7/21DETAILED 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 .
Specification
The disclosure is objected to because of the following informalities: on page 16 lines 1, 2, 7, and 29 and page 15 line 35 “plunger 200” should be corrected to “plunger 300”.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference arrow A has been used to designate both a first direction and a second, opposite, direction. 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. 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.
The drawings are objected to because reference 130 and reference 1, with its arrow, should be present on Fig. 5A, on page 4 of the drawings. 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 2, 4, 8, 11-12, and 19 are objected to because of the following informalities:
Regarding claim 2, both instances of “a thread” should be corrected to “the thread” for claim language consistency.
Regarding claim 4, “claim 3 and” should be corrected to “claim 3,“ for correctness.
Regarding claim 8, “claim 4 and” should be corrected to “claim 4,“ for correctness.
Regarding claim 11, “an outer surface” should be corrected to “the outer surface” for claim language consistency.
Regarding claim 12, “the end” should be corrected to “an end” for claim language consistency.
Regarding claim 19, “a syringe” should be corrected to “the syringe” for claim language consistency.
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.
Regarding the limitation to “drive means,” the claim is construed to cover the corresponding structure described in the specification including a motor (see page 15 line 30 to page 16 line 5) as well as equivalents thereof such as a torsion spring which is known in the art to be an equivalent to an electric motor for use as a drive means in an autoinjector.
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 20-21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the needle" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, claim 20 will be interpreted as dependent on claim 19, which introduces the limitations of “a needle”.
Claim 21 recites the limitation "the bung" and “the cartridge” in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, claim 21 will be interpreted as dependent on claim 19, which introduces the limitations of “a bung” and “a cartridge”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 19, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ekman (US 20130123697 A1).
Regarding claims 1-2, Ekman discloses an auto-injector (abstract) comprising: a housing configured to receive or couple to a syringe (elongated outer casing 2 configured to couple to syringe 3, [0117] & Fig. 1);
a plunger disposed within the housing (lead screw tube 16, [0124] & Fig. 1 and 8);
a drive means configured to rotate the plunger (torsion spring 11, [0126] and [0131] & Fig. 1-8);
a first screw thread arrangement configured to, during an insertion phase, cause axial movement of the plunger upon rotation of the plunger by the drive means (screw tube 16 has a variable pitch, [0128]-[0129] & Fig. 8; “The external lead screw of the lead screw tube 16 has a variable pitch. In the embodiment shown in the figures the pitch is steeper in the proximal part of the external lead screw”; the proximal part of external lead screw of lead screw tube 16 and cam follower tube 13, including one ball bearing 21, is being interpreted as a first screw thread arrangement, [0129]; the proximal part of the external lead screw and cam follower 13 are configured to cause axial movement of screw tube 16, upon rotation of tube 16 caused by torsion spring 11, to drive the syringe 3 forward, [0126]-[0131] & Fig. 1 and 6-9); and
a second screw thread arrangement configured to, during a delivery phase subsequent to said insertion phase, cause axial movement of the plunger upon rotation of the plunger by the drive means (screw tube 16 has a variable pitch, [0128]-[0129] & Fig. 8; “The external lead screw of the lead screw tube 16 has a variable pitch. In the embodiment shown in the figures the pitch is steeper in the proximal part of the external lead screw”; the distal part of external lead screw of lead screw tube 16 and cam follower tube 13, including another ball bearing 21, is being interpreted as a second screw thread arrangement, [0129]; the distal part of the external lead screw and cam follower 13 are configured to cause axial movement of screw tube 16, upon rotation of tube 16 caused by torsion spring 11, to drive medicament M out of syringe 3, [0130]-[0132] & Fig. 1 and 6-11), wherein a thread pitch of the first screw thread arrangement is greater than a thread pitch of the second screw thread arrangement (“The external lead screw of the lead screw tube 16 has a variable pitch. In the embodiment shown in the figures the pitch is steeper in the proximal part of the external lead screw (cf. FIG. 1).”, [0128] & Fig. 8; proximal end is noted as P, see abstract).
Regarding claim 19, Ekman discloses all the limitations of claim 1. Ekman further discloses the auto-injector further comprising a syringe, the syringe having: a cartridge for containing a medicament (syringe 3 having a body for containing medicament M, [0117] and [0126] & Fig. 1); a needle located at a front end of the syringe (needle 4, [0117] & Fig. 1); and a bung located at a rear end of the syringe (stopper 25, [0126] & Fig. 1-10).
Regarding claim 21, as best understood in light of the 112(b) rejection set forth above, Ekman discloses all the limitations of claim 19. Ekman further discloses the auto-injector wherein a front end of the plunger abuts the bung such that forward movement of the plunger causes forward movement of the bung relative to the cartridge (plunger front 23, which is being interpreted as part of tube 16 as plunger front 23 and plunger rear 22 are joined to lead screw tube 16, abuts stopper 25 such that axial movement of screw tube 16 and plunger front 23 causes axially movement of stopper 25 relative to syringe 3, [0126], [0131], and [0136] & Fig. 1-11).
Claim(s) 1, 3-9, and 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Atterbury (US 20200353170 A1).
