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 .
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 10/18/2023, 01/22/2024, and 06/20/2024, have been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the cassette assembly comprising “a housing defining an internal volume” (as recited in claims 1 and 11) and “wherein each pre-filled syringe includes a plunger; and each plunger is positioned to receive a force from a syringe pump driver” (as recited in claims 4 and 14) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: In order to maintain clarity, the phrase “a manifold in fluid connection with each of the reservoirs” should be changed to “a manifold in fluid connection with each of the plurality of reservoirs.” 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: “communication device” in claim 19.
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 1-20 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.
[Claims 1 and 11] The claims recite the limitation of “the other reservoirs.” There is a lack of antecedent basis for this limitation in the claims. Further, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if this limitation refers to each reservoir of the plurality of reservoirs that is not the flush reservoir, or if the intention is a particular subset of the plurality of reservoirs that is not the flush reservoir. For purposes of examination, it is interpreted that the limitation should recite “each remaining reservoir of the plurality of reservoirs.”
[Claims 1 and 11] The claims recite the limitation of “the delivery line adapted to deliver a fluid.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “flush fluid,” fluid from the remaining reservoirs, or any combination of fluids present in the assembly. For purposes of examination, it is interpreted that “a fluid” refers to any combination of fluids present in the assembly.
[Claim 6] The claim recites the limitation of “the plurality of reservoirs includes a plurality of medication reservoirs; and each of the medication reservoirs contains a different medication.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the limitation is intending to require each reservoir of “the plurality of reservoirs” to have additional subdivisions of reservoirs (wherein each subdivision would have a different medication), or if the intention is simply to require that each of the plurality of reservoirs contains a different medication. For purposes of examination, it is interpreted that the limitation only requires that each of the plurality of reservoirs contains a different medication.
[Claims 9 and 15] The claims recite the limitation of “wherein the delivery line is fluidically coupled to a patient via patient via one of an intravenous or intraosseous needle.” The examiner is unable to determine the metes and bounds of the claims, since it is unclear if the phrasing is intending to require multiple patients, or if a typographical error is present. For purposes of examination, it is interpreted that the limitation was intended to recite “wherein the delivery line is fluidically coupled to a patient via one of an intravenous or intraosseous needle.”
[Claim 10] The claim recites “wherein an external fluid reservoir is fluidically coupled to the delivery line.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear how the limitation of “external” is to be interpreted. Specifically, it is unclear if the “external fluid reservoir” is meant to be “external” of a particular structure or the “cassette assembly” itself. Furthermore, as the claims are directed to “a cassette assembly,” it would be unclear how a positive recitation of an “external fluid reservoir” could be included with the cassette assembly. For purposes of examination, it is interpreted that the claim should recite “wherein the delivery line is configured to be fluidically coupled to an external fluid reservoir.”
[Claim 12] The claim recites the limitation of “the pre-filled syringes include a plurality of medication syringes; and each of the medication syringes contains a different medication.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the limitation is intending to require each syringe of “the pre-filled syringes” to have additional subdivisions of syringes (wherein each subdivision would have a different medication), or if the intention is simply to require that each of the pre-filled syringes contains a different medication. For purposes of examination, it is interpreted that the limitation only requires that each of the pre-filled syringes contains a different medication.
[Claim 16] The claim recites “wherein an external fluid reservoir is fluidically coupled to the delivery line.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear how the limitation of “external” is to be interpreted. Specifically, it is unclear if the “external fluid reservoir” is meant to be “external” of a particular structure, the “cassette assembly”, or the “therapeutic device.” As the claims are directed to a “therapeutic device,” it is unclear if the “external fluid reservoir” is intended to be included as part of said device (and simply external of another interior structure), or if the “external fluid reservoir” is “external” of said device. For purposes of examination, it is interpreted that the “external fluid reservoir” is intended to be included as part of the “therapeutic device,” but external of the “cassette assembly.”
[Claims 2-10 and 12-20] The claims are rejected based upon their dependency from independent claims 1 and 11.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9 and 15 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 9 and 15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
The claims are interpreted as being directed to or encompassing a human organism due to the recitation of “wherein the delivery line is fluidically coupled to a patient.” The examiner suggests the limitation be amended to recite “wherein the delivery line is configured to be fluidically coupled to a patient.”
