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 .
Claims 1-5, 7-22 and 37-47 are pending in this application and were examined on their merits.
The objection to the Specification because it contained an embedded hyperlink and/or other form of browser-executable code has been withdrawn due to the Applicant’s amendments to the Specification filed 05/26/2026.
The objections to Claims 41, 42, 43 and 44 because of minor informalities have been withdrawn due to the Applicant’s amendments to the claims filed 05/26/2026.
The rejections of Claims 14 and 16-20 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inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, have been withdrawn due to the Applicant’s amendments to the claims filed 05/26/2026.
The rejection of Claim(s) 1-41 and 43 under 35 U.S.C. § 103 as being unpatentable over Lui et al. (US 9,545,379 B2), in view of Hubbard, JR. et al. (US 2012/0167405 A1), both cited in the IDS, has been withdrawn due to the Applicant’s amendments to the claims filed 05/26/2026.
The rejection of Claim(s) 1-41, 42, 43 and 44 under 35 U.S.C. § 103 as being
unpatentable over Lui et al. (US 9,545,379 B2), in view of Hubbard, JR. et al. (US
2012/0167405 A1), both cited in the IDS, as applied to Claims 1-41 and 43, and
further in view of Ng et al. (2015), has been withdrawn due to the Applicant’s amendments to the claims filed 05/26/2026.
The provisional rejection of Claims 1-5, 9-12, 14-18, 21 and 22 on the ground of
nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 6-9 and 10-12
of copending Application No. 18/467,074 in view of Lui et al. (US 9,545,379 B2), has been withdrawn due to the Applicant’s filing of a Terminal Disclaimer on 05/26/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: The word “said” or “the” should be inserted between “wherein” and “spray” in Line 17. Appropriate correction is required.
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.
Claims 1-5, 7-41, 43 and 45-47 are newly rejected under 35 U.S.C. § 103 as being unpatentable over Liu et al. (US 9,545,379 B2), cited in the IDS, in view of Liu et al. (2018) and Hubbard, J.R. et al. (US 2012/0167405 A1), cited in the IDS.
Liu et al. (‘379) teaches a method of producing spray dried plasma, comprising
pretreating plasma from a blood donor (Column 5, Lines 35-36) with one or more
SDSAS, wherein the SDSAS may be glycine-HCI at a concentration between about
0.001 and 0.050 mmol/mL (or about 1 to about 50 µmol/mL) of the plasma to create a
formulated plasma;
and drying the formulated plasma with a spray dryer to create spray dried
formulated plasma (Columns 24-25, Claim 1), and reading on Claims 1, steps ai, ii) and b) and 37, steps a) and b), 39, 40 and 45, steps a) and b).
With regard to Claims 1, 37 and 45, step b), Liu teaches the spray dryer head and spray drying chamber (e.g. the spray drying device) are formed from disposable materials (therefore meeting the limitation of being "disposable") (Column 14, Lines 2- 6).
With regard to Claims 1, 37 and 45, steps i) and ii), Liu teaches a spray drying head comprising a spray dry nozzle in fluid communication with the formulated plasma and a compressed/pressurized aerosol gas source wherein the pressurized aerosol gas atomizes the formulated plasma entering the drying chamber (Figs 4a-c);
a drying gas jet/inlet in communication with a drying gas source to provide drying gas to the drying chamber (Fig. 1a, #116 and 116a and Figs. 4a,b);
and a drying chamber wherein atomized plasma droplets dehydrate (e.g. remove water and produce humidity) in contact with drying gas to obtain spray dried formulated plasma (Figs. 4a,b)
With regard to Claim 1, step ii) and 47, step ii), Liu teaches the reconstitution of the spray dried formulated plasma (Columns 24-25, Claim 1);
wherein the reconstituted the spray dried formulated plasma has a recovered amount of vWf (plasma protein) that is greater compared to reconstituted spray dried plasma not treated with SDSAS (Column 26, Claim 16),
and wherein the spray dried plasma contains clotting factors important in patient treatment after trauma injuries to promote clotting of wounds (Column 6, Lines 26-33).
With regard to Claims 10 and 46, Liu teaches the formulated plasma has a pH of about 5.5 to about 6.5 (contained within the claimed pH in a range from about 6 to about 6.6) (Column 25, Claim 10).
