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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/18/2023, 6/4/2025, and 12/16/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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:
Injection unit…configured to inject the drug
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.
See par. [0048]-[0049] of the pg-publication
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.
Claims 11 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 11, the claim is rendered indefinite by the limitation “in a case in which” because of the conditional nature of the phrase. It is unclear if the applicant is requiring the limitation or only presenting a conditional option. For the purposes of this action, the claim is interpreted as written in a conditional manner and therefore the claimed limitations are not interpreted as being required. The examiner suggests deleting the phrase “in a case in which” if the limitations are meant to be requirements for the claim.
In further regard to claim 11, there is no antecedent basis for “the permanent magnet” on line and no antecedent basis for “the electrode” on line 7.
In regard to claim 14, the same issues exist as discussed directly above for claim 11.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7, 9-12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Industry-Academic-Cooperation Foundation Gyeongsang National University (KR 10-2019-0122397; hereafter IACF; please refer to English translation copy provided by the applicant on 4/18/2023) in view of Mescher et al. (US 2005/0238506; hereafter Mescher).
In regard to claim 1, IACF discloses a needle-free injector (100; see Fig. 1) comprising: a power supply unit (50); a coil (20) configured to receive current from the power supply unit (see 4th full paragraph of page 6); a drug chamber (30) in which a drug is positioned; a housing (10) connected to the drug chamber (see Fig. 1); a separation membrane (31) configured to separate the housing and the drug chamber; and an injection unit (36, 40) positioned in the drug chamber and configured to inject the drug, wherein the coil (20) is positioned outside the drug chamber (30) (see Fig. 1).
IACF fails to expressly disclose a metal material adjacent to the separation membrane.
In a similar art, Mescher discloses an electromagnetically-actuated flow pump system comprising: a power supply unit (see par. [0054] “power source (not shown) in electric communication with the wire coil”); a coil (135) configured to receive current from the power supply unit (see par. [0054]); a drug chamber (120) in which a drug is positioned (see par. [0021]; the device is configured for drug delivery applications); a housing (170, 172) connected to the drug chamber (see Fig. 1A); a separation membrane (125) configured to separate the housing and the drug chamber (see Fig. 1A); a metal material (145; see par. [0052]; “The actuator…consists essentially of, a material having high magnetic permeability, such as, for example, 416 stainless steel or an iron-cobalt alloy”) adjacent to the separation membrane (see Fig. 1a and par. [0052]), and wherein the coil (135) is positioned outside the drug chamber (120). The metal actuator (145) is physically attached to the membrane (125) and in use, an electric current is conducted through the coil (135) in order to generate a magnetizable force in the magnetizable member (130) to create a moving force on the metal actuator (145) which in turn moves the membrane (125) to create a pumping action (see at least par. [0056]-[0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the separation membrane of IACF with the metal actuator attached to the separation membrane as disclosed by Mescher because the IACF and Mescher elements perform an equivalent function of providing a driving force for drugs and therefore the elements are recognized as equivalents that perform the same function. Substituting the elements would yield predictable results of driving drugs from a chamber and would only involve routine skill in the art.
In regard to claim 2, the combination teaches wherein, when current is applied to the coil by the power supply unit, magnetism is formed by the coil (see page 6, lines 9-33 of IACF and par. [0054]-[0057] of Mescher), and wherein the metal material (145 Mescher incorporated into the system of IACF) and the separation membrane (125 of Mescher incorporated into the system of IACF) move from the housing to the drug chamber (30) by the magnetism, and the drug is injected through the injection unit (36, 40) (see Figure 2 of IACF).
In regard to claim 3, the combination teaches wherein, when the current applied by the power supply unit is cut off, the metal material (145 of Mescher) and the separation membrane (125 of Mescher) are restored to their original positions (via spring 140 of Mescher which can be incorporated; see par. [0055] of Mescher).
In regard to claim 4, the combination teaches wherein the power supply unit applies a pulse current (see par. [0058] and [0062] of Mescher).
In regard to claim 5, the combination teaches wherein the pulse current is pulsed power (see par. [0058] and [0062] of Mescher).
In regard to claim 6, the combination teaches wherein when current is applied by the power supply unit, the coil forms a solenoid electromagnet (see page 6, lines 9-23 of IACF and par. [0054]-[0057] of Mescher).
In regard to claim 7, the combination teaches wherein the metal material is one selected from a permanent magnet and a conductor (see par. [0052] of Mescher).
In regard to claim 9, the combination teaches wherein the coil (135 of Mescher) is positioned under (“under” is a relative term which depends on the orientation of the whole device) the separation membrane (125 of Mescher) and is positioned outside the drug chamber (120) (see Fig. 1a of Mescher).
In regard to claim 10, the combination teaches wherein the metal material is one selected from a permanent magnet and a conductor (see par. [0052] of Mescher).
In regard to claim 11, the combination teaches (see 112 rejection; the limitation is not interpreted as being required), wherein, in a case in which one surface of the metal material is coupled to the separation membrane, when the current is applied by the power supply unit, different poles are respectively formed at one end of the coil relatively close to the separation membrane and the other end of the coil relatively far from the separation membrane, and the permanent magnet moves from the housing to the drug chamber through attractive force acts between the electrode formed at the one end of the coil and an electrode of the metal material such that the drug is injected through the injection unit.
In regard to claim 12, the combination teaches wherein the coil (135 of Mescher) is positioned on the separation membrane (125 of Mescher) and is positioned outside the housing (outside of 172 of Mescher).
