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 without traverse of Group I in the reply filed on 06/15/2026 is acknowledged.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/15/2026.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) and/or PCT Rule 11 are required in this application because they fail to comply with the following PCT Rule 11 sections.
New corrected drawings in compliance with PCT Rule 11.2 are required in this application because the granularity and light nature of the lines prevent reasonable reproduction of the drawings.
New corrected drawings in compliance with PCT Rule 11(a) are required in this application because the line and text quality, in each of the figures, makes it difficult to determine the structure of the claimed invention, since the lines are not “executed in durable, black, sufficiently dense and dark, uniformly thick and well-defined, lines and strokes without colorings.”
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Objections
Claims 7 & 14 are objected to because of the following informalities.
Claim 7 should read --The device according to claim 6, wherein the container is configured to contain 50 ml of the liquid solution.—
Claim 14 should read --The device according to claim 12, wherein the two expandable portions of the nostril plugs component comprise a network of internal tubes that allow the expandable portions to swell with the air coming from the air system and create an airtight lock with a user's nostrils.--
Appropriate correction is required.
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. Limitations which use the word means are also described below for clarification purposes. Such claim limitation(s) is/are as follows,
“a valve cover sealing means” in Claim 2, where the generic placeholder is “means”, the functional language is “valve cover sealing”, and sufficient modifying structure is not provided; the specification does not provide any additional structure; instant application Figure 3 shows a valve cover sealing means 25, but the figure is of such low quality, it is not possible to determine the structure from the figure; as such, the original disclosure does not provide sufficient modifying structure for the valve cover sealing means
“a valve plunger sealing means” in Claim 2, where the generic placeholder is “means”, the functional language is “valve plunger sealing”, and sufficient modifying structure is not provided; the specification does not provide any additional structure; instant application Figure 3 shows a valve plunger sealing means 26, but the figure is of such low quality, it is not possible to determine the structure from the figure; as such, the original disclosure does not provide sufficient modifying structure for the valve plunger sealing means
“a first spring means” in Claim 2, where the generic placeholder is “means”, the functional language is “spring”, and sufficient modifying structure is not provided; the specification does not provide any additional structure; instant application Figure 3 shows a first spring means 27, but the figure is of such low quality, it is not possible to determine the structure from the figure; as such, the original disclosure does not provide sufficient modifying structure for the first spring means
“actuator sealing means” in Claim 2, where the generic placeholder is “means”, the functional language is “actuator sealing”, and sufficient modifying structure is not provided; the specification does not provide any additional structure; instant application Page 7 defines the actuator sealing means as an O-ring, providing sufficient modifying structure
“a second spring means” in Claim 2, where the generic placeholder is “means”, the functional language is “spring”, and sufficient modifying structure is not provided; the specification does not provide any additional structure; instant application Figure 3 shows a second spring means 30, as a coil spring, providing sufficient modifying structure
“a spring means” in Claim 3, where the generic placeholder is “means”, the functional language is “spring”, and sufficient modifying structure is not provided; the specification does not provide any additional structure; instant application Figure 4 shows spring means 11, as a coil spring, providing sufficient modifying structure
“sealing means” in Claim 3, Lines 5-6, where the generic placeholder is “means”, the functional language is “sealing”, and sufficient modifying structure is not provided; the specification does not provide any additional structure; instant application Figure 4 shows sealing means 13, as an O-ring, providing sufficient modifying structure
“sealing means” in Claim 3, Lines 7-8, where the generic placeholder is “means”, the functional language is “sealing”, and sufficient modifying structure is not provided; the original disclosure does not provide sufficient modifying structure for the sealing means
“snap-fit mechanism” in Claims 5 & 16, where the generic placeholder is “mechanism”, the functional language is “snap-fit”, and sufficient modifying structure is not provided; the specification does not provide any additional structure; instant application Figure 12 shows a snap-fit mechanism 48, but the figure is of such low quality, it is not possible to determine the structure from the figure; as such, the original disclosure does not provide sufficient modifying structure for the snap-fit mechanism
“pump connection mechanism” in Claims 6 & 17, where the generic placeholder is “mechanism”, the functional language is “pump connection”, and sufficient modifying structure is not provided; the original disclosure does not provide sufficient modifying structure for the sealing means
“safety mechanism” in Claim 8, where the generic placeholder is “mechanism”, the functional language is “to protect the connection area of the cartridge from dirt and to certify that the cartridge has not been used before”, and sufficient modifying structure is not provided; the original disclosure does not provide sufficient modifying structure for the sealing means
“means of a snap-fit technology” in Claims 11 & 20, where the generic placeholder is “means”, the functional language is “snap-fit technology” to hold “all the nostril plugs assembly components together” and “creates mechanical tightening to create an airtight chamber inside”, and sufficient modifying structure is not provided; the original disclosure does not provide sufficient modifying structure for the means of a snap-fit technology
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.