With regard to Claims 11 and 47, Liu teaches reconstituting the spray dried formulated plasma with sterile water (e.g. reconstitution solution) (Column 25, Claim 2).
With regard to Claims 12 and 47, step ii), Liu teaches the reconstituted plasma has a pH of about 6.8 to about 7.6 (contained within the claimed range of about 6.7 to about 7.8) (Column 25, Claim 3).
With regard to Claim 13, Liu teaches the reconstituted plasma is suitable for
subjects to which it is to be administered (transfused) (Column 2, Lines 24-29).
Therefore, the ordinary artisan would have recognized that the reference has "selected"
a subject in need of plasma transfusion and it would have been obvious to perform such
a transfusion. Those of ordinary skill in the art would have been motivated to make this
modification in order to treat a subject in need of a plasma transfusion. There would
have been a reasonable expectation of success in making this modification because Liu
teaches that the reconstituted plasma is suitable for transfusion into subjects.
With regard to Claim 14, Liu teaches contacting plasma with the SDSAS
pretreatment solution prior to spray drying (Column 4, Lines 26-35) and wherein the
volume of the pre-spray dried plasma is determined and an SDSAS dose is measured
to obtain the desired pH of the plasma formulation (Column 8, Lines 52-61). One of
ordinary skill in the art would recognize that the volume of plasma, volume of
pretreatment solution and the precent difference between them are result-effective
optimizable variables. Liu's teaching of measuring the volume of plasma to be treated to determine how much SDSAS to mix with the plasma provides motivation for someone of ordinary skill in the art to practice or test the plasma and pretreatment solution volume and % difference parameter values widely to find those that are functional or optimal to produce the desired pH in the plasma formulation, which then would be inclusive or cover the instantly claimed values. Absent any teaching of criticality by the Applicant concerning the volume of plasma, pretreatment solution or the % difference thereof, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations as optimizable variables which can be met as a matter of routine optimization (see MPEP § 2144.05 (II)(B). Those of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification in order to obtain a plasma formulation with the desired pH.
With regard to Claim 15, Liu teaches the formulated plasma is subjected to shear stress (e.g. agitation) prior to spray drying (see Fig. 4a, "feeding line").
With regard to the limitations of Claims 16-20, 37, step ii), 41, 43 and 45, step ii), these would be inherent in the use of a pretreatment solution comprising an SDSAS HCI and the amino acid glycine of Liu (‘379) to pretreat a plasma sample, because the instant Specification states at Pg. 3, Paragraph [0018] that:
It has been discovered that acceptable C5a levels result from a pretreatment solution having an
SDSAS and an amino acid addition, and optionally rapid mixture/agitation of the pretreatment
components. Acceptable C5a levels are those that are similar to C5a levels NFP or an FDA approved plasma product. In an embodiment C5a levels are reduced, as compared to C5a levels from rehydrated plasma that underwent pretreatment only with a SDSAS, and optional rapid mixture/agitation of the pretreatment components. In particular, levels of C5a for reconstituted plasma resulting from the pretreatment solution of the present invention can be between about 0.1 ng/mL to about 30 ng/mL and in particular between 8 ng/mL and 12 ng/mL (e.g., about 10 ng/mL). C5a levels are reduced, as compared to plasma not subjected to a pretreatment solution having at least one SDSAS and at least one amino acid. In an embodiment, the C5a levels are reduced by about 20% or less (e.g., 20%, 15%, 10%, 5%, 1%), as compared to plasma not subjected to the pretreatment solution of the present invention. In another embodiment, C5a levels are about the same as that of never frozen plasma, or within about 20% or less (e.g., 20%, 15%, 10%, 5%, 1%) of C5a in never frozen plasma or approved FDA plasma products.
As the prior art teaches the same SDSAS acid/amino acid pretreatment solution to treat plasma as claimed, it would be expected to produce a plasma formulation with the same properties and characteristics, such as plasma proteins being about the same as in approved FDA plasma products (e.g., a corresponding clinical reference range). This is further supported by Liu et al. (2018) whom teaches a glycine-HCl pretreated, spray-dried plasma formulation comprising C5a at 9.6± 3.7 ng (which is within the ranges in Claims 16-17).
Further, the discovery of a previously unappreciated property of a prior art composition or the prior arts non-recognition of an inherent feature is not an indicial of non-obviousness. See the MPEP at 2112, I. and II.
