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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/15/2026 has been entered.
Response to Amendment
The amendment filed 01/15/2026 has been entered. Claim 1 has been amended. Claim 11 is indicated as new but was previously presented before. Claims 1-11 remain pending in this application.
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered but they are not persuasive.
Regarding claims 1-10 rejected under 35 USC §112, applicant has not provided amendments and/or arguments to overcome such rejection. The §112 rejection is therefore maintained.
Regarding claims 1 and 8, applicant’s arguments are with respect to a rejection under §102 or, in the alternative, § 103. However, such rejection was not relied upon in the Final Rejection mailed 10/01/2025. Applicant argues that Syk does not disclose a first outer surface and a second outer surface are substantially flat. However, as discussed below, Hsu teaches a first outer surface and a second outer surface that are substantially flat. Further, as discussed below, Syk makes obvious a hollow that defines a rectangular volume in the expanded state.
Regarding claim 3-7, 9-10, as discussed in the arguments above, Syk in view of Hsu teach the limitations of amended claim 1.
Regarding claim 11, the rejection does not rely on DuBois, but rather relies in Syk in view of Shippert.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, ln. 7 should read ---wherein the pad [[having the shape]] in the pressed state includes---
Appropriate correction is required.
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 1-10 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.
Claim 1 recites “wherein the pad having the pressed shape includes a first edge surface and a second edge surface which are opposite to each other in the first direction, and the first outer surface and a second outer surface which are opposite to each other in the second direction, are perpendicular to the second each other, and are substantially flat”. It is unclear which element of claim 1 is ‘perpendicular to the second direction’. It is unclear which elements are required to be substantially flat; the first edge and second edge, the first outer surface and the second outer surface, or both.
Claims 2-10 are rejected due to dependency on claim 1.
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.
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) 1-2 and 8 are rejected under 35 U.S.C. 103 as obvious over Syk (Pub. No.: US 2012/0046607 A1) in view of Hsu (Pub. No.: US 2016/0235953 A1).
Regarding claim 1, Syk discloses (fig. 2-3, annotated fig. 2b) a nasal cavity packing structure (plug 1) comprising:
A pad extending along a first direction (fig. 2a), having a shape pressed in a second direction perpendicular to the first direction (fig. 2b), and including first hollow extending along the first direction inside the pad (¶ 0040), the pad having a pressed state (fig. 2b) and an expanded state (fig. 2a) (¶ 0033, ¶ 0041); and
A tube (2, ¶ 0022), wherein an outer circumferential surface of the tube is closely adhered to an inner circumferential surface of the pad (fig. 2, ¶ 0022),
Wherein the pad having the shape pressed includes a first edge surface and a second edge surface which are opposite each other in the first direction (annotated fig. 2b), and a first outer surface and a second outer surface which are opposite to each other in the second direction (annotated fig. 2b), wherein the first direction is perpendicular to the second direction (annotated fig. 2b), wherein the first edge surface and the second edge surface are substantially flat in the pressed state (annotated fig. 2b), and
Wherein the first hollow extends from the first edge surface to the second edge surface (annotated fig. 2b).
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Syk annotated fig. 2b
Syk fails to explicitly disclose that the tube is an elastic tube. However, Syk discloses that the nasal cavity packing structure is compressed for easier insertion in the nasal cavity (¶ 0041) and that following insertion, the nasal cavity packing structure expands against the nasal passage to actively help stanch the blood flow (¶ 0024). Thus, the feature of the tube being elastic is inherent to the plug of Syk.
In the alternative, 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 tube of Syk such that it is elastic in order to allow the nasal cavity packing structure to be compressed for easier insertion in the nasal cavity (¶ 0041) and expand against the nasal passage to actively help stanch the blood flow (¶ 0024).
Syk fails to explicitly disclose that the first hollow defines a rectangular volume in the expanded state.
However, changes in shape are a matter of design choice which a person of ordinary skill in the art would have found obvious (In re Dailey, 149 USPQ 47, see MPEP § 2144.04 IV. B.) as the applicant has not demonstrated the criticality of this limitation. Applicant illustrates various shapes for the first hollow in the expanded state, such as oval and rectangular, that are suitable for allowing breathing through the nasal cavity (fig. 3-4, fig. 11-12).
Accordingly, 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 first hollow of Syk such that it defines a rectangular volume in the expanded state, in order to configure the first hollow to allow for air flow.
Syk fails to disclose that the first outer surface and the second outer surface are substantially flat.
Hsu teaches (fig. 1) a nasal cavity packing structure (abstract) and thus in the same field of endeavor, comprising: a pad (inflatable pillar 12), wherein the pad includes a first outer surface and a second outer surface which are opposite to each other in a second direction and are substantially flat (fig. 1).
