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 Group II, corresponding to claims 12-16 in the reply filed on December 14th, 2025 is acknowledged. Claims 1-11 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In this regard, the claim limitation “means to couple” in claim 13 has been interpreted under 35 U.S.C. 112(f), because it uses a non-structural term “means” coupled with functional language “to couple all 5 stages” without reciting sufficient structure to achieve the function. Furthermore, the non-structural term is not preceded by a structural modifier.
Since this claim limitation invokes 35 U.S.C. 112(f), claim 13 is interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
However, a review of the specification does not appear to disclose the corresponding structure described in the specification for the 35 U.S.C. 112(f) limitation of “means to couple”. Therefore, said claim 13 has been rejected under 35 U.S.C. 112(b) as noted below. Appropriate action is required.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not wish to have the claim limitation treated under 35 U.S.C. 112(f), applicant may amend the claim so that it will clearly not invoke 35 U.S.C. 112(f), or present a sufficient showing that the claim recites sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f).
For more information, see Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. § 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 12-16 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.
Claim 12 recites the limitation "the SFS" in line 4. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the abbreviation of “SFS” is not a readily used term to one of ordinary skill. Thus, said term of “SFS” is vague and unclear. To obviate this rejection, it is suggested to amend to, “contact with a critical, supercritical or near critical fluid (SFS)”. Appropriate action is required.
Claim 12 recites the limitation "the incoming stream" in line 3 to line 4. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend to, “at the rate of 10 x the rate of an incoming stream”. Appropriate action is required.
Claim 12 also recites the limitation “CFI unit” in line 5. “CFI” is not a readily used term to one of ordinary skill. Thus, the term “CFI” is vague and unclear as well. It is suggested to amend to “critical fluid inactivation (CFI) unit”. Appropriate action is required.
Claim 12 recites the limitation "the recycling unit" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend to, “the recycle unit”. Appropriate action is required.
Claim 13 provides the claim limitation “means to couple”, which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 14 discloses “a biologics recycling unit” in line 1. However, a biologic recycle unit has already been recited in claim 12 (from which claim 14) depends. Thus, it is unclear if the “biologics recycling unit” claimed in claim 14 is the same recycle unit as the claimed “biologic recycle unit” claimed in claim 12, or a completely different “biologics recycling unit”. Appropriate action is required.
Claim 14 recites the limitation "the inlet stream" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend to “the incoming stream”. Appropriate action is required.
Claim 14 recites the limitation "the droplets" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 discloses “the unit” being housed in a self-contained transportable unit. However, two units are claimed in claim 12 (two-stage biologic recycle unit & three-stage CFI unit). As such, it is unclear which unit is being referenced as “the unit” in claim 16. Appropriate action is required.
Claim 15 is rejected as well merely due to their dependency from claim 12.
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.
Claims 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Monzyk et al. (U.S. Publication No. 2015/0298992).
It is first noted that the limitations disclose:
An apparatus for inactivating virus and pathogens from blood plasma and biologics;
A recycle unit for recirculating biologics to improve contact with the SFS; and
A CFI unit for processing biologics linearly.
Thus, inactivating from blood plasma and biologics is not positively recited, the recirculation (nor the SFS) is positively recited, and processing biologics linearly is not positively recited. As such, The Manual of Patent Examining Procedures specifically states that, “while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function” as well as, “a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.” (MPEP 2114). Furthermore, the limitations of “SFS” and “CFI” are vague and unclear, in which one of ordinary skill would not readily ascertain the meaning of said limitations.
With all being said, the claims will be examined accordingly.
Concerning claim 12, Monzyk discloses a five-stage apparatus (Figures 1-5 & 25-27) that is capable of inactivating virus and pathogens from human blood plasma and other biologics (paragraphs 188-193), comprising:
(a) a two-stage biologic recycle unit (Figures 1 & 8; paragraphs 152-158, 316 and 368) capable of recirculating biologics at the rate of 10 X the incoming stream to improve contact with an SFS (Figures 1 & 8); and
(b) a three-stage CFI unit (121) coupled to the output of the recycling unit capable of processing biologics linearly (paragraph 120; Figure 1).
Regarding claim 13, Monzyk also discloses means to couple all 5 stages linearly (Figures 1 & 4; paragraphs 120 & 144).
With respect to claim 14, Monzyk continues to disclose a biologics recycling unit capable of recycling the biologics back into the inlet stream to cause virions to move to the surface of the droplets for saturation by the SFS to increase levels of inactivation (Figures 1 & 8; paragraphs 152-158, 316 and 368).
Concerning claim 15, Monzyk discloses that the apparatus is configured to operate as a continuous flow unit (paragraph 158).
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Monzyk et al. (U.S. Publication No. 2015/0298992) in view of Sims et al. (U.S. Patent No. 5,328,105).
Monzyk is relied upon as set forth above. Monzyk does not appear to disclose that the unit is housed in a self-contained transportable unit. Sims discloses a five-stage apparatus for treating biologics in a fluid (Figures 1-5; column 1, lines 7-22; column 3, lines 5-25). The reference continues to disclose that the apparatus is housed in a self-contained transportable unit in order to transport the apparatus to a desired location and treat the biologics on site (column 3, lines 55-68). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to house the unit of Monzyk in a self-contained transportable unit in order to transport the apparatus to a desired location and treat the biologics on site as exemplified by Sims.
Thus, claim 16 is not patentable over Monzyk in view of Sims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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/KEVIN JOYNER/ Primary Examiner, Art Unit 1799