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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 10 Dec 2025 has been entered.
Claims 1-7 and 32-34 remain pending in the application.
Claims 1-7 and 32 are amended.
Claims 8-31 cancelled.
Claims 33 and 34 are new.
Claims 4 and 7 are withdrawn from further consideration by the examiner, pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention/species. Claim 4 requires alternative species of additives from the elected additive species.
Claims 1-3, 5, 6 and 32-34 are under consideration to the extent of the elected species, i.e. that the additive is human alpha defensins 1-3.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 Dec 2025 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Objections Withdrawn
Objections to the Specification/Drawings
The specification/Drawing objections set forth in the Non-Final Office Action mailed 11 Jun 2025 are hereby withdrawn in light of applicant’s amendments of the specification/drawings.
Rejections Maintained – In Modified Form
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.
The rejection below was previously made and is made again here with additional rejection of newly added claim 33 and to address the new limitation that the physiologic saline solution is a “human” physiologic saline solution. The examiner notes that the instant specification does not provide a limiting definition for “human physiologic saline solution” and the additional limitation of “human” is understood to merely require that the solution would be suitable for human use.
Claims 1, 2, 6, 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Flake et al. (WO 2016/205622, published 22 Dec 2016) in view of Calhoun et al. (US 6,956,023, published 18 Oct 2005) as evidenced by Biosynth (calcium chloride anhydrous | 10043-52-4 | FC30575).
Flake teaches a system configured to support growth and development of a premature fetus (abstract). Flake teaches neonatal care and in a particular aspect, improving outcomes of premature fetuses born prior to 28 weeks gestation ([0002]). Flake teaches that the extracorporeal system used includes a fluid reservoir ([0008]) and that the fetal chamber is configures to provide a fluid environment that allows fetal breathing and swallowing to support normal lung and gastrointestinal development as well as providing fluid and electrolyte balance ([0078]). Flake describes the fluid in the chamber as an “amniotic fluid” ([0093]). Flake teaches that the amniotic fluid may include primarily water mixed with a variety of elements such as electrolytes such as sodium chloride, sodium bicarbonate, potassium chloride, calcium chloride or any combination thereof dissolved in solution to mimic the ionic concentration of naturally occurring amniotic fluid for a fetus in utero ([0093]). As evidenced by Biosynth, calcium chloride is a buffering agent (page 1) and thus the inclusion of calcium chloride renders obvious the additional buffering agent of claim 6. Flake teaches an example of the amniotic fluid components comprising ionic concentrations of 109 mmol/L sodium, 100 mmol/L chlorine, 20 mmol/L bicarbonate, 6.5 mmol/L potassium and 1.6 mmol/L calcium at a pH of 7.0 ([00151]). Flake additionally teaches that the fluid may contain additional ingredients such as glucose, amino acids, lipids, essential vitamins, minerals and trace elements and that the amniotic fluid does not refer to a solution having a particular composition ([0093]). Flake teaches that the system is for a human fetus ([0079], [00116], [00143] claim 1), rendering obvious the fluids are for human use and the “human physiologic saline solution” of the instant claims.
Flake does not teach the inclusion of sodium acetate or the osmolarity. These deficiencies are made up for in the teachings of Calhoun.
