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 .
Response to Amendment
This office action is responsive to the amendment filed on June 12, 2023. As directed by the amendment: no claims have been amended, claims 1-11 have been canceled, and new claims 12-22 have been added. Thus, claims 12-22 are presently pending in the application.
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:
“means…to retain the tube with the patient’s neck” in claim 12 interpreted according to page 4 of the specification as a neck tie or sutures threaded through the skin.
“securing means” in claims 19, and 22, interpreted according to page 4 of the specification as a neck tie or sutures threaded through the skin.
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.
Claims 12-22 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 pre-AIA the applicant regards as the invention.
Claim 12 recites the limitations “the machine end” in line 1-2 and "the patient’s neck" in line 4. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 recites the limitation "can be" in lines 3-4, which renders the claim indefinite as it is not clear whether the securing means are part of the invention or are optional. Examiner suggests amending the language to read: --…and being provided with an opening towards each end, the opening configured to receive a securing means a
Claim 19 recites the limitation "can be" in lines 6-7, which renders the claim indefinite as it is not clear whether the securing means are part of the invention or are optional. Examiner suggests amending the language to read: --…provides an opening towards opposite ends of the flange, the opening configured to receive a securing means
Claim 22 recites the limitation "can be" in lines 6-7, which renders the claim indefinite as it is not clear whether the securing means are part of the invention or are optional. Examiner suggests amending the language to read: --…provides an opening towards opposite ends of the flange, the opening configured to receive a securing means
Claim 22 recites “A tube having a mounting flange manufactured by a method including the steps of:” which renders the claim indefinite as it is not clear whether it is a apparatus claim or a method claim. Examiner suggests amending to read -- A tube having a mounting flange manufactured by
Claims 13-18 and 20-21 are rejected based solely on their dependency to rejected claims.
Allowable Subject Matter
Claims 12-22 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Depel (US 2013/0255693) represents the closest prior art to the claimed invention.
As to claim 12, Depel discloses tracheostomy tube 10 (Fig. 1, Fig. 2) including a shaft (tracheal tube 14) and a mounting flange (neck strap 20) towards the machine end of the shaft 14 (see Fig. 1, Fig. 2, paragraph [0028]), the mounting flange 20 extending radially outwardly of the tube 14 and being provided with an opening towards each end (a pair of strap openings 26, Fig. 2) to which means (tie 30) can be secured to retain the tube with the patient's neck (see Fig. 1, paragraphs [0031]-[0032]), characterised in that the flange 20 is of a first silicone material (paragraph [0030]) overmoulded on two reinforcement inserts 50 (Fig. 3, Fig. 4, paragraph [0034]) at respective ones of the openings 26 (paragraph [0042] describes an overmolding process where the flange/neck strap 20 material is in a pliable/liquid state when the reinforcing inserts/members 50 are inserted therein, the pliable liquid material flowing around the inserts/members 50 before solidifying and bonding to the inserts/members 50).
Depel further discloses that the reinforcement inserts/members 30 are a different material than the first silicone material (paragraph [0030]: In one example, the body portion 22 of the neck strap 20 includes a deformable material that is readily flexible and can flex (e.g., bend, curve, etc.) in response to a contour and shape of the patient's neck. The neck strap 20 can include, for example, a silicone material, though other materials, such as elastomeric materials, polymeric, or other soft materials that can be molded, are envisioned that may minimize irritation to the patient 12. In other examples, the body portion 22 can include an elastomeric, polymeric material or the like. paragraph [0037]: The reinforcing member 50 includes a rigid or substantially rigid material. The reinforcing member 50 includes, for example, polymer, plastic, metal, nylon or the like. In one example, the reinforcing member 50 is more rigid/stiff than the neck strap 20), but does not disclose that the material of the reinforcing inserts/members 50 are of a heat-cured silicone rubber material different from the first silicone material.
Applicant, in the specification at page 2, discloses the problem of using different materials for the inserts and the flange is that the flange often separates from the inserts because of their differing materials. Using the heat cured silicone rubber as the insert material results in a similar hardness of the inserts and the flange, preventing such separation. Thus, given that Depel desires a more rigid material for the reinforcing inserts 50 and a more soft, flexible material for the neck strap, it would not have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to have modified Depel’s more rigid material to be a heat cured silicone rubber material, as claimed.
Claims 19 and 22 similarly include a mounting flange having two inserts of heat-cured silicone rubber material overmolded with a silicone material different from that of the inserts. Thus, claims 19 and 22 are allowable for the same reasons as claim 12.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Coates (US 20090288665) discloses a tracheostomy tube (Fig. 1, Fig. 2) including a flange 2 molded from silicone about a coupling 4, which is of harder material, Fig. 1, Fig. 2, paragraph [0017]).
Bales (US 5054482 A) discloses a tracheostomy tube having a flange 22 and reinforcement ribs 34 including openings 30 for attaching a neck strap and further discloses connector tabs 19 made of a different material than the flange 22 (col. 3, ln. 62 – col. 4, ln. 14).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 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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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785