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 . Claims 1-6, 8-9, 11-14, and 16-23 of the amended claim set received 1/25/2024 are pending.
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: “rotation inhibiting formation” in claim 1.
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 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.
Claim 13 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 13 recites, “the dial member and the chamber body element are connected in a torque proof manner.” It is unclear what is required of two elements connected in a torque proof manner therefore the metes and bounds of the claimed structure cannot be determined. The claim is examined as best understood.
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.
(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.
Claims 1-5, 8-9, 11-13, and 16-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Knauer (US 2001/0037087).
Regarding Claim 1, Knauer discloses in Figs. 3-7, a medical delivery device, comprising
a barrel assembly 402+408 with a hollow interior and a first thread arrangement (helical slots of barrel assembly portion 408 discussed at para. 0030 and shown in Figs. 4 and 5),
a rod assembly 301+409 with a second thread arrangement 409 and a plunger rod element 301 having a longitudinal axis and extending into the hollow interior of the barrel assembly (see e.g. Fig. 6), and
a dosage chamber 302 formed in the hollow interior of the barrel assembly with a variable volume limited by the plunger rod element 301 of the rod assembly, and
a rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030),
wherein the barrel assembly and the rod assembly are rotatable relative to each other, and wherein the first thread arrangement of the barrel assembly and the second thread arrangement of the rod assembly engage such that rotation of the barrel assembly and the rod assembly relative to each other moves the rod assembly along the longitudinal axis of its plunger rod element causing the volume of the dosage chamber to vary (as read in para. 0030),
wherein the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) is coupled to at least one of the barrel assembly and the rod assembly (to the barrel assembly portion 408 as read at para. 0034),
wherein the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) defines an extra rotation resistance affecting rotation of the barrel assembly and the rod assembly relative to each other (in a conventional manner, ratcheting will present an additional rotation resistance).
Regarding Claim 2, Knauer further discloses wherein the barrel assembly and the rod assembly define an intrinsic rotation resistance affecting rotation of the barrel assembly and the rod assembly relative to each other (the pins passing through the helical channel as read at para. 0030), and wherein a total rotation resistance being the sum of the intrinsic rotation resistance and the extra rotation resistance (the ratcheting action) has to be overcome to rotate the barrel assembly and the rod assembly relative to each other.
Regarding Claim 3, Knauer further discloses wherein the total rotation resistance defines a resistance force acting on the rod assembly, wherein, when linearly moving the plunger rod element 301 of the rod assembly by rotating the barrel assembly (portion 408) and the rod assembly relative to each other to increase the volume of the dosage chamber, a negative pressure is generated in the dosage chamber which defines a pulling force acting on the rod assembly (force is intrinsically there going from, e.g., Fig. 4 to Fig. 5), and wherein the rotation inhibiting formation is configured such that the resistance force is higher than the pulling force.
Regarding Claim 4, Knauer further discloses wherein the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) is configured such that a relative movement between the rod assembly and the barrel assembly is prevented when varying the volume of the dosage chamber is stopped (as read at the last sentence of para. 0030).
Regarding Claim 5, Knauer discloses wherein the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) comprises protrusions (i.e. ratchets) configured to increase friction upon rotation of the barrel assembly and the rod assembly relative to each other (every time a ratchet is encountered, friction is produced).
Regarding Claim 8, Knauer discloses wherein the protrusions (herein defined as 407) abut the barrel assembly 402+408 (see Fig. 5) and wherein the barrel assembly and the protrusions are rotatable relative to each other (read para. 0030).
Regarding Claim 9, Knauer discloses wherein the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) comprises counter-protrusions (ratchet portions on 408) configured to interact with the protrusions 407 upon rotation of the barrel assembly and the rod assembly relative to each other, wherein the barrel assembly is equipped with the counter-protrusions (ratchet portions on 408).
Regarding Claim 11, Knauer discloses wherein the barrel assembly comprises a dial member 411 (see Figs. 3 and 5) accessible from outside the medical delivery device to rotate the barrel assembly relative to the rod assembly (read para. 0030).
Regarding Claim 12, Knauer discloses wherein the barrel assembly 402+408 comprises a chamber body element 402 having the hollow interior (see e.g. Fig. 7).
Regarding claim 13, Knauer discloses wherein the barrel assembly 402+408+411 comprises a chamber body element 402 having the hollow interior (see Fig. 7) and wherein the dial member 411 and the chamber body element 402 are connected in a torque proof manner (connected as shown in Fig. 5), when the medical delivery device is arranged to rotate the barrel assembly and the rod assembly relative to each other.