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 first outer surface and the second outer surface of Syk such that they are substantially flat, as taught by Hsu, as such shape insertion into the nasal cavity (Hsu ¶ 0041).
Accordingly, changes in shape are a matter of design choice which a person of ordinary skill in the art would have found obvious (In re Dailey, 149 USPQ 47, see MPEP § 2144.04 IV. B.) as the applicant has not demonstrated the criticality of this limitation.
Regarding claim 2, Syk in view of Hsu fail to disclose wherein the elastic tube has a state in which first and second portions of the inner circumferential surface facing each other are closely adhered to and contact each other.
However, Syk discloses that the nasal cavity packing structure is compressed for easier insertion in the nasal passage (¶ 0041).
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 elastic tube of Syk in view of Hsu such that it has a state in which first and second portions of the inner circumferential surface facing each other are closely adhered to and contact each other, in order to allow the nasal cavity packing structure to fit into the nasal passage of a patient that is a child.
Regarding claim 8, Syk discloses wherein the pad comprises a super-absorbent (¶ 0022). Accordingly, the feature of “the pad has a characteristic of absorbing liquid to expand in volume” is inherent to the pad of Syk.
It is further noted: “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985)”.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Syk in view of Hsu, as applied to claim 1 above, and further in view of Bruce (Pub. No.: US 2015/0209191 A1)
Regarding claim 3, Syk in view of Hsu fail to disclose a coating film is formed on an inner circumferential surface of the elastic tube; and a viscosity of the coating film is smaller than a viscosity of the elastic tube.
Bruce teaches (fig. 2) a nasal cavity packing structure (dressing 16,abstract) comprising a pad (¶ 0007) and a tube (capsule 18), wherein a coating film is formed on an inner circumferential surface of the tube (the capsule contains a solution ¶ 0025); and a viscosity of the coating film is smaller than a viscosity of the tube (coating is a solution ¶ 0025 and thus flowable).
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 elastic tube of Syk in view of Hsu such that a coating film is formed on an inner circumferential surface of the elastic tube; and a viscosity of the coating film is smaller than a viscosity of the elastic tube, as taught by Bruce, in order to allow a solution to be delivered to the user that constricts blood vessels and stops the flow of blood (Bruce ¶ 0025).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Syk in view of Hsu, as applied to claim 1 above, and further in view of Jenkins, JR. et al. (Pub. No.: US 2005/0056289 A1), hereinafter Jenkins.
Regarding claim 4, Syk in view of Hsu fail to disclose the elastic tube comprises a plurality of protrusions protruding from its outer circumferential surface, and the pad comprises a groove or a through hole into which the protrusion is inserted.
Jenkins teaches (fig. 17-17A) a packing structure (250) and thus in the same field of endeavor, comprising a pad (resilient foam body 262); and an elastic tube (stiffener 251, stiffener can be constructed of elastomeric material ¶ 0030, stiffener may be a tube ¶ 0034), wherein the elastic tube comprises a plurality of protrusions (flanges 252, 254, 256) protruding outward from its outer circumferential surface (¶ 0040, fig. 17A-17), and the pad comprises a groove or through hole into which the protrusion is inserted (fig. 17, ¶ 0040).
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 elastic tube and pad of Syk in view of Hsu such that they comprise a plurality of protrusions protruding from its outer circumferential surface a groove or a through hole into which the protrusion is inserted, respectively, as taught by Jenkins, in order to provide a secure connection between the elastic tube and the pad.
Regarding claim 5, Syk in view of Hsu fail to disclose wherein the elastic tube comprises a plurality of concave grooves recessed inward from its outer circumferential surface or a plurality of through holes penetrating therethrough; and the pad comprises a protrusion inserted into the concave groove or through hole.
Jenkins teaches (fig. 17-17A) a packing structure (250) and thus in the same field of endeavor, comprising a pad (resilient foam body 262); and an elastic tube (stiffener 251, stiffener can be constructed of elastomeric material ¶ 0030, stiffener may be a tube ¶ 0034), wherein the elastic tube comprises a plurality of concave grooves recessed inward from an outer circumferential surface or a plurality of through holes penetrating therethrough (see concave grooves formed in between flanges 2582, 254, 256); and the pad comprises protrusions inserted into the concave groove or through hole (fig. 17, ¶ 0040).
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 elastic tube and pad of Syk in view of Hsu such that they comprise a plurality of concave grooves recessed inward from its outer circumferential surface or a plurality of through holes penetrating therethrough and a protrusion inserted into the concave groove or through hole, respectively, as taught by Jenkins, in order to provide a secure connection between the elastic tube and the pad.
