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’s) submitted on 09/09/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claims 16 and 18 are objected to because of the following informalities:
Claim 16 recites the term “HL7”, the abbreviation needs to be defined in the claim.
Claim 18 recites “Herewirhpharmacy preparation system”. This appears to be a typographical error, and needs to be corrected.
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:
"pharmacy preparation system", in claims 1 and 18,
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Claims 1 and 18: Paragraph 00168 of the Specification discloses the "pharmacy preparation system" may include any system that is configured to manage and prepare compound solutions (e.g., TPN solutions and other multi-ingredient solutions) for administration to a patient. For example, the pharmacy preparation system 420 may include the Baxter® EXACTAMIX™ Compounder, which is an automated pumping system that compounds multiple sterile ingredients into a finished solution in one or more patient bags.
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 § 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.
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(s) 1, 6, 14, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2016/0058673 to “Francis”, in view of U.S. Patent Application Publication No. 2017/0055926 to “Takahashi”, and further in view of Non-Patent Literature: “Impact of Early Parenteral Nutrition on Muscle and Adipose Tissue Compartments During Critical Illness”, to Casaer et al. “Casaer”.
Regarding claim 1 and 18, Francis discloses a pharmacy preparation system (system for monitoring a patient’s nutrition administration, Abstract) communicatively coupled to a server (enteral facility server, Paragraphs 0101, 0105, Fig. 1A, Ref. 104), the pharmacy preparation system and method (Abstract) configured to:
receive from the server, diagnostic testing results (“control signals can be generated by processor assembly to control operation of the pump”, Paragraph 0068; “once a nutritional adjustment is determined… the nutritional adjustment can be made immediately when a determination is made, which can be in real-time or near real-time, or the nutritional adjustment can be scheduled”, Paragraph 0141; wherein the nutritional adjustment is based on the generated indicator that indicates based on the diagnostic testing result, Paragraph 0163), determine a dosing regimen as a total volume of a nutrition solution to be infused per a time period based on the soft tissue peak and at least one of a gender, a height, or an ideal body weight of the patient;
determine a base dosing regimen as a total volume of a nutrition solution to be infused per a time period (determining daily caloric goal per kilogram per day, Paragraph 0118) based on at least a gender, a height, and an ideal body weight of the patient (nutritional goals based on patients heigh and weight, Paragraph 0118; wherein weight can be ideal body weight, Paragraph 0117; the nutritional goals/predicted nutritional requirements can be determined also on demographic information, Paragraph 0144, such as gender, Paragraph 0115; wherein the nutritional goals are used to determine the administration rate described in terms of volume or nutrient amount per a time interval, such as calories per day, Paragraph 0119, which would read on a base dosing regimen) and the diagnostic testing results (A recommendation can be for a formula or formula parameter due to a change in patient status, or to compensate for a detected or predicted deficit or surplus”, Paragraph 0188, such as a recommended dosing regimen “increased amount of 77 cc/hr for 18 hours out a 24 hour day, and 67 cc/hr for the remaining 6 hours of the 24 hour day”, Paragraph 0191; medical diagnostic test results, can be used to determine how and when to compensate for a deficit in nutritional administration. Such test results can be used to determine whether to change the cumulative or incremental surplus and/or deficit thresholds),
determine administration parameters for a parenteral nutrition pump based on the dosing regimen (recommending dosing regimen “increased amount of 77 cc/hr for 18 hours out a 24 hour day, and 67 cc/hr for the remaining 6 hours of the 24 hour day”, Paragraph 0191); and
transmit an administration message to the parenteral nutrition pump to cause a nutritional therapy to be administered to the patient according to the administration parameters (“control signals can be generated by processor assembly to control operation of the pump”, Paragraph 0068; “once a nutritional adjustment is determined… the nutritional adjustment can be made immediately when a determination is made, which can be in real-time or near real-time, or the nutritional adjustment can be scheduled”, Paragraph 0141) [Examiner notes that it is inherent that once a nutritional adjustment, such as administration rate for parenteral feeding (Paragraph 0142) is determined, the processor has to transmit an administration message to the pump, in order for the adjustment to be real-time or near real-time].
