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 .
This office action is in response to the preliminary amendment filed 4/11/25 and the election of species of 2/26/26. As directed by the amendment: claims 1-4, 6-8, 10, 12, 14-17, 20, 22, 24-26, and 28-29 have been amended, claims 5, 9, 11, 13, 18-19, 21, 23, 27, and 30 have been cancelled, and no claims have been added. As such and per below, claims 1-4, 6-8, 10, 12, 14-17, 20, 22, 24-26, and 28-29 are pending with claims 14-16 and 24-26 withdrawn from consideration as being directed towards non-elected subject matter and claims 1-4, 6-8, 10, 12, 17, 20, 22, and 28-29 examined below.
Election/Restrictions
Claims 14-16 and 24-26 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/26/26.
Claims 14 is withdrawn as it is directed towards non-elected species S9 and S11-12 covering figures 14 and 16-18 disclosing a supply of agent that is in communication with the delivery means/element, which elected species S8 does not support (fiber-type delivery mechanism 8 with agent thereon and not a separate supply in communication with delivery means/element). Similarly, claims 24-26 are withdrawn as they include a separate supply of agent in communication with the delivery means placed on the substrate, which is not supported by the elected species S8 (fiber-type delivery mechanism with agent thereon and not a separate supply of agent on the substrate/frame in communication therewith).
Drawings
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: 7. 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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Note: the term “comprises” (line 2) is improper language for an abstract; Examiner suggests amending to read –includes--.
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: “delivery element” in claim 1, 3 and “delivery means” in claim 14, 29, 22.
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.
The structural elements for performing the delivery for the above element/means is a layer of fiber material containing agent (Fig. 11-13 for example of the elected species), other agent carrying sleeves, pad, and functional 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.
Claims 1-4, 6-8, 10, 12, 17, 20, 22, and 28 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.
Regarding claim 1, the language “the agent” (line 4-5 and 7) is unclear as it is not known if this is referring to the “agent” in line 1, the medicinal “agent” in line 2 or the therapeutic “agent” in line 2.
Regarding claim 3, the language “the agent” (line 7 and 11) is unclear as it is not known if this is referring to the “agent” in line 1, the medicinal “agent” in line 2 or the therapeutic “agent” in line 2.
Regarding claim 6, the language “the agent” (line 4) is unclear as it is not known if this is referring to the “agent” in claim 1 line 1, the medicinal “agent” in claim 1 line 2 or the therapeutic “agent” in claim 1 line 2.
Regarding claim 8, the language “the agent” (line 7) is unclear as it is not known if this is referring to the “agent” in claim 1 line 1, the medicinal “agent” in claim 1 line 2 or the therapeutic “agent” in claim 1 line 2.
Regarding claim 10, the language “the agent” (line 3 and 5) is unclear as it is not known if this is referring to the “agent” in claim 1 line 1, the medicinal “agent” in claim 1 line 2 or the therapeutic “agent” in claim 1 line 2.
Regarding claim 12, the language “the agent” (line 7) is unclear as it is not known if this is referring to the “agent” in claim 1 line 1, the medicinal “agent” in claim 1 line 2 or the therapeutic “agent” in claim 1 line 2.
Claim 20 recites the limitation "the … frame" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 20, the language “strand-like elements or filaments” (line 3) is unclear as this appears to be a relative term and it is not clear as to what qualifies, or does not qualify, as being ‘strand-like’.
Regarding claim 22, the language “the agent” (line 3) is unclear as it is not known if this is referring to the “agent” in claim 1 line 1, the medicinal “agent” in claim 1 line 2 or the therapeutic “agent” in claim 1 line 2.
Regarding claim 22, the language “strand-like elements or filaments” (line 4) is unclear as this appears to be a relative term and it is not clear as to what qualifies, or does not qualify, as being ‘strand-like’.
Regarding claim 22, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 28, the language “the agent” (line 2) is unclear as it is not known if this is referring to the “agent” in claim 1 line 1, the medicinal “agent” in claim 1 line 2 or the therapeutic “agent” in claim 1 line 2.
Claims 2, 7, 8, 17, and 4 are rejected based on dependency on a rejected claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-7 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 6-7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 6, the language “the delivery element is provided or carried on a surface or region of the at least one frame member that faces the tissue of the lower nasal cavity” (line 5-7) appears to claim the human body, which is non-statutory subject matter. In order for the delivery element to be provided such that it faces the tissue of the lower nasal cavity, the tissue/nasal cavity of the human must be present in the claimed invention. Examiner suggests amending to read --the delivery element is provided or carried on a surface or region of the at least one frame member that faces the tissue of the lower nasal cavity when in use—for example.