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 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 1-14 & 16-20 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.
As to Claim 1, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims an air system for injecting air to a nostril plugs assembly. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain how the claimed air system is capable of injecting air –or even supplying air-- into any portion of the claimed invention.
The air system 2 is shown in instant application Figure 3, and described on Page 7, where the air system is described as being actuated by user pressure on actuator 28, to open valve 24, allowing air to pass through valve 24. However, there is no indication within the original disclosure describing how a pressure differential is created which would force air past valve 24 once actuator 28 is activated. The air bulb containing compressed air was entertained. However, instant application Page 2 teaches away from using compressed air, since “the use of such a device would either cause the user to choke and/or to feel highly uncomfortable, stressed, while injury could be provoked to upper respiratory system including ears via eustcahian tubes.” As such, the original disclosure does not provide a means for creating injected air, failing to provide sufficient written description for the limitation.
As to Claim 2, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a valve cover sealing means. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain the structure of the valve cover sealing means.
The instant application specification does not provide any additional structure. Instant application Figure 3 shows a valve cover sealing means 25, but the figure is of such low quality, it is not possible to determine the structure from the figure. As such, the original disclosure does not provide sufficient modifying structure for the valve cover sealing means, so does not provide sufficient written description for the valve cover sealing means.
Applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a valve plunger sealing means. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain the structure of the valve plunger sealing means.
The instant application specification does not provide any additional structure. Instant application Figure 3 shows a valve plunger sealing means 26, but the figure is of such low quality, it is not possible to determine the structure from the figure. As such, the original disclosure does not provide sufficient modifying structure for the valve plunger sealing means, so does not provide sufficient written description for the valve plunger sealing means.
Applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a first spring means. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain the structure of the first spring means.
The instant application specification does not provide any additional structure. Instant application Figure 3 shows a first spring means 27, but the figure is of such low quality, it is not possible to determine the structure from the figure. As such, the original disclosure does not provide sufficient modifying structure for the first spring means, so does not provide sufficient written description for the first spring means.
As to Claim 3, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims sealing means, in Lines 7-8. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain the structure of the sealing means.
The original disclosure does not provide any additional structure, so does not provide sufficient written description for the valve cover sealing means.
As to Claim 5, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims snap-fit mechanism. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain the structure of the snap-fit mechanism.
The instant application specification does not provide any additional structure. Instant application Figure 12 shows snap-fit mechanism 48, but the figure is of such low quality, it is not possible to determine the structure from the figure. As such, the original disclosure does not provide sufficient modifying structure for the snap-fit mechanism, so does not provide sufficient written description for the snap-fit mechanism.
As to Claim 6, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims pump connection mechanism. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain the structure of the pump connection mechanism.
The original disclosure does not provide any additional structure, so does not provide sufficient written description for the pump connection mechanism.
As to Claim 8, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims safety mechanism. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain the structure of the safety mechanism.
The original disclosure does not provide any additional structure, so does not provide sufficient written description for the safety mechanism.
As to Claim 11, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a support that holds all the nostril plugs assembly components together by means of a snap-fit technology or ultrasonic bonding and creates mechanical tightening to create an airtight chamber inside. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain the structure of the means of a snap-fit technology, or how the means of a snap-fit technology is capable of creating an airtight chamber as claimed.
The original disclosure does not provide any additional structure, so does not provide sufficient written description for the means of a snap-fit technology.
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 1-14 & 16-20 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.
As to Claim 1, the limitation “an air system for injecting air to a nostril plugs assembly”, in Line 5, is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear how the claimed air system is capable of injecting air, rendering the limitation indefinite.
The term “a nostril plugs assembly”, in Line 15, is indefinite. A nostril plugs assembly was defined in Line 5. As such, it is not clear if the assembly in Line 15 is the same assembly in Line 5, or if the respective assemblies are different. For the purpose of examination, the assembly in Line 15 will be interpreted as the assembly of Line 5.