Regarding claim 1, Atterbury discloses an auto-injector (abstract) comprising: a housing configured to receive or couple to a syringe (lower housing 5, middle housing 6, and upper housing 11 configured to couple to syringe 4, [0045]-[0055] & Fig. 1-2B; alternatively, lower housing 5, middle housing 6, upper housing 11, and retract screw 9 may be interpreted as the housing, Fig. 1-16);
a plunger disposed within the housing (center screw 10, [0042]-[0043] & Fig. 1-2B); a drive means configured to rotate the plunger (power spring 12 causes rotation of center screw 10 with respect to the drive nut 15, [0060]-[0061] & Fig. 6-8, 10, and 12);
a first screw thread arrangement configured to, during an insertion phase, cause axial movement of the plunger upon rotation of the plunger by the drive means (internal threads 30 and external thread 36 are being interpreted as a first screw thread arrangement, [0042]-[0044] and [0060]; “The external threads of the middle screw 36 engage the internal threads 30 of the retract screw 9. When the drive nut 15 spins the middle screw 16, the middle screw 16 spins and extends, guided by the internal threads of the retract screw 30… The double-acting screw mechanism effects insertion and fluid injection. The middle screw 16 has internal threads 37 that engage the threads of the center screw 10. When the middle screw 16, driven by the drive nut 15, spins, the center screw 10 begins to translate in the distal direction… The action of the center screw 10 pushes the syringe 4 until the syringe is fully extended; this is the insertion stage.”, [0060]-[0061] & Fig. 7; threads 30 and 36 cause screw 10 to translate distally to insert syringe 4, with screw 10 rotating relative to drive nut 15); and
a second screw thread arrangement configured to, during a delivery phase subsequent to said insertion phase, cause axial movement of the plunger upon rotation of the plunger by the drive means (threads on the outside of screw 10 and internal threads 37 are being interpreted as a second screw thread arrangement, [0043] and [0061] & Fig. 1-2B and 9; “Once the syringe has reached full extension, the continued action of the center screw 10 pushes the plunger 7, causing the fluid contents in the syringe 4 to empty out of the syringe 4; this begins the injection stage.”, [0061] & Fig. 8; threads 10 and 37 cause screw 10 to translate distally to eject fluid from syringe 4, with screw 10 rotating relative to drive nut 15), wherein
a thread pitch of the first screw thread arrangement is different from a thread pitch of the second screw thread arrangement (“The center screw 10 has a larger pitch than the external threads of the middle screw 36”, [0061] & Fig. 1-2B and 7-9).
Regarding claim 3, Atterbury discloses all the limitations of claim 1. Atterbury further discloses the auto-injector wherein a first thread of the first screw thread arrangement is defined by an inner surface of the housing (threads 30 defined by an inner surface of retract screw 9, [0044] & Fig. 1-6) and a second thread of the second screw thread arrangement is defined by an outer surface of the plunger (the threads on the outside surface of screw 10, [0042]-[0043] & Fig. 1-6).
Regarding claim 4, Atterbury discloses all the limitations of claim 3. Atterbury further discloses the auto-injector comprising an insertion collar disposed coaxially around the plunger (middle screw 16 disposed coaxially around screw 10, [0042]-[0043] & Fig. 1-10), wherein the first screw thread arrangement is provided between the housing and the insertion collar (internal threads 30 and external thread 36 are provided between the housing and middle screw 16, [0042] and [0060] & Fig. 1-10), and wherein the second screw thread arrangement is provided between the insertion collar and the plunger (threads on the outside of screw 10 and internal threads 37 are provided between middle screw 16 and screw 10, [0043] and [0061] & Fig. 1-10).
Regarding claim 5, Atterbury discloses all the limitations of claim 4. Atterbury further discloses the auto-injector wherein the first screw thread arrangement comprises one or more first thread engagement features disposed on an outer surface of the insertion collar and configured to engage with the first thread (external threads 36, which being interpreted as one or more first thread engagement features, are disposed on an outer surface of middle screw 16 and are configured to engage internal threads 30, [0042] and [0060]-[0061] & Fig. 1-10).
Regarding claim 6, Atterbury discloses all the limitations of claim 6. Atterbury further discloses the auto-injector wherein the second screw thread arrangement comprises one or more second thread-engagement features disposed on an inner surface of the insertion collar and configured to engage with the second thread (internal threads 37, which being interpreted as one or more second thread engagement features, are disposed on an inner surface of middle screw 16 and configured to engage the thread on screw 10, [0042]-[0043] and [0061] & Fig. 1-10).
Regarding claim 7, Atterbury discloses all the limitations of claim 6. Atterbury further discloses the auto-injector wherein the one or more second thread engagement features comprise one or more flanges extending radially inwards of the inner surface of the insertion collar (internal threads 37 comprise a flange that extends radially inward of the inner surface of middle screw 16, see Fig. 1-10).