In regard to claim 14, the combination teaches (see 112 rejection; the limitation is not interpreted as being required), wherein, in a case in which one surface of the metal material is coupled to the separation membrane, when the current is applied by the power supply unit, different poles are respectively formed at one end of the coil relatively close to the separation membrane and the other end of the coil relatively far from the separation membrane, and the permanent magnet moves from the housing to the drug chamber through repulsive force acts between the electrode formed at the one end of the coil and an electrode of the metal material such that the drug is injected through the injection unit.
In regard to claim 15, the combination teaches wherein the drug contained in the drug chamber (30 of IACF) corresponds to an amount to be injected once (functional limitation; the device is capable of single injection).
In regard to claim 16, the combination teaches wherein, when the current is cut off by the power supply unit, the separation membrane is restored to its original position (via spring 140 of Mescher which can be incorporated; see par. [0055] of Mescher).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over IACF and Mescher and further in view of Angel et al. (US 2003/0083611; hereafter Angel).
In regard to claim 8, the combination fails to disclose or suggest further comprising: a drug supply unit connected to the drug chamber and configured to supply the drug to the drug chamber.
In a similar art, Angel discloses a needleless injector device (10) comprising a drug chamber (12) and an injection unit (13) positioned within the drug chamber (see Figure 1), wherein the drug chamber (12) is in fluid communication with a drug reservoir (14) (see Fig. 1 and par. [0019]), wherein the drug reservoir holds a plurality of doses and allows a desired dose for each individual injection (see par. [0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the teachings of Angel in order to provide a needle-less injector with a plurality of doses such that the injector could be used for multiple injections.
Claim(s) 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over IACF and Mescher in further view of Hunter et al. (US 2007/0191758; hereafter Hunter).
In regard to claim 13, the combination fails to teach wherein the metal material is a permanent magnet.
In a similar art, Hunter discloses an electromagnetic impulse actuator 200 is shown in FIG. 2A. The device 200 includes a magnet assembly 201 defining an annular slotted cavity 214 and a coil assembly 203 slidably disposed therein. The stroke of the coil 203 can be controlled by the lengths of the coil and magnet assembly. Thus, the electromagnetic actuator can be configured to transfer a substantial volume of a substance during a single, sustained stroke. See par. [0069]. Hunter further discloses a magnet assembly 205 including a column of magnets 204A, 204B disposed along a central axis 203. The column of magnets can be created by stacking one or more magnetic devices. For example, the magnetic devices can be permanent magnets. As a greater magnetic field will produce a greater mechanical force in the same coil, thus stronger magnets are preferred. See par. [0071].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the use of permanent magnets as disclosed by Hunter in order to provide a stronger magnetic field that produces a greater mechanical force.
In regard to claim 17, IACF discloses a needle-free injector (100; see Fig. 1) comprising: a power supply unit (50) configured to apply current; a coil (20) configured to form an electromagnet by receiving the current from the power supply unit; a separation membrane (31) adjacent to the coil (see Fig. 1).
IACF fails to disclose a permanent magnet provided between the separation membrane and the coil and positioned on the separation membrane, wherein, when the current is applied by the power supply unit, repulsive force acts between the coil forming the electromagnet and the permanent magnet such that the drug is injected.
In a similar art, Mescher discloses an electromagnetically-actuated flow pump system comprising: a power supply unit (see par. [0054] “power source (not shown) in electric communication with the wire coil”); a coil (135) configured to receive current from the power supply unit (see par. [0054]); a drug chamber (120) in which a drug is positioned (see par. [0021]; the device is configured for drug delivery applications); a housing (170, 172) connected to the drug chamber (see Fig. 1A); a separation membrane (125) configured to separate the housing and the drug chamber (see Fig. 1A); a metal material (145; see par. [0052]; “The actuator…consists essentially of, a material having high magnetic permeability, such as, for example, 416 stainless steel or an iron-cobalt alloy”) adjacent to the separation membrane (see Fig. 1a and par. [0052]), and wherein the coil (135) is positioned outside the drug chamber (120). The metal actuator (145) is physically attached to the membrane (125) and in use, the an electric current is conducted through the coil (135) in order to generate a magnetizable force in the magnetizable member (130) to create a moving force on the metal actuator (145) which in turn moves the membrane (125) to create a pumping action (see at least par. [0056]-[0057]). The magnet (145) is positioned between separation membrane (125) and the coil (135). See Fig. 1A.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the separation membrane of IACF with the metal actuator attached to the separation membrane as disclosed by Mescher because the IACF and Mescher elements perform an equivalent function of providing a driving force for drugs and therefore the elements are recognized as equivalents that perform the same function. Substituting the elements would yield predictable results of driving drugs from a chamber and would only involve routine skill in the art.
The combination still fails to teach that the magnetic actuator (145) is a permanent magnet.
In a similar art, Hunter discloses an electromagnetic impulse actuator 200 is shown in FIG. 2A. The device 200 includes a magnet assembly 201 defining an annular slotted cavity 214 and a coil assembly 203 slidably disposed therein. The stroke of the coil 203 can be controlled by the lengths of the coil and magnet assembly. Thus, the electromagnetic actuator can be configured to transfer a substantial volume of a substance during a single, sustained stroke. See par. [0069]. Hunter further discloses a magnet assembly 205 including a column of magnets 204A, 204B disposed along a central axis 203. The column of magnets can be created by stacking one or more magnetic devices. For example, the magnetic devices can be permanent magnets. As a greater magnetic field will produce a greater mechanical force in the same coil, thus stronger magnets are preferred. See par. [0071].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination with the use of permanent magnets as disclosed by Hunter in order to provide a stronger magnetic field that produces a greater mechanical force.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
Prosecution Insights