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 2-5, and 7-9 are cancelled.
Claims 1, 6, and 10 are pending and under examination on the merits.
Priority
Applicant’s claim of priority to CN 202210159447.8 A, filed 02/22/2022, is acknowledged. Applicant cannot rely upon the certified copy of the foreign priority application to overcome any prior art rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Withdrawn Objections/Rejections
All objections/rejections of claims 4 and 7-9 are withdrawn as moot in light of the cancellation of the claims resulting from the 02/10/2026 claim amendments. The rejections of claim 6 and 10 under 35 USC §112(b) are withdrawn as moot in light of the 02/10/2026 claim amendments removing/deleting the problematic text/recitations. The rejections under 35 USC §103 presented in the previous office action dated 11/20/2025 are withdrawn in light of the new claim scope resulting from the 02/10/2026 claim amendments.
New-Claim Interpretation
Claim 6, in accordance with its preamble, is being interpreted as a product claim (a system), such that the recited structures are required, but the gating protocol method steps are not being required/lending patentable weight.
The “analysis unit” of claim 6 is being interpreted to be Kluzaa© software (understood to refer to Kluza © software) as this is the only supported or described interpretation in the instant disclosure (see for example, paragraph 0082 at page 16 of the specification).
New-Specification
The use of the term Cytek (as in “CytekNL-3000”), which is a trade name or a mark used in commerce, has been noted in this application (see for example, paragraphs 0068 and 0080). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: Kluzaa © should be spelled Kluza ©.
Appropriate correction is required.
Claim Interpretation with respect to 35 USC §112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a flow cytometer configured to acquire fluorescence data of myeloid neoplasm cells stained with the detection reagent” and “an analysis unit configured to receive data from the flow cytometer and performing a gating protocol…” in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The "flow cytometer configured to acquire fluorescence data of myeloid neoplasm cells stained with the detection reagent" in claim 6 is interpreted as the CytekNL-3000 full spectrum flow cytometer, provided with 3 lasers (405 nanometers (nm), 488 nm and 635 nm) and 38 fluorescence detectors; a desktop low-speed centrifuge, and a vortex mixer described in paragraph 68 of the specification at page 15 and equivalents thereof.
The “analysis unit configured to receive data from the flow cytometer and performing a gating protocol…” in claim 6 is interpreted as Kluza© software as described at paragraph 0082 at page 16 of the specification, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
35 USC § 112(a)
New-New Matter
Claims 1, 6, and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The examiner is unable to find support for the added limitation in claim 1, i.e., the recited fluorophores in the newly added group. Applicant has not supplied a cited portion of the specification that would allegedly support the amendment. A review of the full disclosure does not provide support for the recited group of fluorophores. The only disclosed fluorophore combinations are disclosed in Figures 3 and 4 at pages 5-6 and 8-9, respectively of the specification. The recited fluorophores are not clearly or explicitly named in the specification. Applicant is required to cancel the new matter in response to this office action. Claims 6 and 10 incorporate, via dependency from claim 1, this new matter issue and are thus included in this rejection.
The examiner is unable to find support for the added limitation in claim 6, i.e., “a detection reagent comprising the panel of monoclonal antibodies in claim 1” (as a single reagent containing all of the recited antibodies and fluorophores). Applicant has not supplied a cited portion of the specification that would allegedly support the amendment. A review of the full disclosure does not provide support for “a detection reagent comprising the panel of monoclonal antibodies in claim 1” as the term and/or its reasonable synonyms are not used anywhere in the disclosure, there is never disclosure of a single tube flow process or a reagent comprising all of the antibodies. The closest disclosures are the discussion of Table 3, which explicitly and consistently discloses a 7-tube-8-color flow process with 4 common antibodies per tube used (see for example, pages 5-6 of the specification) and the disclosure of a 2 tube, 2 step assay wherein the first tube comprises 19 antibodies and the second tube comprises 22-24 antibodies, but does not disclose which antibodies are contained together in a single tube (see for example, paragraphs 0012-0014 at pages 7-8 of the specification). Applicant is required to cancel the new matter in response to this office action.
The examiner is unable to find support for the added limitation in claim 6, i.e., “an analysis unit”. Applicant has not supplied a cited portion of the specification that would allegedly support the amendment. A review of the full disclosure does not provide support for “an analysis unit” as the term and/or its reasonable synonyms are not used anywhere in the disclosure. Applicant is required to cancel the new matter in response to this office action.
