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 .
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:
Claim 1, ln 6, “functional substance accommodation member” and its dependents. The recitation of “functional substance accommodation member” in claims 8 and 11 does not invoke 112(f) since there is the added structure of “a stick” and “a capsule” in claim 8 and “a capsule” in claim 11.
Such structure is/are:
“a stick” and “a capsule”, see specification pg. 2 ln 7-10 and 17-18.
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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the first piercing member" and “the second piercing member” in ln 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggest amending claim 4 to depend on claim 2 or amending the claim to read "a" and “a second piercing member”.
Claim Rejections - 35 USC § 102
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) 1-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kwon et al. (US 20230191044 A1).
Regarding claim 1, Kwon discloses an inhaler for inhaling a functional substance ([0041] drug vaporization and inhalation device; figure 1-6, also see figure 7-8B), the inhaler comprising:
a first holder ([0041] body 40; figure 1-4 and 7-8B);
a second holder ([0041] cap 50; figure 1-2 and 5-7) rotatably connected to the first holder ([0069] The cap 50 is rotatably coupled to top of the body 40 and has a mixing space 51 formed on the inner bottom thereof to face the capsule accommodation portion 42 formed on top of the body 40; figure 1-2 and 7);
a piercing member protruding toward an internal space of the second holder ([0070] blades 53 protruding downward from the inner bottom thereof to partially incise the surface of the capsule 41 placed in the capsule accommodation portion 42; figure 1-2 and 5-7); and
a functional substance accommodation member (“as noted above this term invokes 112f”, see [0063], capsule accommodation portion 42 and capsule 41) disposed in the internal space of the second holder ([0069] The cap 50 is rotatably coupled to top of the body 40 and has a mixing space 51 formed on the inner bottom thereof to face the capsule accommodation portion 42 formed on top of the body 40; figure 2. “capsule accommodation portion 42 and capsule 41 are disposed in the internal space of the second holder, including the mixing space 51, as seen in figure 2) and configured to accommodate the functional substance ([0063] for accommodating a capsule 41 in which a powdered drug for an infected patient with asthma, a coronavirus, or the like is sealedly stored),
wherein at least a portion of the functional substance accommodation member is open by the piercing member according to a rotation of the second holder ([0071] When the cap 50 rotates, the blades 53 for the incision of the surface of the capsule 41 pass through the blade moving paths 42c formed in spaces between the plate-shaped first wall members 42a and the arch-shaped second wall members 42b disposed in the capsule accommodation portion 42 formed on top of the body 40 and thus incise one side of top of the capsule 41 placed in the capsule accommodation portion 42 to discharge the powdered drug from the capsule 41; figure 2-4 and 7-8B).
Regarding claim 2, Kwon discloses the inhaler of claim 1, wherein the piercing member comprises:
a first piercing member (see figure 1-2 and 5-7, one of the left blade 53 or the right blade 53); and
a second piercing member (see figure 1-2 and 5-7, the other of the left blade 53 or the right blade 53) disposed spaced apart from the first piercing member in a direction parallel to a rotation axis of the second holder (see figure 2, distance between blades 53 and rotational axis at arrow of inhalation pipe 52.).
Regarding claim 3, Kwon discloses the inhaler of claim 2, wherein the first piercing member and the second piercing member are disposed to face each other about the rotation axis of the second holder (see figure 5-6, flat sides of blades 53 facing each other in the direction of inhalation pipe).
Regarding claim 4, Kwon discloses the inhaler of claim 1, wherein a cutting edge of the first piercing member and a cutting edge of the second piercing member are directed toward a rotation axis of the second holder ([0071] When the cap 50 rotates, the blades 53 for the incision of the surface of the capsule 41 pass through the blade moving paths 42c formed in spaces between the plate-shaped first wall members 42a and the arch-shaped second wall members 42b disposed in the capsule accommodation portion 42 formed on top of the body 40 and thus incise one side of top of the capsule 41 placed in the capsule accommodation portion 42 to discharge the powdered drug from the capsule 41; figure 4. The tip of blades 53 are directed toward and move in a direction of the blade moving paths 42c, as depicted in figure 4, which is toward a central rotation axis of cap 50 since the cap 50 rotates causing the blades 53 to also rotate).