Calhoun teaches materials and methods for providing nutrition to neonates (title). Calhoun teaches preventing villous atrophy by providing granulocyte colony stimulating factor (G-CSF) or erythropoietin (Epo) along with one or more electrolyte additives such as sodium chloride, sodium acetate and potassium chloride (abstract, col 2 lines 35-46). Calhoun teaches that the cessation in swallowing such trophic factors may lead to villous atrophy (col 2 lines 4-6) and Calhoun teaches providing intestinal trophic factors comparable to those they would have ingested from amniotic fluid in utero (col 2 lines 4-11) and teaches example preparations of amniotic fluid like solutions comprising sodium chloride, sodium acetate and potassium chloride (col 7 line 62-col 8 line 14). Calhoun teaches that the compositions may comprise about 50-250 mEq/L sodium chloride, about 5-50 mEq/L sodium acetate, and about 2-10 mEq/L potassium chloride (col 4 lines 55-67). The examiner notes that for the single charged ions described above that mEq/L is equivalent to mmol/L. Calhoun teaches that the consistency of the composition approximates that of natural amniotic fluid and that it can be formulated in an aqueous fluid-like form (col 7 lines 3-12).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included sodium acetate and trophic factors such as G-CSF or Epo in the amniotic fluid taught by Flake. Extracorporeal systems for neonatal care of premature human infants comprising an amniotic fluid environment comprising water and electrolytes such as sodium chloride, sodium bicarbonate, potassium chloride and calcium chloride are taught by Flake. The compositions of Flake may comprise additional components suitable for the amniotic fluid environment, as taught by Flake. It is known that infants would ingest intestinal trophic factors such as G-CSF or Epo in utero and the cessation of such trophic factors may induce villous atrophy, and that such trophic factors may be introduced as part of an aqueous amniotic fluid like composition comprising electrolyte additives such as sodium chloride, sodium acetate and potassium chloride, as taught by Calhoun. Amniotic fluid compositions comprising the electrolytes sodium chloride, sodium bicarbonate, potassium chloride and calcium chloride are known from Flake, as described above, and thus it would have been obvious to have included sodium acetate and trophic factors such as G-CSF or Epo to improve the amniotic fluid composition of Flake as the components are known with amniotic like fluids and may aid in development of neonates and preventing conditions such as villous atrophy. One would have a reasonable expectation of success in including sodium acetate as it is an electrolyte additive for amniotic like compositions that is used in conjunction with sodium chloride and potassium chloride which are the same electrolytes taught by Flake. Thus, the inclusion of sodium acetate merely represents including another electrolyte known to be part of amniotic like fluids in an amniotic fluid composition for the development of premature infants. Regarding claim 33, as noted above, it is obvious to include sodium acetate and a pH of 7.0 is obvious for the solution. The presence of the sodium acetate and the 7.0 pH is understood to render obvious the limitation that the sodium acetate is operable such that the pH of the solution is from about 7.0 to 7.4.
Regarding the specific amounts of each component as recited in claim 1, these would additionally be obvious from the teachings of Flake and Calhoun regarding the amniotic like compositions. For ease in comparison, the amounts taught by Flake and Calhoun described above are summarized in the table below.
Teachings of Flake
Teachings of Calhoun
Component
Amount
(mmol/L)
Component
Amount
(mEq/L or mmol/L)
Sodium
109
Sodium chloride
5-250
Chlorine
100
Sodium acetate
5-50
Bicarbonate
20
Potassium chloride
2-10
Potassium
6.5
Calcium
1.6
The amounts of sodium chloride, sodium acetate and potassium chloride taught by Calhoun overlap with and render obvious the claimed amounts for these components. The since sodium bicarbonate is the only source of bicarbonate taught by Flake, the 20 mmol/L of bicarbonate taught by Flake would require a concentration of 20 mmol/L of sodium bicarbonate, rendering obvious the claimed amount for this component. Similarly, the source for the 1.6 mmol/L calcium taught by Flake is derived from calcium chloride and requires 1.6 mmol/L of calcium chloride, rendering obvious this amount. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding the osmolarity of the solution from 250-270 mOsm as in claim 2, this is rendered obvious from the electrolyte concentrations described above. Osmolarity may be calculated as the sum of the molarity times the number of dissociated ions in solution
i
.
e
.
O
s
m
o
l
a
r
i
t
y
=
∑
m
o
l
a
r
i
t
y
*
n
i
. The concentrations for each component rendered obvious, as described above, is shown in the table below with the corresponding osmolarity and total osmolarity.
