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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 1-7, drawn to a PCA pump with graphical displays for infusion, classified in A61M2005/14292.
Claims 8-13, drawn to a method for operating a PCA pump with graphical displays for infusion, classified in A61M2005/14292.
Claims 14-15, drawn to a PCA pump with graphical displays for patient history, classified in A61M2205/52.
Claims 16-20, drawn to a method for operating a PCA pump with graphical displays for patient history, classified in A61M2205/52.
The inventions are independent or distinct, each from the other because:
Inventions I-III are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect. In the instant case, inventions I and III, invention I is directed to products for generating graphical displays related to infusion therapy, whereas invention III is directed to products for generating graphical displays for patient historical data that include different processes not capable of use together because inventions I and III process different data sets (drug libraries vs. patient history data) and produce different graphical displays based on those data sets.
Inventions II and IV are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, invention II is directed to processes for generating graphical displays related to infusion therapy, whereas invention IV is directed to processes for generating graphical displays for patient historical data that include different processes not capable of use together because inventions II and IV process different data sets (drug libraries vs. patient history data) and produce different graphical displays based on those data sets.
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In the instant case, the processes of invention II can be practiced by another and materially different pump including peristaltic pumps having reservoir bags.
Inventions I and IV are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In the instant case, the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect. In the instant case, the processes of invention IV can be practiced by another and materially different pump including peristaltic pumps having reservoir bags.
Inventions III and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In the instant case, the processes of invention II can be practiced by another and materially different pump including peristaltic pumps having reservoir bags.
Inventions III and IV are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In the instant case, the processes of invention IV can be practiced by another and materially different pump including peristaltic pumps having reservoir bags.
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 different field of search: Where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries), a different field of search is shown, even though the two are classified together. Here, inventions I and II employ different search queries relative to inventions III and IV, wherein inventions I and II would employ search queries for infusion therapy whereas inventions III and IV would employ search queries for patient history. Additionally, the apparatus claims of inventions I and III would employ different search queries for pump components including an actuator and syringe holder relative to the method claims of inventions II and IV.
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.
During a telephone conversation with Dennis Majewski on May 20, 2026 a provisional election was made without traverse to prosecute the invention of group I, claims 1-7. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-20 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.
Claim Objections
Claim 1 is objected to because of the following informalities: PCA should be spelled out the first time it is introduced, such as “Patient Control Analgesia (PCA)”. 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.
Claim 5 is 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.
Claim 5 recites the limitation "the soft, upper limits" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the acceptable parameter values”.
Claim 5 recites the limitation "the hard, upper limits" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the lower limits”.
Claim Rejections - 35 USC § 103
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.
Claims 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Erlen et al (Erlen) US 2023/0074811 A1 in view of Ford et al. (Ford) US 5,681,285 in view of Vik et al. (Vik) US 2012/0176394 A1.
Regarding claim 1, Erlen discloses a PCA (this is being interpreted as a mere statement of purpose or use that does not result in a structural difference between the claimed invention and prior art, MPEP 2111.02) pump (pump, P0014) comprising: an actuator (actuator, P0037); a display screen (screen, P0015); a processor (processing unit, P0022); and a memory storing instructions (memory, P0022), which when executed by the processor, cause the processor to receive a user-selected infusion therapy type (dimenhydrinate, Fig. 8) and a user-inputted parameter value (50, Fig. 8), receive the lower (soft limit range, P0080) and upper limits (hard limits, P0080) of the parameter type associated with the user-inputted parameter value and user-selected infusion therapy type (limits provided by the drug library, P0081), compare the user-inputted parameter value to the lower and upper limits of the parameter type generate a graph on the display screen (limit bar 15, P0079) that shows the lower and upper limits of the parameter type in different colors (soft limit range marked in yellow, P0080, and the hard limits are not yellow).
Erlen teaches the actuator coupled to a syringe in P0037, but does not explicitly teach a syringe holder for holding the syringe.
However, Ford teaches an infusion pump having a syringe holder (clamping devices for holding the syringe, c 8 ln 10-11).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the pump of Erlen with a syringe holder for the purpose of securing the syringe.
Erlen teaches placement of a dynamic cursor on the bar based on where the user-inputted parameter value falls within the lower and upper limits of the parameter type P0083, but does not teach generating different-colored text for the user-inputted parameter value as well.
However, Vik teaches an infusion pump P0011 generating (visual profile generator 170, P0012) different-colored text (text color, P0016) for a user-inputted parameter value (user inputs, P0015).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the user-inputted parameter value of Erlen with colored text based on where the user-inputted parameter value falls within the lower and upper limits of the parameter type for the purpose of enhancing safe use, Vik P0017.
Regarding claim 2, Erlen in view of Ford in view of Vik teaches the PCA pump of Claim 1, wherein the upper and lower limits of the parameter type include the soft limits (Erlen, soft limit range, P0080) and hard limits (Erlen, hard limits, P0080).
Regarding claim 3, Erlen in view of Ford in view of Vik teaches the PCA pump of Claim 2, wherein the graph is a bar graph (Erlen, limit bar 15 shown in Fig. 8).
Regarding claim 4, Erlen in view of Ford in view of Vik teaches the PCA pump of Claim 3, wherein the different colors in the bar graph correspond with the lower (Erlen, soft limit range marked in yellow, P0080) and upper limits (Erlen, hard limits are not yellow) of the parameter type.
Regarding claim 7, Erlen in view of Ford in view of Vik teaches the pump of Claim 1, wherein the memory stores a drug library containing drug entries with upper and lower parameter limits (Erlen, limits provided by the drug library, P0081).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Erlen in view of Ford in view of Vik as applied to claims 2 and 4 above, and further in view of Russell US 2006/0258985 A1.
Regarding claim 5, Erlen in view of Ford in view of Vik teaches the PCA pump of Claim 4.
Erlen in view of Ford in view of Vik do not explicitly teach wherein a green color corresponds with acceptable parameter values, yellow areas correspond with parameter values that exceed the soft, upper limits, and red areas correspond with parameter values that exceed the hard, upper limits.
However, Russell teaches a graphical display of medication limits wherein a green color corresponds with acceptable parameter values (green for acceptable, P0056), yellow areas correspond with parameter values that exceed the soft, upper limits (yellow for caution areas, P0056), and red areas correspond with parameter values that exceed the hard, upper limits (red for unacceptable, P0056).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the color of the user-inputted parameter value of Erlen in view Vik as taught by Russell for the purpose of aligning the significance of the user-putted parameter value with the color that signifies acceptable values which is green, potentially acceptable values which is yellow and unacceptable values which is red.
Regarding claim 6, Erlen in view of Ford in view of Vik teaches the PCA pump of Claim 2.
Erlen in view of Ford in view of Vik do not explicitly teach wherein the text is a green color if it is an acceptable parameter value, the text is a yellow color if it is within the soft limits for the parameter type, and the text is in a red color if it is within the hard limits for the parameter type.
However, Russell teaches a graphical display of medication limits wherein the text is a green color if it is an acceptable parameter value (green for acceptable, P0056), the text is a yellow color if it is within the soft limits for the parameter type (yellow for caution areas, P0056), and the text is in a red color if it is within the hard limits for the parameter type (red for unacceptable, P0056).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the color of the user-inputted parameter value of Erlen in view Vik as taught by Russell for the purpose of aligning the significance of the user-putted parameter value with the color that signifies acceptable values which is green, potentially acceptable values which is yellow and unacceptable values which is red.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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