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 .
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11 and 15-21, drawn to a system, classified in A61M 5/145.
II. Claims 13, 14, drawn to a method, classified in A61M 37/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed can be used in a materially different process of using that product such as using a method to selectively fill the bottles with either one fluid or a mixture of two fluids.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) The inventions have acquired a separate status in the art due to their recognized divergent subject matter.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
This application contains claims directed to the following patentably distinct species:
Species A: Figures 1-18B
Species B: Figures 19-34
Species C: The system or method of suitable for delivering a therapeutic agent to a target site comprising the switch shown in figure 35.
Species D: The system or method of suitable for delivering a therapeutic agent to a target site comprising the switch shown in figures 36-37.
Species E: The system or method of suitable for delivering a therapeutic agent to a target site comprising the switch shown in figure 38-41.
The species are independent or distinct because each species discloses different structure of the switches. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1, 13 and 14 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Douglas Oguss on 7/10/2025 a provisional election was made with traverse to prosecute the invention of Invention I, Species B (figures 19-34), claims 1-8 and 10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9, 11 and 13-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement filed 5/1/2023 and 11/26/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claims 4, 5 are objected to because of the following informalities:
Claim 4 recites the limitation “the button” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the button” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the first state” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the second state” in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 3, 8 and 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.
Regarding claim 3, the limitation “a second valve” in line 1 renders the claim indefinite because the claim is unclear if the claim is positively reciting the system to include “a first valve” or if the claim only includes a second valve. For examination purposes, examiner construes “a first valve” is present.
Regarding claim 8, the limitation “a retracted position and an extended position” renders the claim indefinite because the claim is unclear regarding whether “a retracted position and an extended position” is same as “a first position and a second position” recited in claim 1, line 10. For examination purposes, examiner construes that “a retracted position” in claim 8 is same as “a first position” recited in claim 1 and “an extended position” in claim 8 is same as “a second position” in claim 1.
Regarding claim 10, the limitation “an extended position and a retracted position” renders the claim indefinite because the claim is unclear regarding whether “an extended position and a retracted position” is same as “a first position and a second position” recited in claim 1, line 10. For examination purposes, examiner construes that “an extended position” in claim 10 is same as “a first position” recited in claim 1 and “a retracted position” in claim 10 is same as “a second position” in claim 1.
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, 3, 7, 8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PIC et al. (US 2020/0100986 A1).
Regarding claim 1, PIC teaches a system 10 (figure 2) suitable for delivering a therapeutic agent (agent contained in element 106) to a target site, the system comprising:
a container 100 for holding a therapeutic agent (paragraph 0198, lines 10-11);
a pressure source 20’ having pressurized fluid (paragraph 0173, lines 1-5), the pressure source 20’ in selective fluid communication with at least a portion of the container 100 (paragraph 0138, lines 1-4, paragraph 0141, lines 10-13);
a catheter 190 in selective fluid communication with the container 100 and configured for delivery of the therapeutic agent or the pressurized fluid to a target site; and
a housing (housing of element 10) configured to securely retain the container 100 and movably support a switch 36a, 36b,
wherein the switch 36a, 36b is movable between a first position (position where element 36b is pressed and 36a is unpressed) and a second position (position where element 36a is pressed and 36b is unpressed),
wherein when the switch 36a, 36b is in the first position, delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted (paragraph 0142, lines 1-11), and
wherein when the switch 36a, 36b is in the second position, delivery of the therapeutic agent is permitted (paragraph 0142, lines 13-27).
Regarding claim 3, PIC teaches further comprising a second valve (structure inside element 36a that allows fluid to either stay in fluid communication or not stay in fluid communication with element 100) connected between the container 100 and the catheter 190, wherein when the second valve is in a first state (state of the structure inside element 36a when element 36a is unpressed), the catheter is not in fluid communication with the container, and wherein when the second valve is in a second state (state of the structure inside element 36a when element 36a is pressed, paragraph 0142, lines 13-27), the catheter 190 is in fluid communication with the container 100.
Regarding claim 7, PIC teaches wherein the switch 36a, 36b comprises a slider (structure that supports movement of elements 36a, 36b) and the housing (housing of element 10) is configured to slidably support the slider (housing of element 10 is capable to hold/support the slider).
Regarding claim 8, PIC teaches wherein the switch 36a, 36b is movable between a retracted position (position where element 36b is pressed and 36a is unpressed) and an extended position (position where element 36a is pressed and 36b is unpressed), wherein when the switch is in the retracted position (paragraph 0142, lines 1-11), delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted, and wherein when the switch is in the extended position (paragraph 0142, lines 13-27), delivery of the therapeutic agent is permitted.
Regarding claim 10, PIC teaches wherein the switch 36a, 36b is movable between an extended position (position where element 36b is pressed and 36a is unpressed) and a retracted position (position where element 36a is pressed and 36b is unpressed), wherein when the switch is in the extended position (paragraph 0142, lines 1-11), delivery of the therapeutic agent is prevented while delivery of the pressurized fluid is permitted, and wherein when the switch is in the retracted position (paragraph 0142, lines 13-27), delivery of the therapeutic agent is permitted.
Allowable Subject Matter
Claims 2 and 4-6 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record, PIC et al. (US 2020/0100986 A1), is silent regarding wherein when the switch is in the first position, the switch allows the button to be depressed to a first state, allowing the pressurized fluid in the pressure source to flow through the first valve and into the catheter absent delivery of the therapeutic agent, and wherein when the switch is in the second position, the switch allows the button to be depressed to a second state, allowing the pressurized fluid in the pressure source to flow through the first valve, into the container, and urge the therapeutic agent int the container through the catheter in combination with other claimed limitations of claim 2.
The closest prior art of record, PIC et al. (US 2020/0100986 A1), is silent regarding wherein when the switch is in the first position, the switch blocks the button such that the button can be moved distally a maximum of a first distance, wherein when the switch is in the second position, the switch allows the button to be moved distally a maximum of a second distance, and wherein the first distance is smaller than the second distance in combination with other claimed limitations of claim 4.
The closest prior art of record, PIC et al. (US 2020/0100986 A1), is silent regarding wherein the switch is in the first position, the switch occupies a space, and wherein the space, when not occupied, allows movement of the button from the first state to the second state in combination with other claimed limitations of claim 5.
Claim 6 being dependent on claim 5 is also indicated allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lampert et al. (US 2015/0265784 A1): discloses a design of a system comprising a switch to selectively deliver the fluid either with or without a flushing liquid.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783