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 .
Election/Restrictions
Applicant’s election of Invention II drawn to claims 12-15, in the reply filed on 10/23/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claims 13-22 are objected to because of the following informalities: Claims 13-22 should include a comma after the dependent claim number. Claim 20 should read “a retrieval feature extending from an end thereof” on lines 1-2. Appropriate correction is required.
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.
Claim(s) 12, 14-15, 18, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0264241 A1 to Plance et al.
In regard to claim 12:
A method for intranasal delivery of a medicinal substance (Para. 68. Fig. 2, Fig. 4 element 106, Fig. 15 element 128) comprising: (a) obtaining a sealed container that includes an insert member in a container interior thereof (Fig. 18, para. 97), wherein the first insert member comprises an absorbent material and includes a medicinal substance contained therein (Para. 93, “active ingredient” considered to be medicinal substance. Figs. 20-29); (b) opening the package to expose the insert member (Fig. 17, Paras. 94, 176), wherein the insert member is at least partially saturated with the medicinal substance (Fig. 17, Para. 93-94); (c) inserting the insert member into a nostril of a user such that the insert member contacts an inner surface of the nasal cavity (Fig. 2, para. 178); (d) allowing the insert member to remain in the nostril for a predetermined period of time sufficient to permit at least a portion of the medicinal substance to be transferred to the inner surface of the nasal cavity (Paras. 159, 161, 166-167, 175-180); and (e) removing the insert member from the nostril after the predetermined period of time (para. 175-180).
In regard to claim 14:
The method of claim 12 wherein the first insert member includes a main body portion that defines a first axis and has a generally cylindrical shape (Fig. 15 elements 158, 156, 154, 160, 164, 148), wherein at least a first tunnel (Fig. 16 element 150) is defined through the main body portion between a top surface (Fig. 15 end opposite element 164) and a bottom surface of the main body portion (Fig. 15 end with element 164).
In regard to claim 15:
The method of claim 14 wherein the first tunnel extends axially through the main body portion (Fig. 16 element 150).
In regard to claim 18:
The method of claim 14 wherein the first tunnel includes an inner surface (Para. 92. Fig. 16 element 150), and wherein the medicinal substance is included on the inner surface of the first tunnel (Para. 92. Fig. 16 element 150).
In regard to claim 20:
The method of claim 12 further comprising a retrieval features extending from an end thereof (Fig. 15 elements 162 and 164), and wherein the step (e) includes grasping the retrieval feature prior to removing the insert member from the nostril after the predetermined period of time (Fig. 4 element 106. Elements 162 and 164 considered to be retrieval features as they extend outside the users nose to facilitate griping during the removal process. Paras. 106 and 180).
In regard to claim 21:
The method of claim 12 wherein the medicinal substance is a cold medication, flu medication, decongestant, antihistamine, corticosteroid, numbing agent, soothing agent, vasodilator or peptide (Figs. 20-29 and 56-158 demonstrate various medicinal substances reading upon these limitations. Fig. 20 demonstrates different soothing agents, cold/flu medication (cinnamon), antihistamine (rosemary), and vasodilator (chamomile), Fig. 57 soothing agent (cannabis). Examiner notes non-exhaustive list due to the volume of active agents taught by Plance and more may be listed para. 62).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0264241 A1 to Plance et al. in view of US 2019/0290865 A1 to Fahey et al.
In regard to claim 13:
The method of claim 12 taught by Plance as described in parent claim rejection.
Plance teaches that there is a predetermined period of time (Para. 166-167). However, Plance does not explicitly disclose the predetermined period of time is more than thirty seconds. Fahey teaches, wherein the predetermined period of time is more than thirty seconds (Para. 56 “several minutes”).
It would have been obvious to one having ordinary skill in the art prior to the effective date of filing, to modify the predetermined period of time taught by Plance to be more than thirty seconds as taught by Fahey. This would have been motivated by Plance para. 166 teaching “gentler longer inhalation infusion time” not disclosing what a longer inhalation infusion time is would have led one of ordinary skill in the art to find a time longer than and compared to misting inhalers.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0264241 A1 to Plance et al. in view of US 2,737,953 to R. Wiltein
In regard to claim 16:
The method of claim 14 taught by Plance as described in parent claim rejection.
Plance teaches in para. 84 delivering multiple active ingredients but does not explicitly disclose the second tunnel as claimed. Wiltein teaches, wherein a second tunnel is defined through the main body portion between the top surface and the bottom surface of the main body portion (Fig. 3 elements 13 (First tunnel) and 14 (Second tunnel)).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify the main body taught by Plance to include the second tunnel as taught by Wiltein. This would have been motivated by Plance’s teaching of delivery multiple active ingredients at the same time (Para. 84). Wiltein demonstrates one such arrangement of multiple tunnels and one of ordinary skill in the art would have recognized as capable of delivering multiple active ingredients.
In regard to claim 17:
The method of claim 16 taught by Plance as described in parent claim rejection.
Plance doesn’t teach the second tunnel is offset as claimed. Wiltein teaches, wherein the second tunnel is offset from the first axis (Fig. 3 elements 13 (First tunnel) and 14 (Second tunnel) offset from the first axis).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filling, to modify main body taught by Plance to include the second tunnel offset from the first axis as taught by Wiltein. This would have been motivated by duplication of parts. It is considered to be within the level of ordinary skill in the art to duplicate the tunnel to have a second tunnel as this is known configuration as taught by Wiltein.
Claim(s) 19 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0264241 A1 to Plance et al. in view of US 2004/0198822 A1 to Fraser et al.
In regard to claim 19:
The method of claim 12 taught by Plance as described in parent claim rejection.
Plance doesn’t teach the hydrophilic matrix as claimed. Fraser teaches, wherein the insert member comprises a hydrophilic matrix configured to absorb and retain the medicinal substance (Para. 300 specifically the matrix formulated of hydrophilic polymer).
Fraser is considered analogous art as working on the same problem extended drug release.
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the insert member material to be a hydrophilic matrix. This would have been motivated by improving the absorption and retention of water based active agents and/or drugs.
In regard to claim 22:
The method of claim 12 taught by Plance as described in parent claim rejection.
Plance teaches, wherein the insert member includes a main body portion that defines a first axis, has a generally cylindrical shape (Fig. 15 elements 158, 156, 154, 160, 164, 148) and wherein at least a first tunnel (Fig. 16 element 150) is defined through the main body portion between a top surface (Fig. 15 end opposite element 164) and a bottom surface of the main body portion (Fig. 15 end with element 164)., wherein the first tunnel includes an inner surface (Para. 92. Fig. 16 element 150), and wherein the medicinal substance is included on the inner surface of the first tunnel (Para. 92. Fig. 16 element 150).
Plance doesn’t teach the hydrophilic matrix as claimed. Fraser teaches, comprises a hydrophilic matrix configured to absorb and retain the medicinal substance (Para. 300 specifically the matrix formulated of hydrophilic polymer).
Fraser is considered analogous art as working on the same problem extended drug release.
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the insert member material to be a hydrophilic matrix. This would have been motivated by improving the absorption and retention of water based active agents and/or drugs.
Conclusion
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/M.A.I./Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783