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 .
DETAILED ACTION
Claim Objections
Claims 1-10 are objected to because of the following informalities:
in line 10 of Claim 1, delete “and” before “wherein”;
in line 12 of Claim 1, delete “and” before “wherein”;
in line 13 of Claim 1, insert --and-- after “350 keV,”;
in line 14 of Claim 1, delete “and” before “wherein”;
in line 4 of Claim 9, delete “m2kg/m2” and insert --m2kg/m2--;
in line 6 of Claim 9, delete “m2kg/m2” and insert --m2kg/m2--.
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. Such claim limitation(s) is/are: “production apparatus” and “conveying device” in claim 1.
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. The corresponding structure for “a production apparatus” includes a production module and a packaging machine, or an automated (packaging) machine arrangement that produce wound dressings and that cuts the materials (see published application, p. 1 [0011] and [0019]). The corresponding structure for “a conveying device” includes driven and non-driven rollers and/or conveyor belts such as a chain link belt made of metal, or possesses ribs or elevations extending across the direction of transport, with or without vacuum assistance (see published application, p. 2 [0026]-[0029]).
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “sterilization module” in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 the limitation "the packaged wound dressings" in lines 10 and 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the electron radiation" in line 12. There is insufficient antecedent basis for this limitation in the claim.
In Claim 1, it is not clear whether the speed at which the conveying device moves the packaged wound dressings are at “m/min” or “min/m” as set forth in the last line.
Claim 2 recites the limitation "the wound dressing packagings" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the sterilization" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the shielding" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the wound dressing" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the wound dressing" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Claims 4-5, 7 and 9 are rejected due to their dependence on a rejected claim.
Allowable Subject Matter
Claim 1 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: the primary reason for indication of allowable subject matter is due to inclusion of structures (i.e. “production apparatus” and “conveying device”) set forth and interpreted under 35 U.S.C. 112(f) along with at least one electron beam source for a sterilization module that is “coupled in-line to the production apparatus” and inclusion of process steps of “the energy dose to which the packaged wound dressings are exposed is at least 15 kGy and no more than 30 kGy”, “the energy of the electron radiation is between 150 keV and 350 keV” and “the conveying device moves the packaged wound dressing at a speed of at least 10 m/min and no more than 200 min/m” . While prior art such as Buckman (20080132820) discloses that a wound dressing (1) is “packaged in a sealed, sterile barrier package and is sterilized using standard techniques such as … electron beam” (see entire document, particularly p. 4 [0055]), Buckman (‘820) does not specifically teach neither a production apparatus or a conveying device as interpreted under 35 U.S.C. 112(f) nor at least one electron beam source for a sterilization module that is coupled in-line to the production apparatus” “wherein the energy dose to which the packaged wound dressings are exposed is at least 15 kGy and no more than 30 kGy”, “wherein the energy of the electron radiation is between 150 keV and 350 keV” and “wherein the conveying device moves the packaged wound dressing at a speed of at least 10 m/min and no more than 200 min/m”.
Prior art of Inoue (JP3344556) discloses a method of sterilization of a packaged wound dressing comprising steps of hermetically packaging a wound dressing and irradiating with an electron beam with an energy dose of 10 kGy or less (see entire English translation, particularly p. 4 lines 21, 23-24 and 28), Inoue (‘556) does not specifically teach neither a production apparatus or a conveying device as interpreted under 35 U.S.C. 112(f) nor at least one electron beam source for a sterilization module that is coupled in-line to the production apparatus” “wherein the energy dose to which the packaged wound dressings are exposed is at least 15 kGy and no more than 30 kGy”, “wherein the energy of the electron radiation is between 150 keV and 350 keV” and “wherein the conveying device moves the packaged wound dressing at a speed of at least 10 m/min and no more than 200 min/m”.
Prior art of Kaneko (WO2009139304) discloses a method in-line sterilization of a packaged medical device (see Figures 1-2) comprising steps of: providing a packaged medical device (7, 9) (i.e. left-most step - see Figure 1), conveying the packaged medical device by means of a conveying device (5) to a sterilization module (2) (i.e. middle step - see Figure 1), sterilizing the packaged medical device by means of at lest one electron beam source (2) present in the sterilization module (2) (i.e. last/right-most step - see Figure 1), wherein the sterilization module (2) is coupled in-line to a packaging apparatus (8) (see Figure 1), a) wherein the energy dose to which the packaged medical device are exposed is at least 15 kGy and no more than 30 kGy (see entire English translation, particularly p. 8 lines 8 and 12-17, p. 10 – 15th -16th lines from the bottom), Kaneko (‘304) does not specifically teach a “production apparatus” as interpreted by 35 U.S.C. 112(f), or that “the energy of the electron radiation is between 150 keV and 350 keV”, nor that “the conveying device moves the packaged wound dressing at a speed of at least 10 m/min and no more than 200 min/m”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: 20050165445 (a method of sterilizing a packaged wound dressing comprising steps of packaging a wound dressing (120) and sterilizing the packaged wound dressing with electron beam (see entire document, particularly p. 8 [0084])), CN106806934 (a method of sterilizing a packaged wound dressing with electron beam irradiation using 25 kGy dose), 20130012901 (a method of sterilizing a wound dressing with electron beam irradiation using 25-35 kGy dose), CN1273128 (a method of sterilizing a wound dressing with electron beam irradiation using 25-50 kGy dose), JP2014526915 (a method of sterilizing a packaged medical device/stent delivery system with electron beam irradiation), JP4486304 and 20090209897 and WO2022064291 (a method of sterilizing a packaged wound dressing with electron beam irradiation).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758
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