Claim 7 is rejected based on dependency on a rejected claim.
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.
(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) 1-2, 6-8, 17, 4, 12, 22, 3, and 29 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Davi (2016/0367773).
Regarding claim 1, Davi discloses an agent delivery device for delivering an agent, optionally a medicinal or therapeutic agent, to an individual (see Fig. 18-25, abstract for example) including a substrate configured to be received and retained or accommodated within a nostril of the individual (see Fig. 19, substrate defined by frame members 38 and 39); and a delivery element provided on and/or carried by the substrate for receiving and delivering the agent such that when the substrate is retained or accommodated within the nostril the delivery element contacts or engages with tissue of the nostril to deliver the agent to the individual (Fig. 18-19, delivery elements 90a and 90b, see para. 0010, 0086-0111, Fig. 17 showing a different embodiment, the embodiment in Fig. 18-25 functioning similar as disclosed).
Regarding claim 2, the Davi device’s substrate forms a frame for supporting the deliver element provided and/or carried thereon (see Fig. 18-19, substrate defined by frame elements 38 and 39 which form a frame for the delivery elements 90a and 90b as shown, see para. 0088), the frame optionally including at least one frame member configured to be received and retained or accommodated within the nostril of the individual and the delivery element provided on/carried by the at least one frame member (these claim limitations are not required by the claims as they are optional; however, elements 38 and 39 each are frame members).
Regarding claim 6, the Davi device’s at least one frame member on which the delivery element is provided or carried is configured to be received and retained or accommodated within a lower nasal cavity for delivering the agent, the frame member formed to complement a surface profile or curvature of the lower nasal cavity and the delivery element provided or carried on a surface or region that faces the tissue of the lower nasal cavity (the frame member is not required by the claims as it is optional per claim 2 and thus the limitations of claim 6 are also optional, however, Fig. 19-20 showing frame members 38 and 39 formed to complement a surface profile or curvature of the nasal cavity as claimed, see Fig. 17 showing another embodiment inserted in the nasal cavity, embodiment of Figs. 18-25 functioning similar as disclosed).
Regarding claim 7, the Davi device’s at least one frame member is both elongate and resiliently flexible and biased into contact with the lower nasal cavity so the delivery element bears against and/or engages with the tissue of the lower nasal cavity when the frame member is accommodated within the nostril (the frame member is not required by the claims as it is optional per claim 2 and thus the limitations of claim 7 are also optional, however, frame members 38 and 39 are elongate as shown, resiliently flexible and biased as claimed, see Fig. 17 showing another embodiment inserted in the nasal cavity, embodiment of Figs. 18-25 functioning similar as disclosed, see para. 0088).
Regarding claim 8, the Davi device’s is such frame includes a pair of frame members each configured to be accommodated within a respective nostril of the individual and include respective delivery element provide on or carried by each of the frame members such that in use the delivery elements bear against or engage with the tissue of the respective nostril to deliver the agent (see Fig. 19, pair of frame members 38 and 39 with respective delivery elements 90a and 90b, Fig. 17 showing another embodiment inserted into and contact tissue of the nasal cavity, embodiment of Figs. 18-25 functioning similar as disclosed, see para. 0088); and/or the pair of or each frame member has a curved or looped configuration (see Fig. 19-20).
Regarding claim 17, the Davi device is such that the frame, or the at least one frame member, is comprised of a plastic material and/or a metal wire; the frame including a handle portion as claimed; and/or a sensory comforter as claimed (see para. 0008, frame/frame members comprised of plastic material).
Regarding claim 4, the Davi device is wearable or configured to be worn by the individual such that the delivery element is received and accommodated within the nostril of the individual for an extended or predetermined period agent delivery time (see Fig. 17 showing another embodiment that is worn by the individual and received/accommodated within the nostril, embodiment of Figs. 18-25 functioning similar as disclosed, see para. 0088).
Regarding claim 12, the Davi device’s delivery element is configured in a form of a pad provided or carried on a respective frame member; and/or including a plurality of micro-needles as claimed (see Fig. 23-24, delivery element including pads 98a, see para. 0092-0096 for example).
Regarding claim 22, the Davi device is such that a delivery means or element is provided on or carried by the substrate or a frame of the device for receiving and delivering the agent includes an open framework and/or an array, web, or mesh of strand-like elements or filaments that preferably include an outer layer or covering on the substrate or frame (see Fig. 22-24, element 91 defining an open framework, para. 0092).