Regarding claim 5, Kwon discloses the inhaler of claim 1, wherein
the second holder is rotatable relative to the first holder between a first rotation position ([0084] In this case, if the infected patient with asthma, a coronavirus, or the like desires to inhale only the vaporized steam discharged to the second guide paths 43, he or she minimizes the rotation of the cap 50, while watching the first and second marks T1 and T2 formed on the outer peripheral surfaces of the body 40 and the cap 50. see figure 2 and [0084-0086], initial starting position of cap 50 and body 40 after initial coupling and before incision of capsule 41) and a second rotation position ([0087] However, if the infected patient with asthma, a coronavirus, or the like desires to mix the vaporized steam discharged to the second guide paths 43 with the powdered drug of the capsule 41 and to inhale the vaporized steam mixed with the powdered drug, he or she increases the rotation of the cap 50, while watching the first and second marks T1 and T2 formed on the outer peripheral surfaces of the body 40 and the cap 50. see figure 4 and [0087-0089]); and
a rotation angle of the second holder at the first rotation position (see figure 2 and [0084-0086], rotational angle at initial starting position of cap 50 and body 40 after initial coupling and before incision of capsule 41 is close to 0° while first and second marks T1 and T2 are aligned, see [0079-0080]) is less than a rotation angle of the second holder at the second rotation position ([0087] he or she increases the rotation of the cap 50, while watching the first and second marks T1 and T2 formed on the outer peripheral surfaces of the body 40 and the cap 50. [0088] That is, when the locking protrusions 54 of the cap 50 rotate along the rail grooves 44 after seating onto one side protrusion slots 45 of the body 40, the rotation of the cap 50 is increased to allow the locking protrusions 54 to pass through the blade moving paths 42c formed on the capsule accommodation portion 42 and to then seated onto the other side protrusion slots 45; see figure 7).
Regarding claim 6, Kwon discloses the inhaler of claim 5, wherein a rotation angle marker for indicating a rotation angle of the second holder is provided in one of the first holder or the second holder ([0079] Further, the body 40 has a first mark T1 formed on the outer peripheral surface thereof and the cap 50 has a second mark T2 formed on the outer peripheral surface that correspond to one side locking protrusion 54. [0080] The first and second marks T1 and T2 serve to guide a position where only the vaporized steam induced through the first guide path 12 is selectedly discharged through the inhalation pipe 52 or a position where the powdered drug discharged from the capsule 41 is mixedly contained in the vaporized steam and thus discharged, without any damage on the capsule 41 located inside the capsule accommodation portion 42, according to the rotating range of the cap 50; figure 5 and 7. Position of T2 relative to T1 indicates the rotation angle of the cap 50 relative to the starting position).
Regarding claim 7, Kwon discloses the inhaler of claim 1,wherein
an internal space of the first holder and the internal space of the second holder are configured in cylindrical shapes connected to each other ([0069] The cap 50 is rotatably coupled to top of the body 40 and has a mixing space 51 formed on the inner bottom thereof to face the capsule accommodation portion 42 formed on top of the body 40; figure 1-2 and 7), and
the functional substance accommodation member is configured to be insertable into the internal space of the first holder and the internal space of the second holder ([0065] The capsule accommodation portion 42 protruding from top of the body 40 includes a pair of plate-shaped first wall members 42a and 42a′ for supporting left and right walls of the capsule 41 and a pair of arch-shaped second wall members 42b and 42b′ facingly spaced apart from each other in different directions from the pair of first wall members 42a and 42a′ to support both ends of the capsule 41, so that a space for accommodating the capsule 41 is formed; figure 1-4. see figure 2, capsule accommodation portion 42 is configured as part of body 40 and forms part of the internal space of body 40 which is also coupled to mixing space 51 portion of internal space of cap 50).