However, Francis does not disclose wherein the medical diagnostic testing is computed tomography, and configured to receive an information of a mid-section of a patient specifying radiodensity data of tissue.
Takahashi teaches a soft tissue analysis server (workstation such as operator workstation, Fig. 1B, Ref. 116, or networked workstation, Fig. 1B, Ref. 142, that includes a processor, such as processor 122 of Fig. 1, to quantify muscle and fat from abdominal image data, Paragraph 0008, 0042, 0046) communicatively coupled to a computed tomography ("CT") imaging device (See Fig. 1B, operator workstation or networked workstation being communicatively couple to a communication system, Ref. 128, that is coupled to the data acquisition system, Ref. 130, which is coupled to the components of the CT imaging device such as the X-ray detector elements, Ref. 110) and configured to receive a two-dimensional image of a mid-section of a patient (“receive the abdominal image data from a CT imaging system.”, Abstract; “the user may select an appropriate CT series that contains multiple CT Dicom images displayed in the axial and sagittal plane. The user selects an appropriate CT image at a desired level (e.g., third lumbar spine level (L3)”, Paragraph 0029, and abdominal CT images, Paragraph 0029, wherein the images are 2D, see Fig. 3, and Paragraph 0030) specifying radiodensity data of tissue (wherein after selection, determining subcutaneous fat, values from -200 to -30 HU are used, Paragraph 0031, while values from -30 to 200 HU are used for muscle, Paragraph 0032).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Francis's invention wherein the medical diagnostic testing is computed tomography, and configured to receive information of a mid-section of a patient specifying radiodensity data of tissue, as taught by Takahashi, in order to be able to quantify muscle and fat from a region of the body (Takahashi, Abstract), which has been shown to be useful as a biomarker to predict medical outcomes, and detect wasting syndrome that shorten survival (Takahashi, Paragraph 0004).
However, the modifications of Francis and Takahashi does not disclose the received information is indicative of a soft tissue peak that corresponds to a local peak in the range of -50 Hounsfield Units ("HU") and 80 HU.
Casaer teaches receiving CT images (Page 2301, left column, Image Computer Analysis) and using Matlab and Statview to create a distribution plot of the tissue surface area for each radiodensity value in Hounsfield Units (HU) (See Fig. 1 and caption, Histogram corresponding to Muscle) where the attenuation in HU is plotted with the number of voxels representing the surface of a particular CT slice). As can be seen in Fig. 1, the histogram for muscle includes a peak between 50 and 60 HU. The region including the peak is differentiated from a region with low density muscle (0-30 HU) (See Fig. 1, histogram for muscle, differentiation of low density muscle, and distribution containing the local peak), and using broadest reasonable interpretation, this reads on locating a soft tissue peak within the distribution plot that corresponds to a local peak in the range of -50 HU and 80 HU. The differentiation between low density muscle and other muscle containing the local peak in the distribution plot of muscle aid in quantifying the change in muscle composition (Page 2306, right column). This quantification is broadly interpreted as an indication of the soft tissue peak since the instant specification discloses that the indication regards the muscle quantity and quality of a patient in relation to intramuscular adipose tissue (Specification, Paragraph 00109).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Francis and Takahashi wherein the received information is indicative of a soft tissue peak that corresponds to a local peak in the range of -50 Hounsfield Units ("HU") and 80 HU, as taught by Casaer, in order to be able to quantify muscle composition based on the proportion of low-density muscle to normal muscle, and on the difference in attenuation (Page 2306, right column).
Further, based on the combination of Francis, Takahashi, and Casaer, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Francis, Takahashi, and Caesar, wherein the indication of Francis of an abnormality is an indication of the soft tissue peak detected in the plot of Casaer, in order to identify abnormal muscle composition that is quantified by Casaer (Page 2306, right column), since Casaer teaches that the skeletal muscle quality [i.e. the amount of abnormal vs. normal muscle composition] is correlated with caloric intake from parenteral nutrition (Page 2298, right column, measurements and main results). Additionally, Takahashi also teaches that detecting abnormal muscle composition has been shown to be useful as a biomarker to predict medical outcomes (Takahashi, Paragraph 0004).