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 8-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patrick et al. (PGPub 2011/0306932).
[Claims 1 and 11] Patrick teaches a therapeutic device (figure 7d, items 100/300) comprising:
a cassette assembly (figure 7a, item 300);
a chassis (figure 13a, item 110), the chassis defining a slot configured to receive the cassette assembly (as shown in figure 7d);
a drive assembly (figure 13a, items 180/190) positioned within the chassis (figure 13a, item 110), the drive assembly (figure 13a, items 180/190) including a plurality of drive members (figure 13a, item 190) configured to convey a dose of medicament from the cassette assembly (figure 7a, item 300) (paragraphs [0277]-[0279]); and
the cassette assembly (figure 7a, item 300) including:
a housing (figure 7a, item 302) defining an internal volume (figure 7a; paragraph [0248]),
a plurality of reservoirs (figure 7a, item 360) positioned within the internal volume (figure 7a), one of the plurality of reservoirs being a flush reservoir (figure 7a, item 360) (The examiner notes the term “flush reservoir” has not been explicitly defined; as such, lacking any further claimed limitations, the term “flush reservoir” does not impart any structural limitations which differ from the term “reservoir.” Given this, any one of the reservoirs taught by Patrick can be considered to be a “flush reservoir.”), the flush reservoir containing a flush fluid (paragraph [0249]) (again, lacking any explicit definition for the term “flush fluid” or further limitations, the limitation can be met by any fluid within the reservoir), the plurality of reservoirs (figure 7a, item 360) being operably coupled to the plurality of drive members (figure 13a, item 190) on a condition that the cassette assembly (figure 7a, item 300) is received by the slot of the chassis (figure 13a, item 110) (figure 7d; paragraphs [0249], [0277]-[0279]),
a manifold (figure 7a, item 330) in fluid connection with each of the reservoirs (figure 7a, item 360) on a condition that the cassette assembly (figure 7a, item 300) is operably coupled to the chassis (figure 13a, item 110), the flush reservoir (figure 7a, item 360) being fluidly coupled to the manifold (figure 7a, item 330) upstream of a coupling location (figure 7b, item 252) for each of the other reservoirs (see 112b interpretation above) (figure 7a, item 360) of the plurality of reservoirs (figure 7a, item 360) (figure 7b), and
a delivery line (figure 7b, item 250) fluidically coupled to the manifold (figure 7a, item 330), the delivery line (figure 7b, item 250) adapted to deliver a fluid (figure 7b; paragraph [0252]).
[Claims 1 and 8] (Alternative interpretation for purposes of claim 8 only) Patrick teaches a cassette assembly (figure 7d, item 300) configured to be operatively coupled to a chassis (figure 13a, item 110) of a therapeutic device (figure 7d, item 100), the cassette assembly (figure 7d, item 300) comprising:
a housing (figure 7a, item 302) defining an internal volume (figure 7a; paragraph [0248]),
a plurality of reservoirs (figure 14b, items 400a/400b/400c) positioned within the internal volume (figure 14b) (The examiner notes an “internal volume” has not been explicitly defined; thus, reservoirs positioned within the boundary of the housing would meet this limitation. However, it is further noted that “nest” structures 370, as shown in figure 14b, could be considered as part of the housing 302.), one of the plurality of reservoirs being a flush reservoir (figure 14b, items 400a/400b/400c) (The examiner notes the term “flush reservoir” has not been explicitly defined; as such, lacking any further claimed limitations, the term “flush reservoir” does not impart any structural limitations which differ from the term “reservoir.” Given this, any one of the reservoirs taught by Patrick can be considered to be a “flush reservoir.”), the flush reservoir containing a flush fluid (paragraph [0200]) (again, lacking any explicit definition for the term “flush fluid” or further limitations, the limitation can be met by any fluid within the reservoir),
wherein each reservoir of the plurality of reservoirs (figure 14b, items 400a/400b/400c) includes a membrane (figure 8, item 410) configured to be punctured by a penetrating instrument (figure 8, item 332) (figure 8; paragraph [0256]);
a manifold (figure 8, item 330) in fluid connection with each of the reservoirs (figure 14b, items 400a/400b/400c) on a condition that the cassette assembly (figure 7d, item 300) is operably coupled to the chassis (figure 13a, item 110), the flush reservoir (figure 14b, items 400a/400b/400c) being fluidly coupled to the manifold (figure 8, item 330) upstream of a coupling location (figure 7b, item 252) for each of the other reservoirs (see 112b interpretation above) (figure 14b, items 400a/400b/400c) of the plurality of reservoirs (figure 14b, items 400a/400b/400c) (figure 7b), and
a delivery line (figure 7b, item 250) fluidically coupled to the manifold (figure 8, item 330), the delivery line (figure 7b, item 250) adapted to deliver a fluid (figure 7b; paragraph [0252]).
