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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED NON-FINAL ACTION
This is the initial Office Action (OA), on the merits, based on the 18/386,623 application filed on November 3, 2023. Claims 21-40 are pending. Claims 21-30 are examined, on the merits, in this Office action. The examined claims are directed to an apparatus.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 21-30, in the reply filed on October 29, 2025 is acknowledged. Claims 31-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The Examiner has considered the information disclosure statements (IDS) submitted on 12/04/2023. Please refer to the signed copy of the PTO-1449 form attached herewith.
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 21-30 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 pre-AIA the applicant regards as the invention.
Claim 21 is directed to an apparatus but has procedure steps due to the nature and structure of the programmed controller. However, in view of Applicant’s specification the claim could be unclear to one of ordinary skill in the art due to the manner in which claim 21 recites the controller’s outlined procedure, or the intended steps related to the controller or its capability. For example, if the controller is indeed performing a procedure, gerund language is generally preferred for clarity purposes for the controller’s programmed actions that are tantamount to potential manipulative steps, even if not strictly required.
Additionally, since the controller controls the pump assembly on different occasions, such as to convey blood to a separator, to convey first and second portions of the plasma out of the separator, and to convey first, second, third and fourth portions of the red blood cells out of the separator, it is unclear from the recitation how the controller distinguishes the various pump assembly actions, and the different portions of plasma and red blood cells, without related recited structure for accomplishing the noted actions. That is, the various ‘controls’ language such as ‘controls the pump assembly to convey blood into a separator mounted to the blood separator mounting station and drive unit,’ is functional since such language recites either a manner of operating an apparatus, a material that the apparatus works upon, or the result of a previously claimed structure rather than clearly imposing any additional structure. The boundaries of such functional language is unclear since the claim does not always provide a discernible boundary regarding what structures provide each of the functional characteristics.
For example, claim 21 does not recite sources or conveying mechanisms for the blood, additive fluid, or air, so it is unclear how the pump assembly or controller will access and convey these constituents. It’s also unclear why there is no third and fourth portion of plasma to correspond to the third and fourth portions of red blood cells.
In summary, the claims do not describe the interaction of the various existing components in a way that imparts sufficient structure and clarity. Since claims 21 – 30 are apparatus claims, Examiner suggests that Applicant amend the claims to more clearly specify how the claimed structures accomplish the recited functions, provided such an amendment is supported by the original specification. MPEP §§2173.02, 2173.05(g).
It is not enough for an Applicant to state or to later argue that persons of ordinary skill in the art would know what structures to use to accomplish the claimed function. Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1380 (Fed. Cir. 1999). The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing that structure. Biomedino, LLC v. Waters Technologies Corp., 490 F.3d 946, 953 (Fed. Cir. 2007).
Claims 22-30 depend on claim 21.
Conclusion
There are no prior art related rejections in this OA.
Examiner recommends that for any substantive claim amendments made in response to this Office Action, or to otherwise advance prosecution, or for any remarks concerning support for added subject matter or claim priority, that Applicant include either a pinpoint citation to the original Specification (i.e. page and/or paragraph and/or line number and/or figure number) to indicate where Applicant is drawing support for such amendment or remarks, or a clear explanation indicating why the particular limitation is implicit or inherent to the original disclosure.
Electronic Inquiries
Any inquiry concerning this communication or an earlier communications from the examiner should be directed to Hayden Brewster whose telephone number is (571) 270-1065. The examiner can normally be reached M-Th 9 AM - 4 PM.
Alternatively, to contact the examiner, Applicant may send a communication, via e-mail or fax. Examiner’s direct fax number is: (571) 270-2065. Examiner's official e-mail address is: "Hayden.Brewster@uspto.gov." However, since e-mail communication may not be secure, Examiner will not respond to a substantive e-mail unless Applicant’s communication is in accordance with the provisions of MPEP §502.03 & related sections that discuss the required Authorization for Internet Communication (AIC). Nonetheless, all substantive communications will be made of record in Applicant’s file.
To facilitate the Internet communication authorization process, Applicant may file an appropriate letter, or may complete the USPTO SB439 fillable form available at https://www.uspto.gov/sites/default/files/documents/sb0439.pdf, preferably in advance of any substantive e-mail communication. Since one may use an electronic signature with this particular form, Applicant is encouraged to file this form via the Office’s system for electronic filing of patent correspondence (i.e., the electronic filing system (Patent Center)). Otherwise, a handwritten signature is required. In addition to Patent Center, Applicant can submit their Internet authorization request via US Postal Service, USPTO Customer Service Window, or Central Fax. Examiner can also provide a one-time oral authorization, but this will only apply to video conferencing. It is improper to request Internet Authorization via e-mail.
Examiner interviews are available via telephone, in-person, and via 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) form available at http://www.uspto.gov/interviewpractice, or Applicant may call Examiner, if preferable. Applicant can access a general list of patent application forms at either https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012 (applications filed on or after September 16, 2012) or https://www.uspto.gov/patent/forms/forms (applications filed before September 16, 2012). Note that the language in an AIR form is not a substitute for the requirements of an AIC, where appropriate. The mere filing of an Applicant Initiated Interview Request Form (PTOL-413A) or a Letter Requesting Interview with Examiner, in EFS-Web, may not apprise Examiner of such a request in a timely manner.
If attempts to reach the Examiner are unsuccessful, Applicant may reach Examiner’s supervisor, Bobby Ramdhanie at 571-270-3240. The central fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAYDEN BREWSTER/Examiner, AU 1779