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 .
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(a-d) with reference to Application Number: GB2202890.6 filed on 03/02/2022.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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 XXX 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.
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, claims 2 – 6 and 23 recite a broad recitation, and the claims also recite “preferably” which is the narrower statement of the range/limitation. It is unclear whether the limitations following the phrase “preferably” are part of the claimed invention. See MPEP § 2173.05(d). For example, claim 2 recites a maximum flare angle that is 35 to 65 degrees, but also recites that the maximum flare angle is preferably 58 degrees. 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.
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)(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, 3 – 7, 10 – 11, 13, and 15 - 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamishita (US 20220249787).
1. A nasal piece comprising a body (see Fig. 4, 10) having a tip for insertion into a range of sizes of nostril (11a, the tip is as low as 3 mm and thereby fully capable of fitting into a range of nostril sizes, see [0090]), the body comprising: a first flared section that widens in a longitudinal direction away from the tip (see Fig. 4 and attachment 1 below, “1FS”); a second flared section that also widens in the longitudinal direction away from the tip (see attachment 2 below, “2FS”); the first flared section being more proximate to the tip than the second flared section (see Fig. 4 and attachment 4 below); the first flared section defining a first abutment zone for engaging in a first nostril having a first range of sizes (the flared section defines a diameter D2 such as 4.5mm (0.18 in.) or 7.6mm (0.3 in.), see [0088], thereby being fully capable of engaging pediatric nostril sizes at or lower than the range; see evidencing reference to Denton (US 20130298902), [0048], [0051], disclosing that pediatric nostril sizes range from 0.3 in. and below); the second flared section defining a second abutment zone for engaging in a second nostril having a second range of sizes (see [0107 – 0108], whereby noses are variable in size and the second flared section would be fully capable of abutting a range of adult sizes); wherein the first abutment zone has a maximum flare angle that is greater than a maximum flare angle of the second abutment zone (see attachment 2 below).
Attachment 1
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Attachment 2
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3. Kamishita discloses a nasal piece as claimed in claim 1, wherein a flare angle of the first abutment zone is constant along a longitudinal length of the first abutment zone (see Fig. 4, as well as [0110] disclosing reducing the tip in a linear or stepwise manner); and optionally wherein the flare angle of the first abutment zone is 35° to 65°, preferably 40° to 60°, more preferably 58°.
4. Kamishita discloses a nasal piece as claimed in claim 1, wherein a flare angle of the first abutment zone varies along a longitudinal length of the first abutment zone (the reduction can be of mixed manner such as linear and curved, see [0110] in Kamishita); and optionally wherein the flare angle varies from a minimum flare angle of 15° to 20° to the maximum flare angle of 35° to 65°, preferably 40° to 60°, more preferably 58°
5. Kamishita discloses a nasal piece as claimed in claim 1, wherein a flare angle of the second abutment zone is constant along a longitudinal length of the second abutment zone (see Fig. 4, as well as [0110] disclosing reducing the rest in a linear or stepwise manner); and optionally wherein the flare angle of the second abutment zone is 10° to 30°, preferably 15° to 25°, more preferably 18°.
6. Kamishita discloses a nasal piece as claimed in claim 1, wherein a flare angle of the second abutment zone varies along a longitudinal length of the second abutment zone (the reduction can be a mix of linear and curved, see [0110] in Kamishita); and optionally wherein the flare angle varies from a minimum flare angle of 5° to 10° to the maximum flare angle of 10° to 30°, preferably 15° to 25°, more preferably 18°.
7. Kamishita discloses a nasal piece as claimed in claim 1, wherein a longitudinal length of the first abutment zone and/or the first flared section is shorter than a longitudinal length of the second abutment zone and/or the second flared section (see attachment 3 below).
Attachment 3:
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10. Kamishita discloses a nasal piece as claimed in claim 1, wherein the second flared section is wider than the first flared section (see Fig. 4).
11. Kamishita discloses a nasal piece as claimed in claim 1, wherein an external diameter of the first abutment zone at its end nearest the tip has a diameter of 6.60 to 7.50 mm, optionally of 6.90 to 7.20 mm, optionally of 7.09 mm (see Fig. 4, [0090], [0110], portion 11 is reduced in a stepwise manner and the face of the nozzle exit point, which has the same diameter as the first abutment zone at its end nearest the tip, has a diameter between 3.5 and 8.5mm); and/or an external diameter of the first abutment zone at its end furthest from the tip has a diameter of 9.50 to 11.00 mm, optionally of 9.75 to 10.50 mm, optionally of 10.43 mm.