[Claim 2] Patrick teaches the limitations of claim 1, upon which claim 2 depends. In addition, Patrick discloses each of the plurality of reservoirs (figure 7a, item 360) is coupled to the manifold (figure 7a, item 330) by a different one-way valve (figure 8, item 350) (figure 8; paragraph [0257]).
[Claims 3, 4, 6, 12, and 14] Patrick teaches the limitations of claims 1 and 11, upon which claims 3, 4, 6, 12, and 14, depend. Patrick also teaches
each reservoir of the plurality of reservoirs (figure 7a, item 360) is a pre-filled syringe (paragraph [0249]) containing a different medication (paragraphs [0008], [0009]);
wherein each pre-filled syringe (figure 7a, item 360) includes a plunger (figure 7a, item 364) (figure 7a; paragraph [0249]); and
each plunger (figure 7a, item 364) is positioned to receive a force from a syringe pump driver (figure 13a, item 190) of the chassis (figure 13a, item 110) (paragraphs [0249], [0251], [0277]-[0279]).
[Claims 5 and 13] Patrick teaches the limitations of claims 1 and 11, upon which claims 5 and 13 depend. Patrick further discloses each pre-filled syringe (figure 7a, item 360) is independently actuatable (figure 7b; paragraph [0249], [0251], [0277]-[0279]).
[Claims 9 and 15] Patrick teaches the limitations of claims 1 and 11, upon which claims 9 and 15 depend. Patrick also teaches the delivery line (figure 7b, item 250) is configured to be (see 112b interpretation above) coupled to a patient via one of an intravenous or intraosseous needle (figure 1, item 290) (the examiner notes the needle is interpreted as functionally recited) (figure 1; paragraph [0252]).
[Claims 10 and 16] Patrick teaches the limitations of claims 9 and 11, upon which claims 10 and 16 depend. Patrick further discloses an external fluid reservoir (figure 8, item 400) is fluidically coupled to the delivery line (figure 7b, item 250).
[Claim 17] Patrick teaches the limitations of claim 1, upon which claim 17 depends. In addition, Patrick teaches
the chassis (figure 13a, item 110) includes an electronic component system including a processor operably coupled to a memory storing processing instructions to interpret a plurality of parameters and control delivery of the medicament (paragraphs [0215], [0216], [0415], [0422]); and
the plurality of parameters are associated with a medical intervention in response to an acute medical condition (paragraphs [0422], [0430]).
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bochenko et al. (PGPub 2010/0022987).
