ring snap mechanism with the locking mechanism of Daniel comprising a cassette cap locking protrusion on each of the one or more locking cap parts that is secured inside the cassette housing, because it has been held that a simple substitution of one known element (in this case, the ring snap mechanism of Bechmann) for another (in this case, a locking mechanism comprising a cassette cap locking protrusion on each of the one or more locking cap parts that is secured inside the cassette housing, as taught by Daniel) to obtain predictable results (in this case, to provide a similar locking mechanism for securing the removable cassette cap to the cassette housing) was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I)(B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached form PTO-892 “Notice of References Cited”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
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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.
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/HENRY NG/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
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