Component
Molarity (mmol/L)
ni
Osmolarity (mOsm)
Sodium chloride
5-250
2
10-500
Sodium acetate
5-50
2
10-100
Potassium chloride
2-10
2
4-20
Calcium chloride
1.6
3
4.8
sodium bicarbonate
20
2
40
Total
68.8-664.8
Thus, the range of osmolarity taught from Flake and Calhoun is 68.8-664.8 mOsm which overlaps with and renders obvious the instant range of 250-270 mOsm.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 10 Dec 2025 have been fully considered but they are not persuasive. Applicant states that the fluid composition taught by Flake and referenced in the rejection for the amounts is directed to a fetal sheep amniotic fluid whereas Calhoun is directed to a human amniotic fluid and it wouldn’t be obvious to combine the solution of Flake with Calhoun with a reasonable expectation of success (pages 10-11 of remarks). The examiner disagrees with this and maintains that the claimed formulation would be obvious based on the teachings of Flake and Calhoun. Flake teaches systems for supporting growth and development of premature fetus’s (abstract) and that the systems may be for either both a human or non-human fetus ([0079]). In particular Flake teaches that the fetus may be any animal including mammals such as humans ([00143]). Flake teaches the inclusion of electrolytes such as sodium chloride, sodium bicarbonate, potassium chloride, calcium chloride broadly without limiting them to either a human or non-human mammal ([0092]) and these are understood to be general components suitable for amniotic type fluids. While the solution with particular amounts taught by Flake is referred to as a fetal sheep amniotic fluid ([00151]), the salt components are all the same general salts taught by Flake and weren’t limited to a particular species. With this understanding of the teachings of Flake and the general applicability of the common salts, the combination with the teachings of Calhoun is understood as reasonable and obvious. As noted, Calhoun teaches that the compositions may comprise about 50-250 mEq/L sodium chloride, about 5-50 mEq/L sodium acetate, and about 2-10 mEq/L potassium chloride (col 4 lines 55-67). Sodium chloride and potassium chloride are the same salts taught by Flake. As Flake teaches the systems for human fetuses, and teaches the various general salts as appropriate for the solutions of the invention, it thus is reasonable to use the salts taught by Flake (i.e. sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate) and to combine these with an additional salt, sodium acetate, specifically known to be used with human amniotic fluids. The combination of potassium chloride, calcium chloride, sodium bicarbonate, sodium chloride and sodium acetate thus merely represent the combination of general salts known to be used in amniotic type fluids.
With this understanding of the obviousness of combining these salts together in an amniotic fluid, the specific concentrations are additionally obvious with the teachings take together. Flake teaches an amniotic fluid (listed as a fetal sheep amniotic fluid) and recites concentrations of the specific ions. Calhoun teaches a human amniotic fluid and recites concentrations of the salt forms. The table used in the rejection is reproduced here for clarity.
Teachings of Flake
Teachings of Calhoun
Component
Amount
(mmol/L)
Component
Amount
(mEq/L or mmol/L)
Sodium
109
Sodium chloride
5-250
Chlorine
100
Sodium acetate
5-50
Bicarbonate
20
Potassium chloride
2-10
Potassium
6.5
Calcium
1.6
When the amounts from the fluids are examined together, it is apparent that the ion concentrations from Flake fall directly within the ranges for the salts taught by Calhoun. For example, the range of sodium chloride and sodium acetate taught by Calhoun would lead to a range of sodium ion from 10-300 mmol/L and Flake teaches sodium at 109 mmol/L. Similarly, the range of sodium chloride and potassium chloride taught by Calhoun lead to a range of chlorine ion from 7-260 mmol/L and potassium from 2-10 mmol/L where Flake teaches chlorine at 100 mmol/L and potassium at 6.5 mmol/L. From this teaching it is obvious that the amniotic fluid formulations have ranges that are acceptable and are not limited to a set value and the amounts of the fetal sheep amniotic fluid taught by Flake fall directly within the ranges taught by Calhoun, leading one of ordinary skill to reasonably assume a level of compatibility with the solutions. This is understandable as sheep and humans are both mammalian species and the solutions are being constructed with common salts. The ranges for the sodium chloride, sodium acetate, and potassium chloride taught by Calhoun overlap with and render obvious the same components of the instant claims. As was noted previously, it is further obvious from the teachings of Flake to include calcium chloride and sodium bicarbonate solutions in amniotic fluids in general, including human amniotic fluids. Based on the high degree of similarity and overlap in the amounts of the other components between