Regarding Claim 16, Knauer discloses a housing part 412+413 (see Fig. 3) housing the barrel assembly 402+408 and the rod assembly 301+409, wherein the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) has a housing friction increasing member 407 arranged to increase friction between the housing part 412+413 and at least one of the barrel assembly 402+408 (the ratcheting action as described in para. 0030) and the rod assembly.
Regarding Claim 17, Knauer discloses wherein the housing part, the rod assembly or the barrel assembly is equipped with the housing friction increasing member 407 (the housing part 412+413 as shown in Fig. 7).
Regarding Claim 18, Knauer discloses wherein the plunger rod element 301 comprises a stopper member 303 arranged in the hollow interior of the barrel assembly 402+408 (see Fig. 5).
Regarding Claim 19, Knauer discloses wherein the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) is configured to define the extra rotation resistance such that the barrel assembly 402+408 and the rod assembly 301+409 are manually rotatable relative to each other against the extra rotation resistance (as read in para. 0030).
Regarding Claim 20, Knauer discloses wherein the barrel assembly , the rod assembly 301+409 and the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) are configured to define the total rotation resistance such that the barrel assembly 402+408 and the rod assembly are manually rotatable relative to each other against the total rotation resistance (as read in para. 0030).
Regarding Claim 21, Knauer discloses wherein the rotation inhibiting formation (407 or the mating rachets on barrel assembly portion 408 as read in para. 0030) is configured to provide the extra rotation resistance (in a conventional manner, ratcheting will present an additional rotation resistance) during rotation of the barrel assembly and the rod assembly relative to each other.
Claim 1 and 22-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gaillot (US 2018/0369492).
Regarding Claim 1, Gaillot discloses in Fig. 17, a medical delivery device, comprising
a barrel assembly 60 with a hollow interior 610 (see Fig. 22) and a first thread arrangement 650,
a rod assembly 30 with a second thread arrangement 3330 and a plunger rod element 310 having a longitudinal axis and extending into the hollow interior of the barrel assembly (see e.g. Fig. 18), and
a dosage chamber 6110 (see Fig. 22) formed in the hollow interior 610 of the barrel assembly with a variable volume limited by the plunger rod element 310 of the rod assembly, and
a rotation inhibiting formation 3340,
wherein the barrel assembly and the rod assembly are rotatable relative to each other, and wherein the first thread arrangement of the barrel assembly and the second thread arrangement of the rod assembly engage such that rotation of the barrel assembly and the rod assembly relative to each other moves the rod assembly along the longitudinal axis of its plunger rod element causing the volume of the dosage chamber to vary (as read in para. 0166),
wherein the rotation inhibiting formation 3340 is coupled to at least one of the barrel assembly 60 and the rod assembly 30 (coupled to each as shown in Fig. 18),
wherein the rotation inhibiting formation 3340 defines an extra rotation resistance affecting rotation of the barrel assembly and the rod assembly relative to each other (as shown in Fig. 18, 3340 is pressed against 60 such that when 60 is rotated, additional frictional resistance formed).
Regarding Claims 22 and 23, Gaillot discloses in Fig. 18, a delivery needle 620 and a vial spike 5260 configured to pierce a cover of a vial, wherein in a dosing status (Fig. 22) a fluid passageway is established through the vial spike and elivery needle into the hollow interior 610 of the barrel assembly 60; wherein in the dosing status the delivery needle 620 extends into the vial spike 5260 (see how the arrangement in Fig. 18 mirrors that of Fig. 11 of the instant action; read para. 0167).
Allowable Subject Matter
Claims 6 and 14 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not disclose or form a reasonable combination teaching the following in combination with the limitations of the base claim and any intervening claims -
Regarding Claim 6, “wherein the rotation inhibiting formation comprises a bearing member equipped with the protrusions and wherein the bearing member is sleeve-shaped and the protrusions form an axial end of the bearing member.”
Regarding Claim 14, “wherein a first one of the first thread arrangement of the barrel assembly and the second thread arrangement of the rod assembly has a thread and a second one of the first thread arrangement of the barrel assembly and the second thread arrangement of the rod assembly has an engaging element configured to engage the thread, and wherein the rotation inhibiting formation has an engagement friction increasing member and the engaging element is equipped with the engagement friction increasing member.”
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found in the attached Notice of References Cited.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE D FORD whose telephone number is (571)272-8140. The examiner can normally be reached on M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached on (571) 270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.D.F/Examiner, Art Unit 3741
/PHUTTHIWAT WONGWIAN/Supervisory Patent Examiner, Art Unit 3741
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