Regarding claim 6, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Takahashi teaches the CT data two-dimensional radiodensity image is of the mid-section of the patient (“receive the abdominal image data from a CT imaging system.”, Abstract; “the user may select an appropriate CT series that contains multiple CT Dicom images displayed in the axial and sagittal plane. The user selects an appropriate CT image at a desired level (e.g., third lumbar spine level (L3)”, Paragraph 0029, and abdominal CT images, Paragraph 0029, wherein the images are 2D, see Fig. 3, and Paragraph 0030), and wherein the soft tissue peak is determined from a radiodensity distribution plot determined from the radiodensity image [Casaer teaches receiving CT images (Page 2301, left column, Image Computer Analysis) and using Matlab and Statview to create a distribution plot of the tissue surface area for each radiodensity value in Hounsfield Units (HU) (See Fig. 1 and caption, Histogram corresponding to Muscle) where the attenuation in HU is plotted with the number of voxels representing the surface of a particular CT slice). As can be seen in Fig. 1, the histogram for muscle includes a peak between 50 and 60 HU. The region including the peak is differentiated from a region with low density muscle (0-30 HU) (See Fig. 1, histogram for muscle, differentiation of low density muscle, and distribution containing the local peak), and using broadest reasonable interpretation, this reads on locating a soft tissue peak within the distribution plot that corresponds to a local peak in the range of -50 HU and 80 HU. The differentiation between low density muscle and other muscle containing the local peak in the distribution plot of muscle aid in quantifying the change in muscle composition (Page 2306, right column). This quantification is broadly interpreted as an indication of the soft tissue peak since the instant specification discloses that the indication regards the muscle quantity and quality of a patient in relation to intramuscular adipose tissue (Specification, Paragraph 00109).
Regarding claim 14, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 1 above.
Francis further teaches wherein the parenteral nutrition pump (“Parenteral pump”, Fig. 1A, Ref. 124) includes a gravity-operated pump (“the pump operates using gravity to administer the formula”, Paragraph 0024).
Regarding claim 15, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 1 above.
Francis discloses wherein the administration parameters include at least one of a nutrition volume to be infused, the nutrition solution to be infused, an infusion rate, or an infusion duration (A recommendation can be for a formula or formula parameter due to a change in patient status, or to compensate for a detected or predicted deficit or surplus”, Paragraph 0188, such as a recommended dosing regimen “increased amount of 77 cc/hr for 18 hours out a 24 hour day, and 67 cc/hr for the remaining 6 hours of the 24 hour day”, Paragraph 0191).
Claim(s) 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis, in view of Takahashi, and further in view of Casaer, as modified and applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2014/0343112 to Ferrando et al. “Ferrando”.
Regarding claim 7, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 1 above.
Francis further discloses wherein the pharmacy preparation system is further configured to determine an amount of components to be added to the nutrition solution based on the soft tissue peak (adjustment to the nutrition is based on the indication, Paragraph 0141, wherein the components are various macronutrients, micronutrients, proteins, fats, carbohydrates, vitamins, minerals, and electrolytes amounts ( ex. potassium, magnesium, calcium, and phosphorous), without limitation there, Paragraph 0086).
However, the combination of Francis, Takahashi, and Casaer does not explicitly disclose wherein the components of the nutrition solution are at least one of amino acids or glucose.
Ferrando teaches an amino acids composition (Abstract), that can be administered via parenteral routes (Paragraph 0029).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Francis, Takahashi, and Casaer, wherein the components of the nutrition solution are at least one of amino acids or glucose, as taught by Ferrando, in order to improve recovery of muscle strength and function, Paragraph 0040, for patients recovering from extended bed rest that suffer for deleterious physiological effects such as muscle atrophy and other forms of deconditioning (Paragraph 0039).
Regarding claim 8, the modifications of Francis, Takahashi, Casaer, and Ferrando disclose all the features of claim 7 above.