With regard to Claims 21, 22, 37, step ii) and 38; respectively that: the one or
more plasma proteins is vWf and the amount thereof is about 5-40% or 10-35% greater
than that of reconstituted plasma not pretreated with SDSAS; and wherein an amount of plasma proteins in the reconstituted plasma is within 10% or 20% of that in plasma not subjected to step a), Liu teaches that the spray dried formulated plasma (same percentage whether reconstituted or not) has a recovery of active vWf at least 10-20% greater (overlapping the claimed ranges) than the recovery obtained from plasma not treated with SDSAS (Column 2, Lines 65-67 and Column 3, Lines 1-5).
The teachings of Liu et al. were discussed above.
Liu et al. did not teach a method wherein the pretreatment solution comprises glycine in an amount ranging from about 50-110 µmol/mL of plasma or about 50 or 100 nM;
and HCI in an amount ranging from about 10-30 µmol/mL of plasma or about 1- 50 nM, as required by Claims 1 and 37&45, step a) respectively;
wherein the molar ratio of glycine to HCl is between about 1.5 and 8, as required by Claims 1, 37 and 45, step a);
wherein the spray drying nozzle comprises a vortex generator, as required by Claims 1 and 37, step i) and Claim 45, step ia).
wherein the pretreatment solution comprises glycine in an amount ranging between about 70 µmole/mL of plasma and about 90 µmole/mL of plasma, as required by Claim 2;.
wherein the pretreatment solution comprises glycine in an amount of about 84 µmole/mL of plasma, as required by Claim 3;
wherein the pretreatment solution comprises HCl in an amount ranging between about 15 µmole/mL of plasma and about 25 µmole/mL of plasma, as required by Claim 4;
wherein the pretreatment solution comprises HCl in an amount of about 20 µmole/mL of plasma, as required by Claim 5;
wherein the molar ratio of glycine to HCl is between about 2 and 6, as required by Claim 7;
wherein the molar ratio of glycine to HCl is between about 4.15, as required by Claim 8;
wherein the pH of the pretreatment solution is in a range from about 2.0 to about 4.0, as required by Claim 9.
Hubbard, JR. et al. teaches a spray drying nozzle assembly comprising a vortex
generator wherein cyclonic separation removes the atomized particles from the air/gas
stream without the use of filters (Fig. 3a, #s 348 and 358 and 3b and Pgs. 8-9,
Paragraph [0155]).
Liu et al. (2018) teaches a method of producing spray dried plasma, comprising
pretreating plasma from a blood donor (Column 5, Lines 35-36) with glycine-HCI in a molar ratio of 3.5 (1.4:0.4) (and reading on the claimed range of between about 2 and 6 and between about 4.15) to create a formulated plasma;
and drying the formulated plasma with a spray dryer to create spray dried
formulated plasma (Pg. 708, Column 2, Lines 1-7).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of pretreating plasma with glycine-HCl prior to spray drying taught by Liu et al. (‘379) with the use of the glycine to HCl molar ratio taught by Liu et al. (2018) because Liu (‘379) is silent with regard to any particular molar ratio of glycine to HCl and Liu (2018) provides an appropriate molar ratio suitable for the same purpose. Those of ordinary skill in the art would have been motivated to make this modification in order to prepare the desired pre-treated, spray-dried plasma. There would have been a reasonable expectation of success in making this modification because both references are drawn to the same field of endeavor, that is, glycine-HCl pretreated, spray dried plasma.
It would have been further obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the spray drying head comprising a spray dry nozzle of Liu (‘379) to include a vortex generator of Hubbard because this would allow in stream separation of the atomized formulated plasma droplets without the use of filters.
Those of ordinary skill in the art would have been motivated to make this modification in order to isolate desired atomized formulated plasma droplets. There would have been a reasonable expectation of success in making this modification because both references are drawn to the same field of endeavor, that is, spray dried plasma.