13. Kamishita discloses a nasal piece as claimed in claim 1, wherein the body comprises a shoulder or convex section that separates at least a portion of the first abutment zone from at least a portion of the second abutment zone (see attachment 1 above, portion between 1FS and 2FS).
15. Kamishita discloses a nasal piece as claimed in claim 1, wherein the first flared section comprises a frusto-conical and/or a concave section and/or a convex section and/or the second section comprises a frusto-conical and/or concave section and/or a convex section (see Fig. 4).
16. Kamishita discloses a nasal piece as claimed in claim 1, wherein a longitudinal axis of the first flared section is coincident with a longitudinal axis of the second flared section (see Figs. 4b, 5c).
17. Kamishita discloses a nasal piece as claimed in claim 1, wherein the body further comprises a tip section that comprises the tip of the body and extends from the tip to the first flared section, optionally wherein the tip section is convex (see Fig. 4, portion between 1FS and nozzle exit point).
18. Kamishita discloses a nasal piece as claimed in claim 1, wherein the body further comprises one or more shoulders for engagement by one or more fingers, the one or more shoulders being located further from the tip than the second flared section (13 and/or 13’, see [0111]; examiner additionally notes that protruding aspect of 12 directly under the label 12 in Fig. 4a may be considered fully capable of engagement by a finger(s)).
19. Kamishita discloses a nasal spray, nasal cannula, nebulizer or nasal dilator comprising a nasal piece as claimed in claim 1 (see Fig. 28, Fig. 31, [0179]).
Claim Rejections - 35 USC § 102/103
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 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)(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.
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.
Claim(s) 20 - 23 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Kamishita or, in the alternative, under 35 U.S.C. 103 as obvious over Kamishita in view of Denton (US 20130298902).
20. Kamishita discloses a method of using the nasal piece as claimed in claim 1, comprising, in a first mode of use, inserting the nasal piece into a first nostril having a first range of sizes such that the first nostril is abutted against the first abutment zone of the first flared section (the first flared section defines a diameter D2 such as 4.5mm (0.18 in.) or 7.6mm (0.3 in.), see [0088], thereby being fully capable of engaging pediatric nostril sizes at or lower than the range; see evidencing reference to Denton (US 20130298902), [0048], [0051], disclosing that pediatric nostril sizes range from 0.3 in. and below); and, in a second mode of use, inserting the nasal piece into a second nostril having a second range of sizes such that the second nostril is abutted against the second abutment zone of the second flared section (see [0107 – 0108], whereby noses are variable in size and the second flared section would be fully capable of abutting a range of adult sizes). (Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device; it is submitted that inserting the nasal piece into the nares of any user is normal and usual operation.)
However, without admitting otherwise, it would have been obvious to one of ordinary skill in the art to use the nasal piece of claim 1 by, in a first mode of use, inserting the nasal piece into a first nostril having a first range of sizes such that the first nostril is abutted against the first abutment zone of the first flared section; and, in a second mode of use, inserting the nasal piece into a second nostril having a second range of sizes such that the second nostril is abutted against the second abutment zone of the second flared section. Denton discloses in a first mode of use, inserting a nasal piece into a first nostril having a first range of sizes such that the first nostril is abutted against a first abutment zone; and, in a second mode of use, inserting the nasal piece into a second nostril having a second range of sizes such that the second nostril is abutted against a second abutment zone (see Fig. 5, [0048 – 0051], where it is understood that the abutting shield would have different abutment zones based on the nostril size of the child or adult). Examiner notes that sizes of the tip and first abutment zone of Kamishita corresponds to the tip and first abutment zone of Denton, see [0088] and [0048], respectively, as well as rejection in claim 1 above. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the first and second abutment zones of Kamishita with correspondingly sized child and adult patients as taught in Denton for the benefit of delivering the medicament spray to a large groups of users variable in size, for example to include child patients in need of the therapeutic spray sized to their anatomy.
21. Kamishita or alternatively Kamishita in view of Denton discloses use of a nasal piece as claimed in claim 20, wherein the first nostril is a nostril of a paediatric user and the second nostril is a nostril of an adult user (see claim 20 above).
22. Kamishita discloses a method of manufacturing the nasal piece as claimed in claim 1, comprising forming the body of the nasal piece to have the tip, the first flared section that widens in a longitudinal direction away from the tip and the second flared section that also widens in the longitudinal direction away from the tip, wherein the first flared section is more proximate to the tip than the second flared section, and the first flared section defines the first abutment zone for engaging in the first nostril having the first range of sizes, and the second flared section defines the second abutment zone for engaging in the second nostril having the second range of sizes, wherein the first abutment zone has a maximum flare angle that is greater than a maximum flare angle of the second abutment zone (see claim 1 above, [0080]).
