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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 1-41 are rejected under 35 U.S.C. 103 as being unpatentable over DeAngelo et al. (US 2005/0186183) in view of Patatanyan et al. (US 2022/0106357). The claims are reasonably and broadly construed, in light of the accompanying specification, to be disclosed by DeAngelo as teaching:
a lyobead manufacturing system (see title and abstract) comprising:
a reagent fluid (paragraph [0022]) source 3 containing a fluid (paragraph [0032]);
a fluid dispense head 7 configured to dispense a plurality of spherical droplets (paragraph [0063], [0067]) of the fluid;
a fluid line 8 connecting the reagent fluid source with the fluid dispense head;
a fluid pressurizing system 10 comprising a pressure regulator configured to pressurize the reagent fluid source (the claimed pressure regulator is disclosed because gravitational force with regulate fluid pressure since higher level fluid is pressured to flow downward in a fluid source as disclosed in paragraphs [0030]-[0031]);
a liquid container 21 comprising a liquid coolant (wherein the disclosed stabilized/processed product reconstituted with an appropriate dilute/fluid in paragraph [0032] meets the liquid coolant because the platelets in paragraph [0080] are cooled such that blood is a liquid coolant); and
a motion system 2, 10 for moving the fluid dispense head in at least two dimensions relative to the liquid container while maintaining a constant height above an upper surface of the liquid coolant. DeAngelo discloses the claimed invention, except for the recited pump (disclosed in paragraphs [0063], [0065], [0067] and shown in figures 1, 2). Patatanyan, another lyobead type manufacturing system, disclosed that feature at paragraph [0165]). It would have been obvious to one skilled in the art to combine the features of DeAngelo with the features of Patatanyan for the purpose of using a motive force to move pressurized fluid through a system including a motion system. Furthermore, DeAngelo in view of Patatanyan discloses the claimed invention, except for the claim 2 fluid volume from 2 to 50 L and claim 3 chiller viscosity adjustment configuration and the claim 4 homogenize fluid means, claim 5 plural fluid lines, claims 6, 7, and 16 valve means including connections, claims 7 and 8 times, claims 9-11 and 26 droplet size and/or aperture diameter, claim 12 threaded connection, claims 12-15 pump means, pump types, and/or pressure adjustments, claim 17 nitrogen means, claims 18-25 and 27-34 shuttle means including directions, claims 35-37 dispensing means, control board, and/or method times thereof, claims 38-41 well means, nozzle height, time, and/ or coolant depth, . It would have been an obvious matter of design choice to recite those features, since the teachings of DeAngelo in view of Patatanyan would perform the invention as claimed, regardless of that feature and applicants have not claimed or specified the criticality of that feature as being necessary for patentability.
Response to Arguments
Applicant's arguments filed June 23, 2026 have been fully considered but they are not persuasive.
Rejections under 35 USC § 102
No anticipation rejection was made under so those arguments will not be addressed and are moot.
Rejections under 35 USC § 10
Examiner must give the claims a broadest reasonable construction, in light of the accompanying specification as discussed in the rejection above. Claim terms cannot be given narrower meanings and must be construed, regardless of the specification, since the specification cannot narrow a plain meaning without using those specification terms in the claim. Specification terms cannot be imported into the claims and claims are given a plane meaning.
Applicants argue that the claimed pressure regulator is disclosed in paragraphs [0030]-[0031], as rejected above, because gravity and disclosed purging is regulated by pressure in function and structure, as rejected and disclosed by DeAngelo.
Applicants further argued that DeAngelo does not disclose a liquid container, however paragraph [0032] expressly discloses this feature as discussed in the rejection above.
Also applicants argue that the claimed motion system for moving is not disclosed by DeAngelo, but as rejected paragraph [0033] meets the claimed motion system because as disclosed and rejected above, fluid is moved from a dispense head in at least two dimensions relative to a liquid container while maintaining a constant height above and upper surface of a liquid coolant.
DeAngelo teaches lyophilization freeze drying in paragraphs [0016]-[0019] contrary to applicants assertion and arguments
Secondary reference Patatanyan obviates DeAngelo is rejected above. That reference is not cited to teach all the features of DeAngelo, but rather that it would have been obvious to one skilled in the art to combine the teachings in order to obviate the claimed invention.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as discussed above it would have been obvious to one skilled in the art to combine the teachings in order to obviate the claimed invention.
In response to applicant's argument that DeAngelo or Patatanyan are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, it would have been obvious to one skilled in the art to combine the teachings in order to obviate the claimed invention.
In response to applicant's argument that lyophilization or pressure regulator, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
THIS ACTION IS MADE FINAL. 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 STEPHEN MICHAEL GRAVINI whose telephone number is (571)272-4875. The examiner can normally be reached M-Th 5:30 am to 5:00 (mid day flex) first F 6:00 am t0 11:00 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Craig Schneider can be reached at 571 272 3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN M GRAVINI/Primary Examiner, Art Unit 3753
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