DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Election/Restrictions
Applicant's election with traverse of group I (claim 1-16 and 32) in the reply filed on 5/18/2026 is acknowledged. The traversal is on the ground(s) that the groups (I and II) include the same technical feature. This is not found persuasive because the office indicated in the previous restriction on 5/12/26 that the groups shared a technical feature however this feature was taught by the 20140276352 reference and therefore it was not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
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.
The following claim limitations
Deployment device (claim 9)
Retrieval device (claim 10)
Deployment/retrieval device (claim 11)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Device (Deployment device - claim 9)
Device (Retrieval device - claim 10)
Device (Deployment/retrieval device - claim 11)
coupled with functional language
is operable for placing the delivery system within the nasal cavity (Deployment device - claim 9)
is operable for removing the delivery system from the nasal cavity (Retrieval device - claim 10)
is operable for placing the delivery system within the nasal cavity and is further operable for removing the delivery system from the nasal cavity (Deployment/retrieval device - claim 11)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 9-11 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
a single component or mechanism such as, for example, a flexible shaft, beam, bar, wire (¶0087) (Deployment device - claim 9)
a single component or mechanism such as, for example, a flexible shaft, beam, bar, wire (¶0094)(Retrieval device - claim 10)
a single component or mechanism such as, for example, a flexible shaft, beam, bar, wire (¶0087/0094)(Deployment/retrieval device - claim 11)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, 9-16, 32, 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20080015540 A1 to Muni et al. (Muni).
Muni discloses:
Regarding claim 1:
A system (figure 11a-11c) comprising:
(a) a reservoir structure (12b) operable for receiving an iontophoretic solution (“iontophoretic delivery of a diagnostic or therapeutic substance”; ¶0159) comprising ions of a therapeutic substance (“for iontophoretic delivery of a diagnostic or therapeutic substance”);
(b) a delivery system (14) comprising a delivery interface (14) configured to be placed in operative apposition with a first side of a tissue surface (“SB” as shown in figure 11c) within a nasal cavity (“EAC” of figure 11c) of a subject (as shown in figure 11), wherein
(i) the delivery system (14) is configured for circulating the iontophoretic solution to the reservoir structure (12b) over a predefined period of time (substance delivered via 12b/28/30 as shown in figure 11B for a period of time);
(c) an electrode device (300/302) comprising a proximal portion (302) and a distal portion (300), wherein
(i) the electrode device (300/302) configured for the proximal portion (302) to be disposed outside of the nasal cavity (“EAC”) (see 302 extends beyond the nasal cavity as shown in figure 11) while the distal portion (300) extends into the nasal cavity (“EAC”) into engagement with a portion of the reservoir structure (12b) (300 is connected to the reservoir structure 12b),
(ii) the electrode device (300/302) further configured for applying a current to the reservoir structure (12b) such that an amount of the ions of the therapeutic substance is delivered to a target area of the subject on a second side of the tissue surface (¶0159 indicates the current is applied for a period of time to deliver the therapeutic substance to the nasal cavity and “SB” and absorbed into “SB” or the second side of “SB”),
(iii) the reservoir structure (12b) configured to maintain the delivery interface (14) against the first side of the tissue surface (“SB) for at least the predefined period of time during which current is being applied by the electrode device (300/302) to the reservoir structure (12b) (the reservoir structure 12b supports 14 against the tissue surface “SB” as shown in figure 11B and 11C), and
(iv) the circulating of the iontophoretic solution replenishes concentration of the ions of the therapeutic substance within the reservoir structure (12b) during the predefined period of time to enhance amounts of the therapeutic substance that are delivered to the target area (the solution flows (circulates) through the reservoir structure 12b to the nasal cavity “EAC” with new iontophoretic solution as indicated in ¶0159).
Regarding claim 2:
The system of Claim 1, wherein the delivery system (14) is configured for circulating the iontophoretic solution having a continuous flow of iontophoretic solution (continuous flow during a period of time from 1 to 30 minutes as indicated in ¶0159 when the electrode 300 receives current).
Regarding claim 3:
The system of Claim 1, wherein the delivery system (14) is configured for circulating the iontophoretic solution having a periodic flow of iontophoretic solution (the flow of the solution ends at some point after use of the device and therefore it is periodic).
Regarding claim 5:
The system of Claim 1, wherein:
(a) the delivery system (14) is configured to provide for the iontophoretic solution to flow into the reservoir structure (12b) at or nearby the tissue surface (“SB”)(as shown in figure 11B the solution is provided to 12b and flows into the tissue surface “SB”); and
(b) the delivery system (14) is configured to provide for the iontophoretic solution to flow away from the reservoir structure (12b) at or nearby the distal portion (300) of the electrode device (flows away from the reservoir structure 12b into the nasal cavity via holes 30 as shown in figure 11b).
Regarding claim 9:
The system of Claim 1 further comprises a deployment device (150/152/154 as shown in figure 2E which ¶0098 indicates can be used to insert 10f via the projections 18) that is capable of being coupled and uncoupled to the delivery system (14), wherein the deployment device is operable for placing the delivery system (14) within the nasal cavity (“EAC”) (as shown in figure 2E).