Regarding claim 3, Davi discloses an agent delivery device for delivering an agent, optionally a medicinal or therapeutic agent, to an individual (see Fig. 18-25, abstract for example) including a frame having at least one frame member configured to be received and retained or accommodated within a nostril of the individual (see Fig. 19, frame defined by frame members 38 and 39); a delivery element provided on and/or carried by the at least one frame member for receiving and delivering the agent, optionally in a form of a liquid or gel such that when the frame/frame members are retained or accommodated within the nostril the delivery element contacts or engages with tissue of the nostril to deliver the agent to the individual (Fig. 18-19, delivery elements 90a and 90b, see para. 0010, 0086-0111, Fig. 17 showing a different embodiment, the embodiment in Fig. 18-25 functioning similar as disclosed).
Regarding claim 29, the use of the Davi device includes a method of delivering an agent to an individual nasally (see Fig. 18-25, abstract for example) including the steps of providing an agent delivery device including a frame, at least a part of which is configured to be received and retained within a nostril of the individual (see Fig. 19, frame defined by frame members 38 and 39, Fig. 17 showing another embodiment retained within the nostrils, the embodiment of Figs. 18-25 functioning similar as disclosed), and a delivery means provided on and/or carried by the part of the frame for receiving and delivering the agent (Fig. 18-19, delivery means 90a and 90b, see para. 0010, 0086-0111); introducing the delivery means provided on and/or carried by the part of the frame into the nostril of the individual whereby it is received and retained within the nostril such that the delivery means contacts or engages with an inner surface or tissue of the nostril to deliver the agent (Fig. 18-19, delivery elements 90a and 90b, see para. 0010, 0086-0111, Fig. 17 showing a different embodiment, the embodiment in Fig. 18-25 functioning similar as disclosed); and allowing the delivery means to remain or reside within the nostril for a predetermined period of time for agent delivery (Fig. 18-19, delivery elements 90a and 90b, see para. 0010, 0086-0111, Fig. 17 showing a different embodiment, the embodiment in Fig. 18-25 functioning similar as disclosed, predetermined period of time based on user preference or direction).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davi in view of Altadonna, JR. (2004/0079814).
Regarding claim 10, the Davi device’s delivery element includes a delivery material for receiving and delivering the agent (see Fig. 23-24, delivery materials such as pads 98a membrane 98, see para. 0086-0111), but is silent as to the material being comprised of fibres and/or a polymer foam as claimed (Davi disclosing polymer material, i.e. plastics per para. 0008). However, Altadonna discloses a similar nasal agent delivery device which includes delivery material comprised of fibres and/or foam (see Altadonna para. 0040, absorbent fabric or foam pad). Thus 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 Davi device’s delivery material to be fibres and/or foam, as taught by Altadonna, as this is a well-known type of agent delivery material for containing/delivering agent and would have been obvious substitution of one known element/type of material for another and one would expect the modified Davi device to perform equally as well.
Regarding claim 20, the Davi device’s substrate or frame includes a framework structure including an array, web or mesh (see Davi Fig. 23-24 elements such as 91 defining an open frame work structure and including absorbent pads 98a and membranes 98), but is silent as to the array/web/mesh explicitly including strand-like elements or filaments as claimed. However, Altadonna discloses a similar nasal agent delivery device which includes delivery material comprised of an array/web/mesh of strand-like elements or filaments (see Altadonna para. 0040, absorbent fabric). Thus 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 Davi device’s delivery material to include strand-like elements or filaments, as taught by Altadonna (i.e. framework of 91 of Davi and pads 98a membranes 98 now being of material having strand-like elements or filaments), as this is a well-known type of agent delivery material for containing/delivering agent and would have been obvious substitution of one known element/type of material for another and one would expect the modified Davi device to perform equally as well.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davi in view of Hebrank et al. (2020/0289770).
Regarding claim 28, Davi discloses an agent delivery system (see Fig. 18-25, abstract for example) including the agent delivery device for delivering the agent to the individual according to claim 1 (see above discussion regarding claim 1), but is silent as to including a software application supporting use of the agent delivery device by the individual. However, Hebrank discloses an agent delivery device coupled with a software application supporting use of the agent delivery device by the individual (see Hebrank para. 0089 and 0128). Thus 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 Davi system to include a software application supporting use of the device, as taught by Hebrank, in order to facilitate patient training on use of the device (see Hebrank para. 0128).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Ede et al. (2015/0196420), Brown (2011/0118775), Brown (7,055,523), Brennan (5,931,852), and Petruson (RE 35,408) disclose intranasal agent delivery devices similar to the claimed/disclosed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
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