Regarding claim 8, Atterbury discloses all the limitations of claim 4. Atterbury further discloses the auto-injector comprising a coupling mechanism (delay nut 17, [0048] & Fig. 6-10) configured to rotationally and axially couple the insertion collar to the plunger during the insertion phase (delay nut 17 is coupled to middle screw 16 and center scree 10, [0048]-[0049] and [0061] & Fig. 6-12; during the insertion stage, nut 17 is configured to axially coupled screw 16 to screw 10 considering nut 17, screw 16, and screw 10 are axially coupled during the insertion stage, [0061]-[0062]; nut 17 may be interpreted as configured to rotationally coupled screw 16 to screw 10 considering nut 17, screw 16, and screw 10 may all be rotated by the user during the insertion stage), wherein the first screw thread arrangement is configured to cause axial movement of the plunger and the insertion collar upon rotation of the plunger by the drive means (internal threads 30 and external threads 36 are configured to extend screw 10 and screw 16 upon rotation of screw 10, facilitated by spring 12, [0060]-[0061] & Fig. 6-8; screw 10 rotating relative to drive nut 15).
Regarding claim 9, Atterbury discloses all the limitations of claim 8. Atterbury further discloses the auto-injector wherein the coupling mechanism is configured to decouple the insertion collar from the plunger at the end of the insertion phase (delay nut 17 is configured to facilitate the decoupling of middle screw 16 and screw 10 after the insertion phase is over, or at the end of the insertion phase, [0061] & Fig. 10; “When the middle screw 16 falls off the threads at the end of the center screw 10, it no longer drives the center screw 10 directly. Instead, the delay nut 17, which is coupled with the middle screw 16 through the damping grease 33 and rotational detent 32, continues to advance the center screw 10.”, [0061]),
wherein the second screw thread arrangement is configured to cause axial movement of the plunger through the insertion collar and the housing upon rotation of the plunger by the drive means (threads on the outside of screw 10 and internal threads 37 are configured to extend screw 10 through middle screw 16 and the housing upon rotation of screw 10 by spring 12, [0061]-[0062] & Fig. 6-10).
Regarding claim 19, Atterbury, as modified, discloses all the limitations of claim 1. Atterbury further discloses the auto-injector further comprising a syringe, the syringe having: a cartridge for containing a medicament (syringe 4 having a body for containing fluid medicine, [0033] & Fig. 1); a needle located at a front end of the syringe (needle 3, [0045]-[0046] & Fig. 1); and a bung located at a rear end of the syringe (plunger 7, [0045] & Fig. 1).
Regarding claim 20, as best understood in light of the 112(b) rejection set forth above, Atterbury, as modified, discloses all the limitations of claim 19. Atterbury further discloses the auto-injector further comprising a retraction spring configured to bias the syringe and/or the needle rearwards (light spring 21 configured to bias syringe 4, and needle 3, rearwards, [0057] & Fig. 1-2A).
Regarding claim 21, as best understood in light of the 112(b) rejection set forth above, Atterbury, as modified, discloses all the limitations of claim 19. Atterbury further discloses the auto-injector wherein a front end of the plunger abuts the bung such that forward movement of the plunger causes forward movement of the bung relative to the cartridge (a front end of screw 10 abuts plunger 7 such that movement of screw 10 causes movement of plunger 7 relative to the body of syringe 4, [0043] and [0061] & Fig. 6-8).
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atterbury (US 20200353170 A1), as applied to claim 8 above, and further in view of Schabbach (US 20210052819 A1).
Regarding claim 14, Atterbury discloses all the limitations of claim 8. However, Atterbury fails to explicitly disclose the auto-injector wherein the drive means comprises a motor, the auto-injector further comprising a controller configured to control the motor to rotate the plunger in a first direction during the insertion phase and the delivery phase.
However, Schabbach teaches an autoinjector ([0049]) wherein the drive means comprises a motor (drive unit 115 comprises an electric motor, [0155] & Fig. 18), the auto-injector further comprising a controller configured to control the motor to rotate the plunger in a first direction during the insertion phase and the delivery phase (“the drive unit comprises an electric motor that is operated to rotate the drive sleeve and thus dispense the medicament from the medicament reservoir.”, [0155]).
Schabbach teaches that “the biasing member 116 is in the form of a torsion spring 116. However, it should be recognized that other types of biasing member are intended to fall within the scope of the disclosure… the biasing member is omitted and instead the drive unit comprises an electric motor that is operated to rotate the drive sleeve and thus dispense the medicament from the medicament reservoir...” ([0155]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the drive means of the autoinjector of Atterbury with Schabbach to include a motor, the auto-injector further comprising a controller configured to control the motor to rotate the plunger in a first direction during the insertion phase and the delivery phase, since Schabbach teaches such to be an art effective equivalent to a torsion spring and would yield the same predictable results pertaining to plunger displacement and fluid delivery ([0155] of Schabbach).
Allowable Subject Matter
Claims 10-13 and 15-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eich (US 20110054412 A1) teaches that a drive element of an autoinjector may be a spring or motor ([0007]). Bar-el (S 20210138157 A1) teaches that an “actuator 14 may take the form of a spring actuator, a gaseous actuator, a chemical actuator, an electrical actuator, an electromechanical actuator, combinations thereof, or the like” ([0018]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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