23. Kamishita discloses the method of claim 22, wherein the nasal piece is formed as a single piece (see [0080]); and optionally formed by moulding, preferably injection moulding.
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.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamishita.
9. Kamishita discloses a nasal piece as claimed in claim 1, but does not explicitly disclose wherein the second abutment zone extends at least between locations that are 12.0 mm to 15.0 mm longitudinally from the tip; optionally at least between locations that are 12.0 mm to 20.0 mm longitudinally from the tip; optionally at least between locations that are 10.0 mm to 20.0 mm longitudinally from the tip. Nonetheless, Kamishita discloses that the length of the tip portion 11, at which the second abutment zone would begin, is between 10 mm or more and 15 mm or less, see [0093], Fig. 4a. Kamishita discloses that the length of the tip portion and second abutment zone results in optimized spray delivery/width to the target nasal region, see [0093], [0082]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the second abutment zone of Kamishita to extend at least between locations that are 12.0 mm to 15.0 mm longitudinally from the nasal tip for the benefit of optimized spray delivery/width to the target nasal region. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
12. Kamishita discloses a nasal piece as claimed in claim 1, but does not explicitly disclose wherein an external diameter of the second abutment zone at its end nearest the tip has a diameter of 10.50 to 11.50 mm, optionally of 10.70 to 11.00 mm, optionally of 10.70 to 10.90 mm, optionally of 10.85 mm or 10.96 mm; and/or an external diameter of the second abutment zone at its end furthest from the tip has a diameter of 11.00 to 20.00 mm, optionally 11.00 to 16.00 mm, optionally 11.00 to 15.00 mm, optionally of 11.75 to 15.00 mm, optionally of 14.00 to 15.00 mm, optionally of 11.75 mm or 14.75 mm. Nonetheless, Kamishita discloses that an external diameter D1 of nose ridge 12 has a diameter of 11.00 to 20.00 mm (see [0103]). The external diameter of the nose ridge roughly equates to that of the second abutment zone (see Fig. 4), both of which abut the user’s nares, which results in improvement of abutting performance with the nose while facilitating improved handling. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the external diameter of the second abutment zone of Kamishita for the benefit of improving abutting performance within the nose while facilitating improved handling. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Claim(s) 2, 8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamishita in view of Denton.
2. Kamishita discloses a nasal piece as claimed in claim 1, but does not explicitly disclose wherein the maximum flare angle of the first abutment zone is 35° to 65°, preferably 40° to 60°, more preferably 58° and/or the maximum flare angle of the second abutment zone is 10° to 30°, preferably 15° to 25°, more preferably 18°. Nonetheless, Denton discloses a second abutment zone having a maximum flare angle that is 10° to 30°, see [0049]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the second abutment zone of Kamishita according to the maximum flare angle of Denton for the benefit of preventing over-insertion while maintaining self-centering ability.
8. Kamishita discloses a nasal piece as claimed in claim 1, but does not disclose wherein the first abutment zone extends at least between locations that are 5.0 mm to 7.0 mm longitudinally from the tip. Kamishita does appear to reasonably illustrate the feature, see Fig. 4 and [0093]. Nonetheless, Denton discloses wherein a first abutment zone begins at 5.0 mm, see [0048], where the length of the first abutment zone results in sufficient protrusion of the tip into the nostril of the user while avoiding causing tissue damage inside a child’s nostril. Therefore, according to the teachings of Denton, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the first abutment zone of Kamishita to extend between locations that are 5.0 mm to 7.0 mm longitudinally from the tip as such feature is reasonably illustrated in Kamishita and would provide the benefit of sufficient protrusion of the tip into the nostril of the user, while avoiding causing tissue damage inside a child’s nostril.
14. Kamishita discloses a nasal piece as claimed in claim 13, wherein the shoulder or convex section of the body is located under 10 mm longitudinally from the tip, see [0093], Fig. 4a. However, Kamishita does not disclose that the shoulder or convex section of the body is located over 5 mm longitudinally from the tip. Nonetheless, Denton discloses that a first abutment zone begins at 5.0 mm longitudinally from the tip, see [0048], wherein the shoulder of Kamishita would therefore locate over 5 mm longitudinally from the tip. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the shoulder of Kamishita according to the relative tip placement of Denton for the benefit of sufficient protrusion of the tip into the nostril of the user, while avoiding causing tissue damage inside a child’s nostril.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US D994114 – apparent shape of the nozzle
US 20190001088 – apparent shape of the nozzle
US 20180133731 – nozzle with angles
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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