Francis further discloses wherein the pharmacy preparation system is further configured to determine component compositions (adding supplemental nutrition, increasing vitamin intake, Paragraph 00142; recommending and generating a formula or formula parameter due to change in patient status, Paragraph 0188) to generate the determined amount of the at least one of amino acids, lipids, or glucose (nutrient formula can include fats, Paragraph 0086, which would read on lipids).
Regarding claim 9, the modifications of Francis, Takahashi, Casaer, and Ferrando disclose all the features of claim 8 above.
Ferrando further discloses wherein the component compositions include at least one of isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, arginine, histidine, alanine, glycine, proline, serine, tyrosine, or taurine (“the composition may comprise the essential amino acids histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine, and tryptophan”, Paragraph 0009).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Francis, Takahashi, and Casaer, wherein the component compositions include at least one of isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, arginine, histidine, alanine, glycine, proline, serine, tyrosine, or taurine, as taught by Ferrando, in order to improve recovery of muscle strength and function, Paragraph 0040, for patients recovering from extended bed rest that suffer for deleterious physiological effects such as muscle atrophy and other forms of deconditioning (Paragraph 0039).
Regarding claim 10, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 1 above, including determining an amount of micronutrients to be added to the nutrition solution based on the soft tissue peak.
However, the combination of Francis, Takahashi, and Casaer do not disclose the amount of micronutrients to be added is also based on gender and age of the patient.
Ferrando teaches varying the dosage of an amino acid composition delivered parenterally (Paragraph 0029) by age and sex (Paragraph 0024).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Francis, Takahashi, and Casaer, wherein the amount of micronutrients to be added is also based on gender and age of the patient, as taught by Ferrando, in order to improve recovery of muscle strength and function, Paragraph 0040.
Regarding claim 11, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 10 above.
Francis further discloses wherein the micronutrients include at least one of vitamins, trace elements, electrolytes, or dipeptides (wherein the components are various macronutrients, micronutrients, proteins, fats, carbohydrates, vitamins, minerals, and electrolytes amounts (ex. potassium, magnesium, calcium, and phosphorous), without limitation there, Paragraph 0086).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis, in view of Takahashi, and further in view of Casaer, as modified and applied to claim 1 above, and further in view of Non-Patent Literature: Cancer Cachexia in the Age of Obesity: Skeletal Muscle Depletion Is a Powerful Prognostic Factor, Independent of Body Mass Index”, to Martin et al. “Martin”.
Regarding claim 12, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 1 above.
Francis discloses wherein the pharmacy preparation system is further configured to determine the base dosing regimen after determining the nutritional therapy is to be performed before a medical procedure is to be performed for the patient (Paragraph 0139, specifically, adjusting the nutritional intake before and/or after an anticipated event to compensate for a predicted deficit or surplus before or after the event, wherein the event is a scheduled operative procedure). Francis further discloses adjusting the nutritional intake based on an indicator wherein the indicator is based on an indication of an abnormality (Paragraph 0163),
However, Francis does not disclose the abnormality is when the soft tissue peak is below a predetermined threshold.
Martin teaches a threshold value of 41 HU for underweight and normal weight men and women, and 33 Hu for overweight or obese men and women (Table 2, Skeletal muscle attenuation) wherein below the threshold value indicates a patient with low muscle attenuation and has sarcopenia (Page 1542, right column, Section: Optimal Stratification), which would read on an abnormality.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Francis, Takahashi, and Casaer, wherein the abnormality is when the soft tissue peak is below a predetermined threshold, as taught by Martin, in order to determine whether a patient has sarcopenia that is correlated with significantly lower survival rate for cancer (Page 1542, right column, Section: Optimal Stratification), and therefore it would be obvious to increase the nutrition of the patient so the patient can be above the threshold to increase survivability.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis, in view of Takahashi, and further in view of Casaer, as modified and applied to claim 1 above, and further in view of U.S. Patent Application Publication No.2004/0181314 to Zaleski et al. “Zaleski”.
Regarding claim 16, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 1 above.
However, the modifications of Francis, Takahashi, and Casaer do not disclose wherein the administration message is an HL7-compliant message.
