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 Objections
Claim 2 is objected to because of the following informalities: the word “energies” in line 2 of claim 2 should be --an energy--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the claim depends on itself as “claim 8” is recited in line 1. Appropriate correction is required. It is noted that both claims 9 and 10 recited dependency on claim 8.
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.
In regard to claim 1, the phase “emitting at least one electron beam with energy between 400 and 500 keV” is unclear as, using the broadest reasonable interpretation, the phase allows for multiple electron beams with the recited energy level to be overlayed which would result in a combined electron beam having a multiple of the recited energy for each of the emitted electron beams. For the purpose of examination, the limitation will be interpreted as --emitting an electron beam with energy between 400 and 500 keV--.
In regard to claim 1, the phrase “emitting at least a second electron beam pulse” is indefinite as it is unclear how to interpret the use of the phrase “at least” and the limitation refers to a “second” electron beam “pulse” when a first pulse is not recited. Does the phrase mean that more than one of the second electron beam pulses with the recited energy level can be emitted or that an electron beam pulse with a different energy level can be emitted? Also, does the phrase imply that the “at least one electron beam” is also applied in the form of a pulse? For the purpose of examination, the limitation will be interpreted as --emitting a second electron beam--.
Claim 2 recites the limitation "said second accelerator" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "said second accelerator" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the flexible bag to be sterilized" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 1 recites “flexible bags” while the instant claim is reciting an individual flexible bag. Therefore, either claim 1 or claim 4 should be amended to clarify that one bag is sterilized at a time.
Claim 4 recites the limitation "the irradiation source" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the irradiation source" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the accelerators" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the device" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the electron beam" in line 2. There is insufficient antecedent basis for this limitation in the claim. The Examiner is unable to determine which limitation of claim 1 is referenced by the above recitation as claim 1 recites “at least one electron beam” and “a second electron beam pulse.”
Claim 8 recites the limitation "the pharmaceutical solution of biological origin" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
The remaining claims are rejected based upon their dependency on a claim rejected above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regard to claim 7, the claim is in improper dependent form for failing to include all the limitations of claim 1. Claim 1 explicitly recites a “method for sterilization of flexible bags containing human plasma protein solution” (emphasis added) which means that the bags must already contain the solution. Claim 7 optionally allows for the method to “be performed before […] bag filling” which is broader than the recited method of claim 1. It is additionally noted that should the “before” option be deleted from claim 7, the claim would fail to further limit the subject matter of claim 1 as claim 1 already requires that the method is performed “after bag filling.” As such, the Examiner recommends cancelling the claim.
In regard to claim 10, the claim is in improper dependent form for failing to include all the limitations of claim 8 which is assumed to be intended to recite dependency on or from claim 1. Claim 1 explicitly recites a “method for sterilization of flexible bags containing human plasma protein solution” (emphasis added) which means that the bags must already contain the solution. Claim 10, which explicitly assigns order to the recited steps using letters, requires that the step of “c) filling the bags […]” occurs after the step of “b) sterilizing the bags […] according to claim 8” which claim 1 requires that the bags already contain the solution when sterilized.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1-6 and 8-9 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 prior art fails to teach, suggest or render obvious a method of sterilization of flexible bags using electron beams having the recited energies wherein emission of the electron beams is separated by the recited time period. The closest prior art of record was determined to be Galloway (2005/0112248) and WO 2018167334. Galloway discloses the use of multiple electron accelerators which produce an energy between 500 keV and 4.0 MeV for reducing pathogens on animal carcasses which one of ordinary skill in the art would not have been motivated to use in the sterilization of flexible bags containing human plasma protein solution. WO 2018167334 discloses a device for sterilization of flexible bags using two different energy levels of electron beams but does not disclose the energy range of “at least 4 MeV” as the second energy level is taught to be 700-750 keV which is sufficient to penetrate the outlet of the flexible bag. One of ordinary skill in the art would not have been motivated to have increased the second energy level to the recited “at least 4.0 MeV” without impermissible hindsight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY C CLEVELAND whose telephone number is (571)270-5041. The examiner can normally be reached M-F 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY C CLEVELAND/Primary Examiner, Art Unit 1774
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