The examiner is unable to find support for the added limitation in claims 6 and 10, i.e., “a mean fluorescence intensity (MFI)”. Applicant has not supplied a cited portion of the specification that would allegedly support the amendment. A review of the full disclosure does not provide support for “a mean fluorescence intensity (MFI)” as the term and/or its reasonable synonyms are not used anywhere in the disclosure. Applicant is required to cancel the new matter in response to this office action.
The examiner is unable to find support for the added limitation in claims 6 and 10, i.e., “a continuous distribution of CD36 fluorescence intensity ranging from a level comparable to an isotype control to a level clearly positive for CD36”. Applicant has not supplied a cited portion of the specification that would allegedly support the amendment. A review of the full disclosure does not provide support for “a continuous distribution of CD36 fluorescence intensity ranging from a level comparable to an isotype control to a level clearly positive for CD36” as the terms ‘continuous distribution’, ‘control’, ‘isotype control’, and/or “a level clearly positive for CD36) (or their reasonable synonyms) is/are not used anywhere in the disclosure, there is never disclosure of a single tube flow process or a reagent comprising all of the antibodies. Applicant is required to cancel the new matter in response to this office action.
Should applicant disagree with the examiner’s factual determination above, applicant should provide evidence that either or both of the provisional applications provide support for the invention now claimed in the manner required by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. This could be accomplished, for example, by pointing to the specific page and line numbers within the specification, which disclose each limitation of the claimed invention.
Maintained-Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6, and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B. V. v. Dianwnd Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
The Application claims a broad genus of antibodies and gating combinations thereof without disclosure of a conserved structure/representative number of species to adequately describe said genera. The Application discloses that the antibodies are commercially available (see paragraph 0063), but does not provide the individual source, clone, catalogue number or other identifier of structure of said antibodies which are effectively disclosed purely by their function of binding the recited antigens. The specification further only discloses the limited gating combinations shown in the figures at pages 1/21-21/21. Therefore, in view of this disclosure, Applicant is claiming broad genera of antibodies and gating combinations thereof without a representative number of species of said genera. The specification does not provide adequate written description for the entire claimed genera of species of antibodies or combinations thereof as claimed, because in the absence of empirical determination, one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genus claimed, specifically, which light and heavy chain CDR sequence combinations (bearing any mutations or not) might be included in the genera so as to function for immunophenotypic analysis as claimed. The CDRs and their structure are considered to be of importance because they are responsible for binding and are highly unpredictable.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Applicant has only fully disclosed that the antibodies are commercially available and has only disclosed a limited number of gating combinations. Thus, given the substantial antibody structure variation within the genus as well as the high level of unpredictability in the art, the disclosure antibodies by the antigen they bind and their generic commercial availability and the limited disclosure of gating combinations shown in the figures at pages 1/21-21/21 is not sufficiently representative of the entire genera claimed (encompassing CDRs not described or even invented and/or multiple combinations which may not have been discovered for said immunophenotypic analysis).
Furthermore, Applicant has not disclosed relevant, identifying characteristics the binding region, understood by the artisan to be formed by 6 interacting complementarity determining regions (CDRs). Applicant has not disclosed and CDR region amino acid sequences that confer upon an antibody/antibodies the ability to function as claimed in the immunophenotypic method/panel/system and/or to function as claimed in combination with the antibodies as instantly recited because the instant specification does not provide structural antibody features that correlate with a capacity to function in the claimed methods and/or combinations.
Absent a clear description of the at least minimal structural features correlating with a capacity to function as claimed which are shared by members of a genus commonly sharing this function, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish which heavy and light chain CDR amino acid sequences may be combined and used such that the resultant heavy and light chain variable regions comprise six CDRs that confer the ability to function as claimed.
