DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Note: the second non-final has been submitted to address the 35 USC 112(b) clarity issues below.
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.
The following claim limitations
At least one means (claims 1 and 36)
A control function (claims 1 and 36)
An interface function (claims 1 and 36)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Means (At least one means - claims 1 and 36)
Function (A control function - claims 1 and 36)
Function (An interface function - claims 1 and 36)
coupled with functional language
the drug storage bag or storage bag set is customized (At least one means - claims 1 and 36)
for the patient’s identification and administration route verification before administration start up (A control function - claims 1 and 36)
through which an administration protocol comprising patient identification… (An interface function - claims 1 and 36)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1 and 36 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
see the 35 USC 112(b) claim rejection below (At least one means - claims 1 and 36)
see the 35 USC 112(b) claim rejection below (A control function - claims 1 and 36)
see the 35 USC 112(b) claim rejection below (An interface function - claims 1 and 36)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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, 2-5, 7-8, 10, 36, 39-41 and 43 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.
Regarding claim 1:
The claim recites the limitation "the infusion protocol" in line 32. There is insufficient antecedent basis for this limitation in the claim.
The limitation “at least one means”, “control function” and “interface function” in claim 1 is unclear. These limitations are unclear because they have been interpreted to invoke 35 USC 112(f) however the specification fails to disclose what the structure are for these limitations. For these reasons, the limitations are unclear. For the sake of examination, the limitation “at least one means” has been interpreted to refer to a label or identification structure, “control function” has been interpreted to refer to a software or program for performing the function and “interface function” has been interpreted to refer to a software or program for performing the function.
Claims 2-5, 7, 8, 10, 39 and 41 are rejected due to their dependence on claim 1.
Regarding claim 36:
The claim recites the limitation "the infusion protocol" in line 30. There is insufficient antecedent basis for this limitation in the claim.
The limitation “at least one means”, “control function” and “interface function” in claim 1 is unclear. These limitations are unclear because they have been interpreted to invoke 35 USC 112(f) however the specification fails to disclose what the structure are for these limitations. For these reasons, the limitations are unclear. For the sake of examination, the limitation “at least one means” has been interpreted to refer to a label or identification structure, “control function” has been interpreted to refer to a software or program for performing the function and “interface function” has been interpreted to refer to a software or program for performing the function.
Claims 40 and 43 are rejected due to their dependence on claim 36.
Regarding claim 41:
The claim recites the limitation "the adapter" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The limitation “luer connector” is unclear because claim one (on which this claim depends) already includes a connector in line 9 and these two structures overlap. For the sake of examination, the office has assumed that these structures are one and the same however the applicant should amend the claim to clarify.
Regarding claim 43:
The claim recites the limitation "the adapter" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The limitation “luer connector” is unclear because claim 36 (on which this claim depends) already includes a connector in line 10 and these two structures overlap. For the sake of examination, the office has assumed that these structures are one and the same however the applicant should amend the claim to clarify.
Allowable Subject Matter
Claims 1-5, 7, 8, 10, 36, 39-41 and 43 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.
Furthermore, the prior art of record does not teach “wherein the drug storage bag is connected to the pump via a connector and where in the drug bag is disposed within the cavity” and “the storage bag or storage bag set comprises a label/marking, providing information in a visual and/or wireless way to pump directly or through the internet” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 1; and
the prior art of record does not teach “wherein the drug storage bag is connected to the pump via connector where in the drug storage bag is disposed within the cavity” and “the storage bag or storage bag set comprises a label/marking, providing information in a visual and/or wireless way to pump directly or through the internet” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 36.
Therefore, the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments, see remarks, filed 9/5/25, with respect to the non-final office action filed 5/8/25 have been fully considered and are persuasive.
Regarding the 35 USC 112 (b) claim rejections:
The applicant's amendments to the claims have addressed the previous claim rejections and for this reason they are withdrawn. However, the applicant's amendments to the claims have created new clarity issues which have been rejected above.
Regarding the claim objections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason the objections have been withdrawn.
Regarding the 35 USC 103 claim rejections:
The applicant's amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