Zaleski teaches wherein the administration message is an HL7-compliant message (0014, wherein in maintaining multiple infusion pumps, the communication is HL7 compatible; wherein the communication using HL7, includes administration communication by the pump manger application, Paragraph 0025).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Francis, Takahashi, and Casaer, wherein the administration message is an HL7-compliant message, in order to have a validated information that can be sent to different systems such as patient monitoring, and patient admission and discharge management, Paragraph 0015).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Francis, in view of Takahashi, and further in view of Casaer, as modified and applied to claim 1 above, and further in view of Non-Patent Literature: “Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study”, to Prado et al. “Prado”.
Regarding claim 17, the modifications of Francis, Takahashi, and Casaer disclose all the features of claim 1 above.
As disclosed in the claim 1 rejection above, Takahashi teaches wherein the desired level of the selected CT image is at the third lumbar spine level (e.g., third lumbar spine level (L3)”, Paragraph 0029).
However, the modifications of Francis, Takahashi, and Casaer do not explicitly disclose wherein the desired area of the patient is between a third lumbar vertebra and a fourth lumbar vertebrae.
Prado teaches wherein the desired area of the patient is between a third lumbar vertebra and a fourth lumbar vertebra (“The third lumbar vertebrae (L3) was chosen as a standard landmark and two consecutive CT images extending from L3 to the iliac crest were chosen to measure muscle cross-sectional area”, Page 630, right column; the two consecutive CT images extending from L3 to the iliac crest reads on an area between a third lumbar vertebra and a fourth lumbar vertebra).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Francis, Takahashi, and Casaer, wherein the desired area of the patient is between a third lumbar vertebra and a fourth lumbar vertebrae, as taught by Prado, in order to identify and quantify the skeletal muscle in the region, which directly relates to a whole-body muscle mass (Prado, Page 630, right column).
Allowable Subject Matter
Claims 2-5, 13, 19, and 20 are 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, and in addition, overcoming the double patenting rejections as presented below.
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 1-12, 14-5, and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of U.S. Patent No. 12,083,317. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, ‘317 discloses a pharmacy preparation system (Claim 1, Col. 51, line 1) communicatively coupled to a server, the pharmacy preparation system configured to:
receive, from the server, information indicative of a soft tissue peak for a mid-section of a patient (Col. 50, lines 61-62), the soft tissue peak corresponding to a local peak in a range of -50 Hounsfield Units (“HU”) to 80 HU (Claim 1, Col. 50, line 65-66);
determine a dosing regimen as a total volume of a nutrition solution to be infused per a time period based on the soft tissue peak and at least one of a gender, a height, or an ideal body weight of the patient (Claim 1, Col. 51, lines 4-7);
determine administration parameters for a parenteral nutrition pump based on the dosing regimen (Claim 1, Col. 51, lines 10-12); and
transmit an administration message to the parenteral nutrition pump to cause a nutritional therapy to be administered to the patient according to the administration parameters (Claim 1, Col. 51, lines 14-17).
Regarding claim 18, ‘317 discloses a parenteral nutritional preparation method (Claim 13, Col. 52, line 1), comprising:
receiving, in a pharmacy preparation system from a server, information indicative of a soft tissue peak for a mid-section of a patient, the soft tissue peak corresponding to a local peak in a range of -50 Hounsfield Units (“HU”) to 80 HU (Claim 13, Col. 52, lines 7-11);
determining, via the pharmacy preparation system, a dosing regimen as a total volume of a nutrition solution to be infused per a time period based on the soft tissue peak and at least one of a gender, a height, or an ideal body weight of the patient (Claim 13, Col. 52, lines 12-15);
determining, via the pharmacy preparation system, administration parameters for a parenteral nutrition pump based on the dosing regimen (Claim 13, Col. 52, lines 17-19); and
transmitting, from the pharmacy preparation system, an administration message to the parenteral nutrition pump to cause a nutritional therapy to be administered to the patient according to the administration parameters (Claim 13, Col. 52, lines 20-24).