While the references listed above do not specifically teach the limitation of the
amount ranges of glycine to HCI in the pretreatment solution of Claims 1, 37 and 45, step a) and 2-5 or wherein the pretreatment solution has a pH between about 2-4, as required by Claim 9; one of ordinary skill in the art would recognize that the pH and concentration/molar ratio of glycine and HCI in a pretreatment composition comprising glycine-HCI are result-effective optimizable variables. Liu et al. (‘379) teaches pretreating plasma with one or more SDSAS, wherein the SDSAS may be glycine-HCI at a concentration between about 0.001 and 0.050 mmol/mL (or about 1 to about 50 µmol/mL) of the plasma. These are endpoints in a total useful concentration range which overlaps the claimed range. The reference further teaches that SDSAS prevents or alleviates detrimental rising of pH during the spray drying process (Column 7, Lines 6-23) and that volatile strong acid (HCI) can be converted to fixed with amino acid (glycine) to render it non-volatile, making it easier to use (Column 8, Lines 4-8).
This provides motivation for someone of ordinary skill in the art to practice or test the pretreatment solution pH, individual HCI and glycine concentration and molar ratio
parameter values in a pretreatment solution widely to find those that are functional or
optimal to sufficiently prevent or alleviate detrimental rising of pH during the spray
drying process, which then would be inclusive or cover the instantly claimed values.
Claim(s) 1-5, 7-41, 42, 43, 44, 45, 46 and 47 are newly rejected under 35 U.S.C. § 103 as being unpatentable over Lui et al. (US 9,545,379 B2), cited in the IDS, in view of Hubbard, JR. et al. (US 2012/0167405 A1), cited in the IDS, and Liu et al. (2018), as applied to Claims 1-5, 7-41, 43 and 45-47 above, and further in view of Ng et al. (2015), of record.
The teachings of Liu et al. (‘379), Liu et al. (2018) and Hubbard, JR. et al. were discussed above.
The Examiner notes that Liu (‘379) discloses that vWf activity can be measured by the vWf:ristocetin cofactor assay and vWf amount can be measured by vWf antigen assay (Column 6, Lines 59-67).
None of Liu (‘379), Liu (2018) or Hubbard teach that the vWf antigen amount or vWf:ristocetin cofactor amount is between about 50-200 IU/dL, as required by Claims 42 and 44.
Ng et al. teaches that the normal range for vWf antigen amount and vWf ristocetin cofactor amount is generally between about 50-200 IU/dL (Pg. 2030, Column 2, Lines 28-29 and Pg. 2031, Column 1, Lines 10-11).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of producing spray dried plasma of Liu (‘379) so that the vWf antigen amount or vWf ristocetin cofactor amount in the reconstituted plasma is between about 50-200 IU/dL because this is the normal concentration range for these compounds. Those of ordinary skill in the art would have been motivated to make this modification in order to produce and/or use a plasma product which is as close to normal in vivo plasma as possible. There would have been a reasonable expectation of success in making this modification because Liu (‘379) produces a spray dried plasma product suitable for transfusion into a subject in need thereof and Ng teaches the normal concentrations of components found in plasma.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/26/2026, with respect to the above withdrawn objections/rejections have been fully considered and are persuasive.
The remaining arguments have been considered insofar as they apply to the pending rejections.
The Applicant argues that Hubbard does not disclose the vortex-generator nozzle configuration in the claims and the Specification. Applicant asserts that Liu does not provide evidence that the spray-dried plasma still clots (Remarks, Pg. 15, Lines 24-27 and Pg. 16, Lines 1-16).
This is not found to be persuasive for the following reasons, the claims only require a, “spray drying nozzle comprises a vortex generator” and Hubbard, JR. et al. teaches a spray drying nozzle assembly comprising a vortex generator wherein cyclonic separation removes the atomized particles from the air/gas stream without the use of filters (Fig. 3a, #s 348 and 358 and 3b and Pgs. 8-9, Paragraph [0155]). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). With regard to Applicant’s allegation that the Liu Patent does not provide evidence that the spray-dried plasma still clots, the prior art patent provides an enabling disclosure and proof of efficacy is not required. See the MPEP at 2121, I. and III. For the record, the Examiner notes that Liu (2018) does provide clotting data of glycine-HCl pretreated, spray dried plasma at Pg. 711, Table 4.
The Applicant argues that the Claims have been amended to require that the reconstituted, spray dried plasma induces clot formation a feature not taught or suggested by Liu and an alleged unexpected result (Remarks, Pg. 16, Lines 21-30 and Pg. 17, Lines 1-13).