[Claims 1 and 11] Bochenko teaches a therapeutic device (figure 1, item 2) comprising:
a cassette assembly (figure 1, item 8; paragraph [0044]);
a chassis (figure 4c, item 42), the chassis defining a slot (figure 1, item 18; paragraph [0045]) configured to receive the cassette assembly (figure 4c; paragraph [0071]);
a drive assembly (figure 4b, items 70/74/75) positioned within the chassis, the drive assembly (figure 4b, items 70/74/75) including a plurality of drive members (figure 4b, item 70) configured to convey a dose of medicament from the cassette assembly (figure 1, item 8) (figures 6a-6e; paragraph [0075]); and
the cassette assembly (figure 1, item 8) including:
a housing defining an internal volume (figure 3a),
a plurality of reservoirs (figure 1, item 6) positioned within the internal volume (figure 1), one of the plurality of reservoirs being a flush reservoir (figure 1, item 6) (The examiner notes the term “flush reservoir” has not been explicitly defined; as such, lacking any further claimed limitations, the term “flush reservoir” does not impart any structural limitations which differ from the term “reservoir.” Given this, any one of the reservoirs taught by Bochenko can be considered to be a “flush reservoir.”), the flush reservoir (figure 1, item 6) containing a flush fluid (figure 6a, item 68; paragraph [0074], [0077]) (again, lacking any explicit definition for the term “flush fluid” or further limitations, the limitation can be met by any fluid within the reservoir), the plurality of reservoirs (figure 1, item 6) being operably coupled to the plurality of drive members (figure 4b, item 70) on a condition that the cassette assembly (figure 1, item 8) is received by the slot (figure 1, item 18) of the chassis (figure 4c, item 42),
a manifold (figure 1, item 4) in fluid connection with each of the reservoirs (figure 1, item 6) on a condition that the cassette assembly (figure 1, item 8) is operably coupled to the chassis (figure 4c, item 42), the flush reservoir (figure 1, item 6) being fluidly coupled to the manifold (figure 1, item 4) upstream of a coupling location (as shown in figure 1) for each of the other reservoirs (figure 1, item 6) (see 112b interpretation above) of the plurality of reservoirs (figure 1, item 6) (figure 1), and
a delivery line (figure 1, item 16) fluidically coupled to the manifold (figure 1, item 4), the delivery line (figure 1, item 16) adapted to deliver a fluid (figure 1; paragraph [0044]).
[Claim 2] Bochenko teaches the limitations of claim 1, upon which claim 2 depends. In addition, Bochenko discloses each of the plurality of reservoirs (figure 1, item 6) is coupled to the manifold (figure 1, item 4) by a different one-way valve (figure 5, item 58) (figure 5; paragraph [0073]).
[Claims 3, 4, 6, 12, and 14] Bochenko teaches the limitations of claims 1 and 11, upon which claims 3, 4, 6, 12, and 14, depend. Bochenko also teaches
each reservoir of the plurality of reservoirs (figure 1, item 6) is a pre-filled syringe (figure 5, item 44) containing a different medication (Table 1; paragraphs [0044], [0065]);
wherein each pre-filled syringe (figure 5, item 44) includes a plunger (figure 5, item 48); and
each plunger (figure 5, item 48) is positioned to receive a force from a syringe pump driver (figure 4b, item 70) of the chassis (figure 4c, item 42) (figure 5; paragraph [0075]).
[Claims 5 and 13] Bochenko teaches the limitations of claims 1 and 11, upon which claims 5 and 13 depend. Bochenko further discloses each pre-filled syringe (figure 5, item 44) is independently actuatable (figure 4a; paragraph [0069]).
[Claim 7] Bochenko teaches the limitations of claim 6, upon which claim 7 depends. Bochenko also discloses the different medications are associated with a medical intervention in response to a cardiac arrest (paragraphs [0006], [0065]; Table 1).
[Claim 8] Bochenko teaches the limitations of claim 1, upon which claim 8 depends. In addition, Bochenko teaches each reservoir of the plurality of reservoirs (figure 1, item 6) includes a membrane (figure 5, item 66) configured to be punctured by a penetrating instrument (figure 5, items 50/54) (figure 5; paragraphs [0073], [0074]).
[Claims 9 and 15] Bochenko teaches the limitations of claims 1 and 11, upon which claims 9 and 15 depend. Bochenko also teaches the delivery line (figure 1, item 16) is configured to be (see 112b interpretation above) coupled to a patient via one of an intravenous or intraosseous needle (the examiner notes the needle is interpreted as functionally recited) (figure 1; paragraph [0044]).
[Claims 10 and 16] Bochenko teaches the limitations of claims 9 and 11, upon which claims 10 and 16 depend. Bochenko further discloses an external fluid reservoir (figure 1, item 12) is fluidically coupled to the delivery line (figure 1, item 16) (figure 1; paragraphs [0044], [0052]).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (PGPub 2011/0306932), in view of Bochenko et al. (PGPub 2010/0022987).
[Claim 18] Patrick teaches the limitations of claim 17, upon which claim 18 depends. Although disclosing a processor for interpreting a plurality of parameters and controlling delivery of a medicament, Patrick does not specifically disclose instructions specific to recommending medication/dosage, delivery of said dosage, followed by a fluid flush.