Claims 6-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Syk in view of Hsu, as applied to claim 1 above, and further in view of DeBois (Pub. No.: US 2019/0029880 A1)
Regarding claim 6, Syk in view of Hsu fail to disclose an auxiliary pad filling a second hollow inside the elastic tube.
DuBois teaches (fig. 1) a nasal cavity packing structure (nasal insert 6, ¶ 0002) comprising a pad (cover 19) and an auxiliary pad (core 11) filling a hollow (fig. 1, ¶ 0035).
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 elastic tube of Syk in view of Hsu such that it comprises the auxiliary pad of DuBois filling a second hollow inside the elastic tube, in order to allow for the pad to be wetted to reduce friction during insertion (DuBois ¶ 0035) and the auxiliary pad to absorb blood and apply light pressure to the source of the bleeding (DuBois ¶ 0024).
Regarding claim 7, Syk in view of Hsu and further in view of DuBois disclose wherein the auxiliary pad comprises a material identical to or different from that of the pad (the auxiliary pad comprises polyethylene, Dubois ¶ 0033 and the pad comprises superabsorbent type fluff pulp Syk ¶ 0022).
Regarding claim 9, Syk in view of Hsu and further in view of Dubois disclose wherein the auxiliary pad comprises polyethylene (Dubois ¶ 0033) and the pad comprises superabsorbent type fluff pulp (Syk ¶ 0022). Thus, Syk in view of Dubois disclose wherein the pad and the auxiliary pad have a characteristic of absorbing liquid to expand in volume and an expansion rate of the auxiliary pad is equal to or different from an expansion rate of the pad.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Syk in view of Hsu, as applied to claim 1 above, and further in view of Shippert (Pat. No.: US 6,191,341 B1)
Regarding claim 10, Syk in view of Hsu fail to disclose the pad comprises polyvinyl alcohol, polyvinyl acetate, or polyurethane.
Shippert teaches (fig. 1) a nasal cavity packing structure (absorbent pack 20, col. 5, ln. 21-26) and thus in the same field of endeavor, comprising a pad (24), wherein the pad comprises polyvinyl alcohol, polyvinyl acetate (col. 5, ln. 36-39), or polyurethane.
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 pad of Syk such that it comprises polyvinyl alcohol, polyvinyl acetate, or polyurethane, as taught by Shippert as such material is well-known and widely utilized for absorbing liquids including blood (Shippert col. 5, ln. 36-39).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Syk in view of Shippert.
Regarding claim 11, Syk discloses (fig. 2-3) a nasal cavity packing structure (plug 1) comprising:
A pad extending along a first direction (fig. 2a), having a shape pressed in a second direction perpendicular to the first direction (fig. 2b), and including first hollow extending along the first direction inside the pad (¶ 0040);
A tube (2, ¶ 0022), wherein an outer circumferential surface of the tube is closely adhered to an inner circumferential surface of the pad (fig. 2, ¶ 0022).
Syk fails to explicitly disclose that the tube is an elastic tube. However, Syk discloses that the nasal cavity packing structure is compressed for easier insertion in the nasal cavity (¶ 0041) and that following insertion, the nasal cavity packing structure expands against the nasal passage to actively help stanch the blood flow (¶ 0024). Thus, the feature of the tube being elastic is inherent to the plug of Syk.
In the alternative, 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 tube of Syk such that it is elastic in order to allow the nasal cavity packing structure to be compressed for easier insertion in the nasal cavity (¶ 0041) and expand against the nasal passage to actively help stanch the blood flow (¶ 0024).
Syk fails to disclose an auxiliary pad filling a second hollow inside the elastic tube, wherein the auxiliary pad has no hollow therein.
Shippert teaches (fig. 1) a nasal cavity packing structure (absorbent pack 20): comprising a pad (enclosure member 60) including a hollow (fig. 1);
An auxiliary pad (absorbent member 24) filling the hollow (fig. 1, col. 5, ln. 66-col. 7, ln. 1),
Wherein the auxiliary pad has no hollow therein (fig. 1).
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 nasal cavity packing structure of Syk such that it comprises the auxiliary pad having no hollow therein of Shippert, filling a second hollow inside the elastic tube, in order to provide a pad that avoids adherence to the body area (Shippert col. 6, ln. 5-7) and an auxiliary pad that can absorb liquid (Shippert col. 5, ln. 36-45).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fischell (Pub. No.: US 2018/0289383 A1) discloses a nasal cavity packing structure having a first hollow. Song (Pub. No.: US 2013/0116656 A1) discloses a nasal cavity packing structure having a first hollow.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781