This is not found to be persuasive as Liu (‘379) teaches the reconstitution of the spray dried formulated plasma (Columns 24-25, Claim 1); wherein the reconstituted the spray dried formulated plasma has a recovered amount of vWf (plasma protein) that is greater compared to reconstituted spray dried plasma not treated with SDSAS (Column 26, Claim 16), and wherein the spray dried plasma contains clotting factors important in patient treatment after trauma injuries to promote clotting of wounds (Column 6, Lines 26-33). Thus, the prior art composition would be expected to retain sufficient vWf clotting factor and induce clot formation which are expected results.
The Applicant argues the claimed invention requires a plasma pretreating step with glycine-HCl which has protective effects when the plasma is spray-dried. Applicant asserts the prior art does not recognize the beneficial effects of the pretreatment (Remarks, Pg. 17, Lines 14-32 and Pg. 18, Lines 1-5).
This is not found to be persuasive for the following reasons, the prior art makes obvious the same plasma pre-treatment prior to spray drying as set forth above. In response to Applicant's argument that the claimed invention has beneficial effects on the plasma during spray drying, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
The Applicant argues that the nozzle of Hubbard is not a nozzle vortex generator as claimed which atomizes the treated plasma but a cyclone precipitator designed to collect and remove dried plasma particles (Remarks, Pg. 18, Lines 6-25).
This is not found to be persuasive for the following reasons, the claims only require that “the spray drying nozzle comprises a vortex generator”. Hubbard depicts a spray drying apparatus at Fig. 3a wherein the nozzle (348) is connected to (thus comprises) the vortex generator/cyclone chamber. Thus, the prior art meets the claimed limitations.
The Applicant argues, citing the Specification and Figures, that the claimed nozzle has certain characteristics and features different from the nozzle of Hubbard
(Remarks, Pg. 18, Lines 26-30 and Pg. 19 and Pg. 20, Lines 1-8).
This is not found to be persuasive for the following reasons, the claims only require that “the spray drying nozzle comprises a vortex generator”. Hubbard depicts a spray drying apparatus at Fig. 3a wherein the nozzle (348) is connected to (thus comprises) the vortex generator/cyclone chamber. Thus, the prior art meets the claimed limitations. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant argues that the combination of Liu and Hubbard does not teach the claimed vortex-generator nozzle, the claimed pre-treatment step or the characteristics of the resulting plasma (Remarks, Pg. 20, Lines 9-18).
This is not found to be persuasive for the following reasons, as discussed in the Responses and new rejections above, Hubbard depicts a spray drying apparatus at Fig. 3a wherein the nozzle (348) is connected to (thus comprises) the vortex generator/cyclone chamber. Thus, the prior art meets the claimed limitations. Liu (‘379) in view of Liu (2018) teach the claimed molar ratio of glycine to HCl, Liu (‘379) teaches the spray dried plasma contains clotting factors important in patient treatment after trauma injuries to promote clotting of wounds (thus induces clotting) and the reduced C5a in the reconstituted spray-dried plasma of Liu (‘379) would have been inherent.
The Applicant argues that the claims also in addition to the molar ratio, the reconstituted plasma induce clot formation and that one or more plasma proteins are present in a corresponding clinical range. Applicant notes that Ng does not remedy these deficiencies (Remarks, Pg. 20, Lines 19-30 and Pg. 21, Lines 1-7).
This is not found to be persuasive for the following reasons, as discussed in the new rejections above, Liu (‘379) in view of Liu (2018) teach the claimed molar ratio of glycine to HCl, Liu (‘379) teaches the spray dried plasma contains clotting factors important in patient treatment after trauma injuries to promote clotting of wounds (thus induces clotting) and as the prior art teaches the same acid/amino acid pretreatment solution to treat plasma as claimed, it would be expected to produce a plasma formulation with the same properties and characteristics, such as plasma proteins being about the same as in approved FDA plasma products (e.g., a corresponding clinical reference range). This is further supported by Liu et al. (2018) whom teaches a glycine-HCl pretreated, spray-dried plasma formulation comprising C5a at 9.6± 3.7 ng (which is within the claimed ranges). The Examiner notes that Ng was cited only for its’ teaching of the normal range for vWf antigen amount and ristocetin cofactor amount.
The Applicant argues that the cited prior art does not teach or suggest the limitations of New Claims 46-47 (Remarks, Pg. 21, Lines 8-13).
This is not found to be persuasive for the reasoning provided in the above new rejections.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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