The mapping of the remaining dependent claims are as follows:
Instant Application Claim number
‘317 Claim number
2
2
3
1, (Col. 51, lines 4-7)
4
3
5
10
6
1 (Col. 50, lines 61-66)
7
4
8
5
9
6
10
7
11
8
12
9
14
11
15
12
19
14
Claims 1, 13, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,623,043. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1 and 18, ‘043 discloses a system and method (Claim 1, Col. 50, line 1, and Col. 51, line 12; the method is inherent in the system of claim 1, which includes steps performed by the system) communicatively coupled to a server, the system configured to:
receive, from the server (Claim 1, Col. 51, lines 13-14), information indicative of a soft tissue peak (Col. 51, lines 8-10) for a mid-section of a patient (Col. 50, lines 59-63), the soft tissue peak corresponding to a local peak in a range of -50 Hounsfield Units (“HU”) to 80 HU (Claim 1, Col. 51, lines 8-10);
determine a dosing regimen as a total volume of a nutrition solution to be infused per a time period based on the soft tissue peak and at least one of a gender, a height, or an ideal body weight of the patient (Claim 1, Col. 51, lines 15-23).
determine administration parameters for a parenteral nutrition pump based on the dosing regimen (Claim 1, Col. 51, lines 28-30); and
transmit an administration message to the parenteral nutrition pump to cause a nutritional therapy to be administered to the patient according to the administration parameters (Claim 1, Col. 51, lines 24-25, 31-32).
Regarding claims 12 and 13, ‘043 discloses all the features of claim 1 above.
‘043 further discloses wherein pharmacy preparation system is further configured to: determine the soft tissue peak is below a predetermined threshold (claim 1, lines, 12-20); and determine the dosing regimen is to be performed before a medical procedure for the patient when the soft tissue peak is below the predetermined threshold (claim 1, lines 21-23; Claim 3); wherein the predetermined threshold includes a value between 28 HU and 50 H and corresponds to a nutritionally unhealthy patient (claim 1, lines 12-20).
Regarding claim 20, ‘043 discloses all the features of claim 18 above.
‘043 further discloses determining, via the pharmacy preparation system, the soft tissue peak is below a predetermined threshold (claim 1, lines, 12-20); and determining, via the pharmacy preparation system, the dosing regimen is to be performed before a medical procedure for the patient when the soft tissue peak is below the predetermined threshold (claim 1, lines 21-23; Claim 3), wherein the predetermined threshold includes a value between 28 HU and 50 HU and corresponds to a nutritionally unhealthy patient (claim 1, lines 12-20).
Claim 16 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,083,317 in view of U.S. Patent Application Publication No.2004/0181314 to Zaleski et al. “Zaleski”.
Regarding claim 16, ‘317 discloses all the features of claim 1 above.
However, ‘317 does not disclose wherein the administration message is an HL7-compliant message.
Zaleski teaches wherein the administration message is an HL7-compliant message (0014, wherein in maintaining multiple infusion pumps, the communication is HL7 compatible; wherein the communication using HL7, includes administration communication by the pump manger application, Paragraph 0025).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of ‘317, wherein the administration message is an HL7-compliant message, in order to have a validated information that can be sent to different systems such as patient monitoring, and patient admission and discharge management (Paragraph 0015).
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,083,317 in view of Non-Patent Literature: “Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study”, to Prado et al. “Prado”.
Regarding claim 17, ‘317 discloses all the features of claim 1 above.
However, ‘317 does not disclose wherein the mid-section of the patient is an area between a third lumbar vertebra and a fourth thoracic vertebra of the patient.
Prado teaches wherein the desired area of the patient is between a third lumbar vertebra and a fourth lumbar vertebra (“The third lumbar vertebrae (L3) was chosen as a standard landmark and two consecutive CT images extending from L3 to the iliac crest were chosen to measure muscle cross-sectional area”, Page 630, right column; the two consecutive CT images extending from L3 to the iliac crest reads on an area between a third lumbar vertebra and a fourth lumbar vertebra).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by ‘317, wherein the desired area of the patient is between a third lumbar vertebra and a fourth lumbar vertebrae, as taught by Prado, in order to identify and quantify the skeletal muscle in the region, which directly relates to a whole-body muscle mass (Prado, Page 630, right column).
Conclusion
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/MT/ Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798