Regarding claim 8, Kwon discloses the inhaler of claim 7, wherein the functional substance accommodation member comprises:
a stick configured to be insertable into the internal space of the first holder and the internal space of the second holder ([0065] The capsule accommodation portion 42 protruding from top of the body 40 includes a pair of plate-shaped first wall members 42a and 42a′ for supporting left and right walls of the capsule 41 and a pair of arch-shaped second wall members 42b and 42b′ facingly spaced apart from each other in different directions from the pair of first wall members 42a and 42a′ to support both ends of the capsule 41. see figure 2-3 and 7, capsule accommodation portion 42 is configured as part of body 40 and forms part of the internal space of body 40 which is also coupled to mixing space 51 portion of internal space of cap 50); and
a capsule disposed in an inside of the stick and configured to accommodate the functional substance ([0071] the capsule accommodation portion 42 formed on top of the body 40 and thus incise one side of top of the capsule 41 placed in the capsule accommodation portion 42 to discharge the powdered drug from the capsule 41; figure 3).
Regarding claim 9, Kwon discloses the inhaler of claim 8, wherein a diameter of the internal space of the second holder is formed to be greater than a diameter of the internal space of the first holder (see figure 2, diameter of mixing space 51 of cap 50 is greater than diameter of internal space of body 40 formed by capsule accommodation portion 42).
Regarding claim 10, Kwon discloses the inhaler of claim 2,wherein
the first piercing member and the second piercing member are configured to be movable between a first piercing position ([0084] In this case, if the infected patient with asthma, a coronavirus, or the like desires to inhale only the vaporized steam discharged to the second guide paths 43, he or she minimizes the rotation of the cap 50, while watching the first and second marks T1 and T2 formed on the outer peripheral surfaces of the body 40 and the cap 50. see figure 2 and [0084-0086], blades 53 at initial starting position of cap 50 and body 40 after initial coupling and before incision of capsule 41) and a second piercing position ([0088] That is, when the locking protrusions 54 of the cap 50 rotate along the rail grooves 44 after seating onto one side protrusion slots 45 of the body 40, the rotation of the cap 50 is increased to allow the locking protrusions 54 to pass through the blade moving paths 42c formed on the capsule accommodation portion 42 and to then seated onto the other side protrusion slots 45; see figure 4), and
the second piercing position is configured to protrude further toward the rotation axis of the second holder than the first piercing position (when the cap 50 is rotated to a second piercing position, blades 53 are directed toward and move in a direction of the blade moving paths 42c, as depicted in figure 4, which is further toward a central rotation axis of cap 50 since rotation of the cap 50 causes blades 53 to rotate).
Regarding claim 11, Kwon discloses the inhaler of claim 1, wherein the functional substance accommodation member comprises a capsule accommodating the functional substance ([0063] for accommodating a capsule 41 in which a powdered drug for an infected patient with asthma, a coronavirus, or the like is sealedly stored), and
a portion of the capsule is fixed to the first holder ([0072] the body 40 includes second guide paths 43 formed at the outside of the capsule accommodation portion 42 formed on top thereof to discharge the vaporized steam to the capsule 41 accommodatedly fixed to the plate-shaped first wall members 42a and the arch-shaped second wall members 42b; figure 2-4 and 7-8B) so that the capsule is rotatable relative to the second holder (see figure 1-2, body 40 is rotatably coupled to vaporization container 10 via threads shown on top portion of container 10, thus capsule 41 held in capsule accommodation portion 42 of body 40 is rotatable via coupling or decoupling of body 40 to/from vaporization container 10).
Regarding claim 12, Kwon discloses the inhaler of claim 11, wherein the piercing member is disposed in the second holder in a state of penetrating at least a portion of the capsule ([0071] When the cap 50 rotates, the blades 53 for the incision of the surface of the capsule 41 pass through the blade moving paths 42c formed in spaces between the plate-shaped first wall members 42a and the arch-shaped second wall members 42b disposed in the capsule accommodation portion 42 formed on top of the body 40 and thus incise one side of top of the capsule 41 placed in the capsule accommodation portion 42 to discharge the powdered drug from the capsule 41; figure 2-4 and 7-8B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Parsons (US 20120103332 A1) teaches a powder delivery device including a piercing device actuated via rotation.
Yama et al. (US 20060169280 A1) teaches an inhalation device with a piercing member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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