Furthermore, while the prior art teaches some understanding of the structural basis of antigen-antibody recognition, it is noted that the art is characterized by a high level of unpredictability, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the antigen-binding domains. For example, Al Qaraghuli et al (2020, Nature Scientific Reports 10:13969), state that the six CDRs form a continuous surface to form the paratope that binds the epitope of the cognate antigen. This suggests that a change in the CDR sequence may result in a conformationally different paratope which may fail to bind target as claimed. Here, it is unclear what CDRs will bind an epitope allowing for use in the claimed method(s) or for combination with the other antibodies to identify/distinguish the recited cell subsets. Rabia et al (2018, Biochemical Engineering Journal 137:365-374) teach what effects mutations can have on an antibody's stability, solubility, binding affinity and binding specificity. Rabia et al report that an increase in antibody affinity can be associated with a decrease in stability (p. 366, col. 2 last paragraph; Fig. 2). Tiller et al (2017, J. Biol. Chem. (2017) 292(40) 16638–16652) and Tsuji et al (2022, J Virol 96:e00071-22) teach that mutations in the CDRs (especially HCDR3 are unpredictable and accompanied by tradeoffs in performance (for example increased affinity may lead to decreased specificity); see references in their entirety paying particular attention to the abstract of Tiller et al and the abstract and results section of Tsuji et al). The above cited references underscore the unpredictability of even a single mutation in the CDRs. The instant claims allow for any generic antibody binding the recited targets, in multiple, unsupported combinations for immunophenotypic analysis to distinguish various, vaguely defined cell subsets.
Accordingly, absent empirical determination, one skilled in the art would be unable to predict or envision which CDR sequences comprised within the genus would possess the binding traits needed to function as claimed and which antibodies may be combined such that the resultant combination possesses antigen-binding qualities capable functioning as claimed. The general knowledge and level of skill in the art does not adequately supplement the omitted description, because specific, not general guidance is needed. Since the disclosure fails to describe relevant, identifying structural characteristics, in the form of fixed heavy and light chain CDR amino acid sequence combinations, that correlate with the ability to function as claimed, and because the disclosure of commercial availability, detailed above, is not sufficient to describe the claimed genus, it is submitted that the written description requirement of 35 U.S.C. 112(a) has not been met. Further, the limited gating strategies disclosed in the figures at pages 1/21-21/21 similarly are not deemed to be representative of the breadth of gating combinations encompassed by the claims.
The claims require the use of multiple antibodies claimed by the antigen which the bind for use in an immunophenotypic method. The specification does not describe which amino acid residues of the antibody/antibodies is/are responsible for the functions claimed. Rather, the specification implies that these antibodies must first be screened to ascertain if they have the functions required by the instant claims. Although the specification provides disclosure of the antibodies purely by the antigen they bind and a statement that they are commercially available and the gating combinations shown in the figures at pages 1/21-21/21, it fails to disclose the structures common to all members of the genera of antibodies encompassed by the broad recitation provided by applicant and to provide a representative number of gating combinations. The specification does not disclose the structure(s) of all of the claimed antibodies and fails to disclose which sequences are responsible for the function(s) claimed. The specification further fails to describe which antibody structures are required to identify the related subgroups recited. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described.
Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement. Here, applicant has not described a reasonably representative number of members of the genera of antibodies and combinations thereof that would function in the method(s) as claimed, but rather has presented the public with an idea of how to perform an assay that might identify some peptides that fall within the scope of the claim. Of course, depending on what agents are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face.
In Ariad, the court further noted that the written description plays a particularly important role in the biological arts, where patentees might otherwise be tempted to claim a genus of compounds by its function or result:
“The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts. 5 See Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, 1, “Written Description” Requirement, 66 Fed. Reg. 1099, 1105-1106 (Jan. 5, 2001). This situation arose not only in Eli Lilly but again in University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 [69 USPQ2d 1886] (Fed. Cir. 2004). In Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. Id. at 918. We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification's function description, the specification did not provide an adequate written description of the claimed invention. Id. at 927-28. Such claims merely recite a description of the problem to be solved while claiming all solutions to it and, as in Eli Lilly and Ariad's claims, cover any compound later actually invented and determined to fall within the claim's functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention.”
Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). Emphasis added.
The Federal Circuit has clarified written description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AIA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of an antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional. Id.
While generically the structure of antibodies is known, the structure of the presently recited antibodies can vary substantially within the above given claimed recitations. As noted in Amgen, knowledge that an antibody binds to a particular epitope on an antigen tells one nothing at all about the structure of the antibody, wherein “instead of analogizing the antibody-antigen relationship to a ‘key in a lock,’ it [is] more apt to analogize it to a lock and ‘a ring with a million keys on it.” (Internal citations omitted). The relevant antibody art confirms this quandary, indicating that “knowledge of an epitope or antigen used to generate a monoclonal antibody is insufficient for making the original antibody available, even if suitable in vitro test systems for screening are used.” See p. 8, lines 3-5 of WO 2009/033743 A1. Therefore, those of skill in the art would not accept that the inventor had been in possession of the full genus of antibodies in the present claims.
