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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/06/2025 and 02/02/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of 1-4, 16-20 and 34 in the reply filed on 03/12/2026 is acknowledged. The traversal is on the ground(s) that claims 1 and 19 are amended to recite that the drug holder is configured to move in a proximal direction during first stage of operation and second stage of operation. This is not found persuasive because the first and second stop members do not relate to a single general inventive concept.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 5-15 and 21-33 have been withdrawn.
Response to Amendment
This office action is responsive to the amendment filed on 03/12/2026. As directed by the amendment: claims 1 & 19 have been amended.
Thus, claims 1-34 are pending in this application with claims 5-15 and 21-33 being withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference number 238 in figures 10, 11, and 12 is not in the description.
Reference number 316b in figure 18 is not in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Reference number 314b in para 0099 and 0100 is not the drawing.
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.
Specification
The disclosure is objected to because of the following informalities:
Para 0068, line 10, “device indicator 110” should read “device indicator 116”.
Para 0092, lines 7 and 9, “user’s hand 236” should read “user’s hand 238”.
Para 0107, line 15, “the pad 408” should read “the pad 608”.
Para 0117, line 7, “collar 1118” should read “collar 1116”.
Para 0118, line 7, “pen rotaton mechanism” should read “pen rotation mechanism”.
Para 0122, lines 3 and 4, “the first magnet 908” should read “the first magnet 904”.
Para 0122, line 6, “second magnet 910” should read “second magnet 906”.
Para 0123, line 4, “second magnet 910” should read “second magnet 906”.
Appropriate correction is required.
Claim Objections
Claims 2-4, 16, 17, 20 and 34 are objected to because of the following informalities:
Claims 2-4, 16 and 17, line 1, “the system of claim 1” should read “the drug delivery system of claim 1”.
Claims 20 and 34, line 1, “the method of claim 19” should read “the drug delivery method of claim 19”.
Claim 19, line 4, “such as a first amount” should read “such as the first amount”.
Claim 19, line 9, “such as a second amount” should read “such as the second amount”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 16-20 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 19 recite “the second stop member is offset from the first stop member in the proximal direction”, the specification fails to clearly describe the limitation, thus this limitation is considered to be new matter as it is not supported by the specification.
By virtue of dependency, claims 2-4, 16-18, 20 and 34 are also rejected.
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 18 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 18 recites “A drug product disposed in the system of claim Error! Reference source not found” in lines 1-2. Examiner is unsure whether claim 18 depends on the system of claim 1 or any preceding claims. For the purpose of compact prosecution, examiner is interpreting claim 18 as a dependent of claim 1.
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.
Claims 1, 16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Le Maner et al (US 20160068326 A1).
Regarding claim 1, Le Maner et al disclose a drug delivery system (figs 1-3, abstract), comprising: a dispensing head (30) including a tip (tip of 30) configured to be positioned in a nose of a patient (para 0023 and 0037), the tip having an opening (31) therein, a drug holder (10) containing a drug (abstract and para 0022) therein; a first stop member (51); and a second stop member (52); wherein: the drug holder (10) is configured to move a first amount in a proximal direction relative to the dispensing head in a first stage of operation in which the drug is delivered from the drug holder and out of the opening (fig 2, para 0028-29); the drug holder is configured to move a second amount in a proximal direction relative to the dispensing head in a second stage of operation in which the drug is delivered from the drug holder and out of the opening (fig 3, para 0029-30); the first stop member (51) is configured to mechanically stop movement of the drug holder relative to the dispensing head between the first and second stages of operation (fig 2, shoulder 51 acts as a stopper until actuating again, para 0028-29); and the second stop member (52) is offset from the first stop member (51) in the proximal direction and is configured to mechanically stop movement of the drug holder relative to the dispensing head after the second stage of operation (fig 3, shoulder 52 acts a stopper after the second has been dispensed, para 0030).
Regarding claim 16, Le Maner et al disclose the system of claim 1, further comprising a viewing window (35, 36) configured to allow a user to visualize whether or not each of the first and second stages of operation have occurred (para 0031 and 0034-38).
Regarding claim 19, Le Maner et al disclose a drug delivery method (figs 1-3), comprising: actuating (60) a nasal drug delivery device in a first stage of operation to cause a drug holder to move in a proximal direction a first amount relative to a dispensing head (30) of the drug delivery device such that a first amount of drug in a drug holder (10) exits into a nose through an opening (31) formed in the dispensing head (fig 2, para 0028-29), a first mechanical stop member (51) of the drug delivery device engaging at an end of the first stage of operation (fig 2); and after the first stage of operation, actuating the drug delivery device in a second stage of operation to cause the drug holder to move in the proximal direction relative to the dispensing head a second amount such that a second amount of the drug in the drug holder exits into the nose through the opening (fig 3, para 0029-30), a second mechanical stop member (52) of the drug delivery device engaging at an end of the second stage of operation (fig 3), the second mechanical stop member (52) being offset from the first mechanical stop member (51) in the proximal direction (figs 1-3).
Claim Rejections - 35 USC § 103
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 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.
Claims 17, 18 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Le Maner et al (US 20160068326 A1) in view of Savmarker et al (US 20220087938 A1).
Regarding claim 17, Le Maner et al disclose the limitations of claim 1 but fail to teach wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan.
However, Savmarker et al disclose a drug delivery system wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan (para 0189 and 0243).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the drug delivery system of Le Maner et al wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan as taught by Savmarker et al. This would provide the benefit of having drugs that may have biological activities that include analgesic, sedative and antidepressant functions (para 0189).
Regarding claim 18, Le Maner et al disclose the limitations of claim 1 but fail to teach wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan.
However, Savmarker et al disclose a drug delivery system wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan (para 0189 and 0243).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the drug delivery system of Le Maner et al wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan as taught by Savmarker et al. This would provide the benefit of having drugs that may have biological activities that include analgesic, sedative and antidepressant functions (para 0189).
Regarding claim 34, Le Maner et al disclose the limitations of claim 19 but fail to teach wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan.
However, Savmarker et al disclose a drug delivery system wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan (para 0189 and 0243).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the drug delivery system of Le Maner et al wherein the drug is one of ketamine, esketamine, naloxone, and sumatriptan as taught by Savmarker et al. This would provide the benefit of having drugs that may have biological activities that include analgesic, sedative and antidepressant functions (para 0189).
Allowable Subject Matter
Claims 2-4 and 20 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.
Regarding claim 2, Le Maner et al disclose the system of claim 1, further comprising an accessory (50) that includes the first stop member (51), that is configured to be releasably coupled to the drug holder during the first stage of operation (fig 2).
Le Maner et al fail to teach/disclose or render obvious “said accessory is configured to be removed from the drug holder between the first and second stages of operation” in addition to other limitations.
Regarding claim 20, Le Maner et al disclose the method of claim 19, wherein an accessory (50) coupled to the drug holder during the first stage of operation includes the first mechanical stop member (fig 2).
Le Maner et al fail to teach/disclose or render obvious “the method further comprises removing the accessory from the drug holder before actuating the drug delivery device in the second stage of operation” in addition to other limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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