DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the AIA first to file provisions. 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 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.
Application Status
This office action is in response to the claims filed 4/10/2024.
Claims 1-16 are currently pending and being examined.
Information Disclosure Statement
The IDS filed on 4/10/2024 has been considered. See the attached PTO 1449 forms.
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 limitations are:
“a plurality of supporting features to secure and protect the bioprocessing bag and the impeller” in claims 1 and 9, which is being interpreted to encompass ribs and equivalents thereof. This is also applicable to the “supporting structures” of claims 6, 7, 14, and 15 (see 112(b) section above).
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 Objections
Claims 6, 8, 14, and 16 recite “claim shell” which should be changed to “clam shell”.
In claim 9 “wherein bioprocessing bag” should be changed to “wherein the bioprocessing bag”.
Appropriate correction is required.
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 1-8, 10-11, and 14-15 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 1 recites “when placed in the packaging”, which is indefinite because “the packaging” lacks sufficient antecedent basis. It is unclear if this is intended to be “when placed in the apparatus”. If that is not the case, the instances of “The apparatus” in the dependent claims would be unclear.
Claims 3 and 11 recite “the cutout of the bottom shell is elongated, and the cutout of the bottom shell is round” which is indefinite because it is unclear how something can be elongated and round simultaneously. Examiner notes that the disclosure states the top shell is round.
Claim 6, 7, 14, and 15 recite “the supporting structures”, which lack antecedent basis, but are interpreted to be “the supporting features” of claims 1 and 9.
Claims 2 and 10 recite “disposed about the interior”, which is indefinite because the meaning of disposed about an interior is generally unclear.
Claims dependent on the above claims are therefore also rejected as being dependent on a rejected claim.
Allowable Subject Matter
Claims 9, 12, and 13 are allowed.
Claim 1 would be allowable if rewritten 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.
Claims 2-8, 10-11, and 14-16 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
The following is an Examiner’s statement of reasons for indicating claims 1 and 9 allowable: the prior art has been found to disclose related packaging systems and apparatuses for bioprocessing bags (e.g., see prior art of made record). For example, Forsberg et al. US 2021/0198002 teaches a bioprocessing bag (20) having an impeller (28) disposed within the bioprocessing bag, but stores the same in a general packaging container (100). McDowell US 2009/0114311 discloses a clam shell structure (12) to receive a portion of a bag (14) in a folded state, the clam shell structure including: a bottom shell (bottom 21); a top shell (top 21) that mates with the bottom shell, the mated bottom shell and top shell defining an interior portion with an opening (at 28) extending therethrough to receive at least a portion of the folded bag; and wherein the bottom shell and the top shell each has a plurality of supporting features (i.e., various panels) to secure and protect the bag received in the clam shell structure. The prior art as a whole fails to disclose the claimed clam shell structure in combination with the bioprocessing bag wherein the impeller, when placed in the packaging, is centrally disposed in the interior portion and a portion of the bioprocessing bag extends out from the opening of the clam shell structure. Upon examination, the art considered as a whole, alone or in combination, neither anticipates nor renders obvious the invention as claimed. It is Examiner's opinion that it would not have been obvious to one having ordinary skill in the art at the time of the invention to combine or modify the prior art in order to arrive at Applicant's claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: for example, see Kronenberg US 2019/0292506; Seal et al. US 2016/0303567; Corten US 10,597,211; and others provided in the PTO-892.
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/DARIUSH SEIF/Primary Examiner, Art Unit 3731
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