Flake and Calhoun, as noted above, one of ordinary skill would have a reasonable expectation of success in using the bicarbonate and calcium ion concentrations as starting points in constructing the combined solution that is obvious over Flake and Calhoun. The 20 mmol/L of bicarbonate would require and thus render obvious 20 mmol/L of sodium bicarbonate and the 1.6 mmol/L calcium would require and thus render obvious 1.6 mmol/L calcium chloride, as sodium bicarbonate and calcium chloride are the salt forms taught by Flake. Thus, based on the high degree of similarity between the teachings of Flake and of Calhoun and the similarity in the amounts taught by both references, as discussed above, the examiner maintains that the instantly claimed amounts are obvious.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Flake et al. (WO 2016/205622, published 22 Dec 2016) in view of Calhoun et al. (US 6,956,023, published 18 Oct 2005) as evidenced by Biosynth (calcium chloride anhydrous | 10043-52-4 | FC30575) as applied to claims 1, 2, 6, 32 and 33 above, and further in view of Escribese et al. (Reproductive Biology and Endocrinology 2011, 9:118).
The teachings of Flake and Calhoun are described supra.
Flake and Calhoun do not teach the inclusion of human alpha defensins 1-3. This deficiency is made up for in the teachings of Escribese.
Escribese teaches that defensins are a family of cationic antimicrobial peptides that demonstrate a broad-spectrum of microbicidal activity against bacteria, fungi and viruses and that human defensins included alpha defensins (page 1 left column). Escribese teaches that alpha defensins 1-3 are secreted by monocytes, monocyte-derived DCs, NK cells and gamma-ST cells in addition to neutrophils and that alpha-defensins 1-3 have been detected throughout the female reproductive tract and in amniotic fluids (page 1 right column).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have further included human alpha defensins 1-3 in the fluid composition rendered obvious from Flake and Calhoun. Defensins are antimicrobials with broad microbicidal activity and are known to be present in amniotic fluids, as taught by Escribese. The fluid composition of Flake and Calhoun is for treatment of neonates and resembles amniotic fluid and may contain additional ingredients, as taught by Flake. Thus, it would have been obvious to have included human alpha defensins 1-3 in the fluid composition for its antimicrobial properties and one would have a reasonable expectation of success as the alpha defensins are known to be part of amniotic fluid.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
New Grounds of Rejections
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 33 and 34 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 33 and 34 recite the phrase “a pH-modifying substance operable such that.” This phrase renders the claims indefinite as it is unclear what is fully intended by “operable such that” and how this modifying the sodium acetate and the hydrochloric acid. For example, it is not clear if this merely denotes that the components are present in the solution or if “operable such that” is intended to imply some sort of manipulation done to the component prior to inclusion in the solution.
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.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Flake et al. (WO 2016/205622, published 22 Dec 2016) in view of Calhoun et al. (US 6,956,023, published 18 Oct 2005) as evidenced by Biosynth (calcium chloride anhydrous | 10043-52-4 | FC30575) as applied to claims 1, 2, 6, 32 and 33 above, and further in view of Kabayama et al. (US 2008/0038372, published 14 Feb 2008).
The teachings of Flake and Calhoun are described supra.
Flake and Calhoun do not teach including hydrochloric acid. This deficiency is made up for in the teachings of Kabayama.
Kabayama teaches artificial physiological salt solutions ([0001]). Kabayama particularly teaches artificial amniotic fluids ([0010], [0027], [0061]) and that it is preferable to keep such fluids at a pH of 4.0 to 7.6 or 7.1 to 7.6 ([0034]). Kabayama teaches that the pH can be adjusted by adding hydrochloric acid ([0068]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included hydrochloric acid in the amniotic fluid rendered obvious over Flake and Calhoun as a means of controlling the pH of the solution. It is obvious from Flake and Kabayama to control the pH of amniotic fluids and it is known from Kabayama that hydrochloric acid is a suitable component for adjusting the pH of such solutions. Thus, it would have been obvious to include hydrochloric acid as a means of adjusting the pH of the solution and one would have a reasonable expectation of success as this is a known pH adjuster for artificial physiological salt solutions.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
The double patenting rejection below was made previously and is made again below and is updated to account for the new claims 33 and 34.