Regarding claim 10:
The system of Claim 1 further comprises a retrieval device (see the forceps shown in figure 3K for removing the system 14) that is capable of being coupled and uncoupled to the delivery system (14), wherein the retrieval device is operable for removing the delivery system (14) from the nasal cavity (“EAC”).
Regarding claim 11:
The system of Claim 1 further comprises a deployment/retrieval device (device 150/152/154 and forceps shown in figure 3K) that is capable of being coupled and uncoupled to the delivery system (14), wherein the deployment/retrieval device is operable for placing the delivery system (14) within the nasal cavity (“EAC”) and is further operable for removing the delivery system (14) from the nasal cavity (“EAC”).
Regarding claim 12:
The system of Claim 1, wherein the therapeutic substance is selected from a group consisting of analgesics, anesthetics, anti-inflammatories, antibiotics (“antibiotics” as disclosed in ¶0159), antivirals, antifungals, antiparasitics, decongestants, mucokinetics, antihistamines, antioxidants, immunosuppressive agents, dissociatives, steroids, sedatives, hypnotics, anticholinergics, antiemetics, antiepiletics, non-steroidal anti-inflammatory drugs, and combinations thereof.
Regarding claim 13:
The system of Claim 1, wherein the therapeutic substance is a steroid (“steroid” as indicated in ¶0092).
Regarding claim 14:
The system of Claim 1, wherein the iontophoretic solution comprises betamethasone ions (“betamethasone” as indicated in ¶0170).
Regarding claim 15:
The system of Claim 1, wherein the therapeutic substance is an anesthetic (“anesthetic” as indicated in ¶0169).
Regarding claim 16:
The system of Claim 1, wherein the iontophoretic solution comprises lidocaine ions, epinephrine ions, or a combination thereof (“lidocaine” as indicated in ¶0159).
Regarding claim 32:
A system (figure 11a-11c) comprising:
(a) a reservoir structure (12b) operable for receiving an iontophoretic solution (“iontophoretic delivery of a diagnostic or therapeutic substance”; ¶0159) comprising ions of a therapeutic substance (“for iontophoretic delivery of a diagnostic or therapeutic substance”);
(b) a delivery system (14) comprising a delivery interface (14) configured to be placed in operative apposition with a first side of a tissue surface (“SB”) within an interior region (“EAC” of figure 11c) of a subject (as shown in figure 11), wherein
(i) the delivery system (14) is configured for circulating the iontophoretic solution to the reservoir structure (12b) over a predefined period of time (substance delivered via 12b/28/30 as shown in figure 11B for a period of time);
(c) an electrode device (300/302) comprising a proximal portion (302) and a distal portion (300), wherein
(i) the electrode device (300/302) configured for the proximal portion (302) to be disposed outside of the interior region (see 302 extends beyond the nasal cavity as shown in figure 11) while the distal portion (300) extends into the interior region into engagement with a portion of the reservoir structure (12b) (300 is connected to the reservoir structure 12b),
(ii) the electrode device (300/302) further configured for applying a current to the reservoir structure (12b) such that an amount of the ions of the therapeutic substance is delivered to a target area of the subject on a second side of the tissue surface (“SB”) (¶0159 indicates the current is applied for a period of time to deliver the therapeutic substance to the nasal cavity and “SB” and absorbed into “SB” or the second side of “SB”),
(iii) the reservoir structure (12b) configured to maintain the delivery interface (14) against the first side of the tissue surface (“SB”) for at least the predefined period of time during which current is being applied by the electrode device (300/302) to the reservoir structure (12b) (the reservoir structure 12b supports 14 against the tissue surface “SB” as shown in figure 11B and 11C), and
(iv) the circulating of the iontophoretic solution replenishes concentration of the ions of the therapeutic substance within the reservoir structure (12b) during the predefined period of time to enhance amounts of the therapeutic substance that are delivered to the target area (the solution flows (circulates) through the reservoir structure 12b to the nasal cavity “EAC” with new iontophoretic solution as indicated in ¶0159).
Regarding claim 34:
A method, comprising:
delivering a therapeutically effective dose of the therapeutic substance to the target area (¶0159 indicates how the therapeutic substance is delivered to the nasal cavity) of the subject using the system of claim 1 (as shown in the claim 1 rejection above).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080015540 A1 to Muni et al. (Muni) as applied to claim 1 above, and further in view of WO 2012154704 A2 to Imran et al. (Imran).
Regarding claim 6:
Muni fails to disclose:
The system of Claim 1, wherein the electrode device is configured for applying the current utilizing a current profile having a ramp-up period, a steady state period, and a ramp- down period.
Imran teaches:
A transdermal iontophoretic delivery of therapeutic agents method that includes a ramp-up period (808), a steady state period (807), and a ramp-down period (809) as shown in figure 8d. The reference indicates that this method of controlling the power source allows for the user to get physically accustomed to the application of current and delivery of the therapeutic agent (¶064).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Muni to include the electrode device applying the current in the ramp-up period, a steady state period, and a ramp- down period as taught by Imran to allow the user to be better accustomed to the application of current and delivery of the therapeutic agent (Imran, ¶064).
Allowable Subject Matter
Claims 4 and 7-8 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. The following is pertinent prior art:
US-20100069877-A1
Smith
See the electrode 221
WO-9711743-A1
FLOWER
See the electrodes (6/8)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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