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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-13 in the reply filed on 2/6/26 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 9 are is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. These claims recite an equation, but is not used in any way in the claimed invention, and thus fails to further limit the claims from which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim(s) 1-13 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Min et al (US 2019/0201916.)
Min’s fig. 9 is copied herein, which is identical to applicant’s fig. 2. Min, from [0308], page 20, to [0333], page 32, and figures 50-53, which are labelled as flow circuits 12H, are same as applicant’s flow circuits 12, figures 3-5 and 7 in applicant’s disclosure.
They include the pump system, the valve system, and the separation system including centrifugal (36) and spinning (26) separation devices with the specified functions. Min teaches the controller as configured/programmed for the operation of these systems in part V., Aspects, starting at [0398] on page 39.
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As is clearly seen in the teaching of Min, the process steps taught are substantially as disclosed and claimed by the applicant in the cited figures and paragraphs. Min is silent on selecting the first and the second target concentrations, “attempt to collect the platelet concentrate having the first target concentration” and platelet product at the second target concentration. However, the first target concentration, which is the platelet concentrate (PC) concentration, is calculated using an equation presented in claim 6, which is the equation 4 in Min cited in the “draw phase” at [0323]. Min also teaches calculating the platelet concentration similarly, using the same variables. Therefore, selecting the first target concentration and obtaining that platelet concentration is implied. Also, it would have been obvious to one of ordinary skill to confirm that the desired platelet concentration is obtained at this point. However, the selecting of the target concentrations and attempting to collect platelet concentrate and platelet product at that target concentrations are only process steps, not patentable in an apparatus claim.
Further, the claim only requires collecting PC at an actual concentration (which is at or near the first target concentration,) which is the attained concentration at the concentrate outlet of the spinning membrane separator (26.) Min clearly teaches this. Furthermore, according to applicant’s disclosure at [0088,] if the concentration of PC is different from the first target concentration, it only would adjust the additive solution to achieve the platelet product concentration to the second target concentration. That is, the controller does not control the process to achieve the first target concentration [emphasis added.]
In this regard, applicant’s disclosure states in [0010]: “One possible disadvantage of this conventional approach (which targets a desired final platelet concentration [emphasis] throughout steady state separation) is that it is vulnerable to pump-driven flow inaccuracies.” This means, configuring and operating the system to produce the desired target platelet concentration is already used by the prior arts.
Min teaches the same number and types of concentration sensors in the apparatus, and the Min teaching is the same as in the disclosure. Moreover, [0322] teaches: “On the way to the return bag F4, the plasma passes through spinner outlet sensor M2, which may cooperate with the controller 18 to determine one or more characteristics of the plasma, such as the amount of cellular blood components in the plasma…” which implies concentration based control. The second target concentration to be met is resuspended or diluted platelet concentration. Min, fig. 53 and [0333,] teaches adding platelet additive solution. The platelet product is a resuspended platelet, which is implicitly made to exacting concentrations as required for its medical uses. Therefore, the second target concentration is also implied. Or, at the least, it is obvious to one of ordinary skill in the art to dilute the platelet concentrate to the required standards.
Nonetheless, the claim only recites the controller as “configured to,” meaning, it is capable of performing the control process, unless otherwise shown. Selecting target concentrations is only a manual activity. Thus the claims are anticipated. However, as discussed above, having the target concentrations set and the computer programmed to operate the system to the target concentration would also have been routinely obvious to one of ordinary skill in the art.
Regarding the amendments to claims 1 and 8 on 6/2/26, and the arguments:
The actual concentration is understood as the platelet concentrate concentration obtained when aiming for the first target concentration.
The second target concentration is the desired final concentration of the platelet product. This is not necessarily the first target concentration.
The claimed invention dilutes the platelet concentrate from actual concentration to the second target concentration. Therefore, the first target concentration has no particular control value in the claims.
Min does not recite a first target concentration but simply determines the platelet concentrate concentration in [0323] or [0347] using the same equation as in claims 6 and 9. In the “final phase” [0333] or [0352] this concentrate is diluted to the desired concentration by adding the additive solution, and the second target concentration is therefore implied. Min also does not determine the difference between the first target concentration and the actual concentration.
Since the differences in Min actually do not make a difference in the process control configuration, and the Min control system is capable of receiving inputs for the first target concentration and determining the difference between that and the actual concentration, the claims are anticipated, or at the least made obvious by Min.
The argument that the controller somehow diagnoses [and remedies] any unusual pump operation (or the spinning membrane separator, for that matter) from the two target concentrations is not reflected in the claimed invention, nor sufficiently disclosed in the specification. What applicant does in the claims is exactly the same procedure as in Min. The platelet concentrate concentration is calculated using the equation (though not explicitly so claimed) and then an appropriate amount of additive solution is added to obtain the second target concentration. Therefore, having a first target concentration or determining the difference between the first target concentration and the actual platelet concentration do not make any difference to the process carried out in obtaining the platelet product.
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 KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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, Vickie Kim can be reached at 5712720579. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISHNAN S MENON/Primary Examiner, Art Unit 1777
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