As to Claim 2, the term “valve cover sealing means”, in Line 8, is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear what structure defines the valve cover sealing means, rendering the limitation indefinite.
The term “valve plunger sealing means”, in Line 9, is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear what structure defines the valve plunger sealing means, rendering the limitation indefinite.
The term “first spring means”, in Line 10, is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear what structure defines the first spring means, rendering the limitation indefinite.
The term “the user’s pressure”, in Line 13, lacks antecedent basis.
The term “the resilient tube”, in Line 16, is indefinite. Two resilient tubes were previously defined in Claim 1, Line 7, and Claim 1, Line 12. As such, it is not clear which resilient tube is being referred to in Claim 2, rendering the claim indefinite. For the purpose of examination, the resilient tube of Claim 2 will be interpreted as the resilient tube of Claim 1, Line 7.
As to Claim 3, the phrase “the outside of the cylinder”, in Line 4, lacks antecedent basis.
The term “sealing means” in Lines 7-8, is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear what structure defines the sealing means, rendering the limitation indefinite. Additionally, it is not clear if the sealing means in Lines 7-8, is the same sealing means as in Lines 5-6, or if the respective sealing means are different. For the purpose of examination, the respective sealing means will be interpreted as different sealing means.
As to Claims 5 & 16, the term “snap-fit mechanism” is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear what structure defines the snap-fit mechanism, rendering the limitation indefinite.
As to Claims 6 & 17, the term “pump connection mechanism” is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear what structure defines the pump connection mechanism, rendering the limitation indefinite.
As to Claim 8, the term “safety mechanism” is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear what structure defines the safety mechanism, rendering the limitation indefinite.
The term “the connection area” lacks antecedent basis.
The limitation “to certify that the cartridge has not been used before”, is indefinite. Since it is not clear what defines the safety mechanism, as described above, it also is not clear how the cartridge has not been used before may be certified. Additionally, the instant application has not provided a standard for determining the claimed certification.
As to Claims 10 & 19, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “a notch” is used by the claim to mean “a protrusion”, while the accepted meaning is “an indentation or incision on an edge or surface”. The term is indefinite because the specification does not clearly redefine the term. Instant application Figure 9 shows notch 46 as a protrusion, not an indentation or incision on an edge or surface.
The term “the plug system”, in Line 5, is indefinite. The term lacks antecedent basis. Additionally, it is not clear if the term may be referring to either the previously defined “plug-in system” or the “nostril plugs system”. For the purpose of examination, the term will be interpreted as the plug-in system.
As to Claims 11 & 20, the limitation “a support that holds all the nostril plugs assembly components together by means of a snap-fit technology or ultrasonic bonding and creates mechanical tightening to create an airtight chamber inside”, in Lines 8-10, is indefinite. It is not clear what structure or components are defined by the phrase “all the nostril plugs assembly components”. For example, the phrase may only include claimed components, or the phrase may include unclaimed/undisclosed components. If the phrase includes unclaimed/undisclosed components, it is not clear which components are included or not included.
Additionally, the term “safety mechanism” is indefinite. As described above, the limitation does not have sufficient written support. As such, it is not clear what structure defines the safety mechanism, or how the safety mechanism is capable of creating the claimed airtight chamber in the manner claimed, rendering the limitation indefinite.
As to Claim 13, the limitation “the two bell-shaped expandable portions are arranged at an angle (α) to offer perfect adaptation and ergonomics to the human nose and offer comfort and safety in the nasal cavity” is indefinite. It is not clear how to determine what is considered “perfect adaptation and ergonomics to the human nose”. One of ordinary skill in the art would conclude a “perfect” adaptation is dependent upon the anatomical design of a particular nose, and noses come in a large variety of anatomical designs. As such, a perfect adaptation for one nose may not be a perfect adaptation for another nose. The original disclosure has not provided a standard for the phrase “perfect adaptation and ergonomics to the human nose”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 13 recites the broad recitation “the angle α being between 130 degrees and 140 degrees”, and the claim also recites “most preferably 135 degrees” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Additionally, the phrase " most 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Drinan (2003/0145849 – see Figures 5/6) teaches a similar device as claimed, but does not teach the tubes are resilient. Naoum (2017/0340869 – see Figure 1a) teaches a similar device as claimed, but does not teach a plug-in system connected to the proximal end of the two-line resilient tube.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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