However, Bochenko teaches a therapeutic device (figure 1, item 2) comprising a cassette assembly (figure 1, item 8) having a plurality of reservoirs (figure 1, item 6), which operates in conjunction with a drive assembly (figure 2a, item 14b and figure 4b, items 70/74/75), to deliver medicament from said reservoirs (figure 1, item 6) (via a manifold; (figure 1, item 4)) to a patient (figure 1); wherein said device (figure 1, item 2) comprises a processor (figure 1, item 20) configured to:
determining a recommended medication to deliver (paragraph [0049]);
determining a recommended dosage based on the parameters (paragraph [0049]);
actuating a first portion (figures 6a-6e, item 70) of the drive assembly (figure 2a, item 14b and figure 4b, items 70/74/75) operatively coupled to one reservoir (figure 1, item 6) of the plurality of reservoirs (figure 1, item 6) containing a medication to deliver the recommended dosage to the manifold (figure 1, item 4) (paragraph [0077]); and
following the delivery of the recommended dosage to the manifold (figure 1, item 4), actuating a second portion (figure 2a, item 14b) of the drive assembly (figure 2a, item 14b and figure 4b, items 70/74/75) operatively coupled to the flush reservoir (figure 2a, item 14a) to deliver a volume of the of the flush fluid to the manifold (figure 1, item 4) (paragraph [0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the functionality of the processor taught by Patrick, to have utilized the claimed functionality, as taught by Bochenko, in order to provide increased functionality and versatility, by allowing for an automated means by which therapeutic treatment might be delivered to a patient.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Patrick et al. (PGPub 2011/0306932), in view of Stultz (PGPub 2005/0113745).
[Claim 19] Patrick teaches the limitations of claim 17, upon which claim 19 depends. Patrick does not specifically disclose the electronic component system includes a communication device configured to communicate signals regarding actuation of the drive assembly.
However, Stultz teaches a therapeutic device (figure 3, item 12) comprising a plurality of reservoirs (figure 3, items 30a-30n) which operate in conjunction with a drive assembly (figure 3, item 33) for fluid delivery to a patient (figure 3; paragraph [0023]), wherein the device (figure 3, item 12) comprises an electronic component system including a communication device (figure 3, items 20/34/40) configured to communicate signals regarding actuation of the drive assembly (figure 3, item 33) (paragraphs [0026], [0027], [0036] [0038]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the electronic component system taught by Patrick, to have included a communication device, as taught by Stultz, in order to provide increased functionality and control, by allowing for a means by which the therapeutic device might be operated remotely.
[Claim 20] Patrick teaches the limitations of claim 17, upon which claim 20 depends. Although disclosing the use of sensors configured to monitor a plurality of parameters, Patrick does not specifically disclose a sensor including one or more of an electrocardiogram apparatus, a pulse oximeter, and a capnography sensor.
However, Stultz teaches a therapeutic device (figure 3, item 12) comprising a plurality of reservoirs (figure 3, items 30a-30n) which operate in conjunction with a drive assembly (figure 3, item 33) for fluid delivery to a patient (figure 3; paragraph [0023]), wherein the device (figure 3, item 12) comprises at least one sensor (figure 3, items 18a-18m) configured to monitor at least one parameter of the plurality of parameters (paragraphs [0029], [0030]), the sensor (figure 3, items 18a-18m) includes one or more of an electrocardiogram apparatus, a pulse oximeter, and a capnography sensor (paragraphs [0029], [0030]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the device taught by Patrick, to have included the claimed sensor capability, as taught by Stultz, in order to provide increased functionality and versatility, by allowing for a means by which physiological feedback might be utilized to aid in the therapeutic treatment of a patient (Stultz; paragraph [0029]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,806,501. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 11 of the instant application can be found in claim 15 of the patent. The difference between claim 11 of the instant application and claim 15 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 15 of the patent is in effect a “species” of the "generic” invention of claim 11 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 11 of the instant application is anticipated by claim 15 of the patent, it is not patentably distinct from claim 15 of the patent.
Conclusion
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/JASON E FLICK/Primary Examiner, Art Unit 3783 02/21/2026