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 1-3, 5, 6 and 32-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9 and 10 of copending Application No. 18/330,548 in view of Flake et al. (WO 2016/205622, published 22 Dec 2016), Calhoun et al. (US 6,956,023, published 18 Oct 2005), Escribese et al. (Reproductive Biology and Endocrinology 2011, 9:118) and Kabayama et al. (US 2008/0038372, published 14 Feb 2008) and as evidenced by Biosynth (calcium chloride anhydrous | 10043-52-4 | FC30575) .
The ’548 application recites a sterile liquid for submergina preterm infant in an incubation chamber, the liquid comprising bicarbonate and at least one ion selected from sodium, chlorine, potassium and calcium and water and the liquid has a pH of 7.0-7.1 and is UV treated and filtered. Claims 2-10 recite additional components and filtering steps.
The ’548 application does not recite calcium chloride, potassium chloride, sodium bicarbonate, sodium chloride and sodium acetate in the amounts of instant claims 1 and 32, the osmolarity of claim 2, the alpha defensins 1-3 of claims 3 and 5 and the buffering agent of claim 6 or hydrochloric acid of claim 34. These deficiencies are made up for in the teachings of Flake, Calhoun, Escribese and Kabayama.
The teachings of Flake, Calhoun, Escribese and Kabayam are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the sterile liquid of the ‘548 application with calcium chloride, potassium chloride, sodium bicarbonate, sodium chloride and sodium acetate in amounts that render obvious the amounts of instant claim 1 and the osmolarity of claim 2 and to further include human alpha defensins 1-3 and hydrochloric acid. Extracorporeal systems for treating premature infants with amniotic fluid compositions comprising calcium chloride, potassium chloride, sodium bicarbonate, sodium chloride are known by Flake and sodium acetate is similarly known as a suitable electrolyte for amniotic type fluids from the teachings of Calhoun. The ‘548 application recites the liquid is for submerging preterm infants in an incubation chamber and comprises the same ions of bicarbonate, sodium, chlorine, potassium and calcium. Thus the liquids of the ‘548 application comprise similar components with a similar purpose as those of Flake and Calhoun and thus it would be obvious to use the specific compounds listed above as they are known for the same purpose. From the teachings of Flake and Calhoun it is obvious to have the components at the concentrations shown in the table below as they are taught by Flake and Calhoun for the compositions and which overlap with and render obvious the instant concentrations. The osmolarity from these components renders obvious the instant osmolarity as shown in the table below. The addition of the calcium chloride renders obvious the buffering agent of claim 6 as calcium chloride is a known buffering agent as evidenced by Biosynth.
Component
Molarity (mmol/L)
ni
Osmolarity (mOsm)
Sodium chloride
5-250
2
10-500
Sodium acetate
5-50
2
10-100
Potassium chloride
2-10
2
4-20
Calcium chloride
1.6
3
4.8
sodium bicarbonate
20
2
40
Total
68.8-664.8
It further would be obvious to include the human alpha defensins 1-3 in the composition as for its antimicrobial properties, as taught by Escribese. There would be a reasonable expectation of success from including the defensins as they are known to be found in amniotic fluid, as taught by Escribese. Additionally, it would have been obvious to include hydrochloric acid as a means of adjusting the pH of the solution and one would have a reasonable expectation of success as this is a known pH adjuster for artificial physiological salt solutions, as taught by Kabayama.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 10 Dec 2025 have been fully considered but they are not persuasive. Applicant states that the rejection should be held in abeyance until allowable subject matter is identified in the present application (page 12 of remarks). The examiner notes that a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600