Although screening techniques can be used to isolate CDR variant antibodies that possess the ability to function as claimed, Applicant is reminded that the written description requirement of 35 U.S.C. 112 is severable from the enablement provision. As stated in Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555, “The purpose of the 'written description' requirement is broader than to merely explain how to 'make and use'; the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.”
Therefore, the antibodies, and combinations thereof for distinguishing the recited cell subsets, as claimed are only disclosed by function/insufficient structure, without a representative number of species or unifying, conserved structure clearly enabling one skilled in the art to readily envisage the members of the genera of claimed antibodies or which gating combinations would function in the method(s) as claimed. Therefore, claims 1, 4, 6-8, and 10 are deemed to fail to meet the written description requirement, as presently drafted.
New-35 USC § 112(b)
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 6 and 10 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.
Regarding claim 6, there is no clear or closed definition of an analysis unit. The term ‘analysis unit’ is never disclosed, but the previously recited term ‘analysis moiety’ (also previously rejected for lack of clarity) is described with non-limiting examples and by vague functions. For a reading of the disclosure in its entirety, the analysis unit appears to be Kluza ©software (see the rejection under 35 USC §112(f)). Artisans are left to dispute what art-known alternatives may be encompassed or precluded (for example, would FlowJo software be considered an analysis unit encompassed by the claim?).
Regarding claim 6, MPEP § 2173.05(p) states that a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ). Therefore, since the claim encompasses a product and process of using the product, the claim is indefinite.
Regarding claims 6 and 10, there is no clear or closed definition of the recitation of “a continuous distribution of CD36 fluorescence intensity ranging from a level comparable to an isotype control to a level clearly positive for CD36”. Artisans are left to dispute whether said claimed distribution occurs on a gradient (and where the claimed boundaries of the promonocyte population may be drawn) or is a binary positive/negative distinction with respect to detected CD36 distribution, which raises the question of which interpretation is encompassed by the metes and bounds of the claim. Further, artisans are left to determine and dispute what level is “a level clearly positive for CD36” (merely positive (binary) or some undetermined/undisclosed level on a gradient of expression).
Conclusion
No claim is allowed.
Notice:
The recited antibodies and fluorophores are individually known in the art (applicant admits that the antibodies were purchased and commercially available; see for example paragraph 0063 at page 15 of the instant specification). It is noted that, for claim 1, the recited use ‘for immunophenotyping of a myeloid neoplasm,’ is an intended use which does not lend patentable weight to the claim. However, there is no art that reasonably teaches and suggested the specific, closed list of antibodies recited or which suggests that the antibodies are connected to the recited fluorophores (noting that neither the antibodies or fluorophores are part of a Markush group, but must all be present in order for the claim to be met as drafted). The closest prior art is Tsai et al (WO2019108554 A1; cited in the previous office action dated 11/20/2025). Tsai et al teach compositions such as kits and methods for immunophenotyping cells, such as myeloid neoplasms (see for example, pages 1-2, 5 [see the discussion of figures 15-18], and 47 [showing immunophenotypic analysis of chronic myeloid neoplasms]), where the antibodies used may be monoclonal (see for example, page 9 at lines 24-25). Tsai et al teach a method for hematologic tumor immunophenotyping using the following antibodies: CD10, CD11c, CD14, CD61, CD15, CD33, CD13, CD123, CD34, CD71, CD64, CD117, CD45, HLA-DR, CD4, CD16, as well as several, unrecited antibodies (see for example, the Table spanning pages 41-42 and pages 14-15 of Tsai et al). There is no reason supplied by the art to motivate removal of the additional antibodies used in the method(s) of Tsai et al and inclusion only of the other, instantly recited antibodies. There is nothing in the art guiding towards the closed antibodies recited in the panel of instant claim 1. Where the art teaches the existence and usefulness of the claimed antibodies with other, unrecited antibodies, arrival at the panel of instant claim 1 would effectively require selection from a laundry list of prior art antibodies guided by impermissible hindsight (see for example, MPEP § 2142 and §2143.01). Therefore, the panel of claim 1, and by dependency, claims 6 and 10 are deemed to be free of the art.
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.
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/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
Prosecution Insights