DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 1, 3-4 and 6-11 are pending. Claims 1, 3 and 7-8 have been amended. Claims 4-6, 9-11 are withdrawn. Claims 2 and 11-16 have been cancelled.
Claims 1, 3, and 7-8 are under examination.
Withdrawn Claim Objections and/or Rejections
The arguments filed on 02/07/2025 have been considered by the examiner.
The rejection of claims 1-3, 7-8, and 12-13 under 35 USC 112(b) for being indefinite as set forth on pp. 6-8 of the previous office action (mailed on 11/07/2024) has been withdrawn in view of the amendments (filed on 02/07/2025) and in view of the cancelled claims.
The rejection of claim 3 under 35 USC 103 (a) as being unpatentable over Van Dongen in view of Flor Cytometry (FACS) Secondary Antibodies as set forth on pp. 10-11 of the previous office action (mailed on 11/07/2024) has been withdrawn in view of the amended claims (filed on 02/07/2025).
The rejections of claims 1-2, 7-8, and 12-13 under 35 USC 103(a) as being unpatentable over Wu et al., as evidenced by Anti-CD4 BD Biosciences Car No 341654, Anti-CD8 BD Biosciences Car No 558207, and Anti-CD28 BD Biosciences Cat No 555729, as set forth on pp. 11-12 of the previous office action (mailed on 11/07/2025) has been withdrawn in view of the amendments (filed on 02/07/2025) and the cancelled claims.
The rejection of claim 7 under 35 USC 103(a) as being unpatentable over Van Dongen, Anti-CD8 BD Biosciences Car No 558207, Anti-CD28 BD Biosciences Car No 555729, as evidenced by Wu et al., as set forth on pp. 12-13 of the previous office action (mailed on 11/07/2024) has been withdrawn in view of the amended claims (filed on 02/07/2025).
The rejection of claim 3 under 35 USC 103(a) as being unpatentable over Wu et al., in view of Flow Cytometry (FACS) Secondary Antibody as set forth on pp. 13-14 of the previous office action mailed on 11/07/2024) has been withdrawn in view of the amended claims (filed on 02/07/2025).
The rejection of 1-2, 7-8, and 12-13 for obvious double patenting over claims 1-2 of US 11,639,935 as set forth on pp. 14-15 of the previous office action (mailed on 11/07/2025) has been withdrawn in view of the amendments (filed on 02/07/2025) and the cancelled claims.
The rejection of claim 3 for obvious double patenting over claims 1-2 of US 11,639,935 in view of Van Dongen, and in view of Flow Cytometry (FACS) Secondary Antibody as set forth on p. 15 of the previous office action (mailed on 11/07/2025) has been withdrawn in view of the amendments (filed on 02/07/2025).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., product of nature) without significantly more. An analysis with respect to the claims as a whole reveals that they do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1
Claim 1 is directed towards naturally occurring products.
Step 2 A is a 2-prong inquiry that determines in Prong 1 whether a claim recites a judicial exception and if so, then determines in Prong 2 if the recited judicial exception is
integrated into a practical application of that exception. Together, these prongs determine
whether a claim is directed to a judicial exception MPEP 2106.04
Prong 1: The claim(s) recite(s) a product of nature. In particular claim(s) recite(s) a kit
comprising at lest two ligands comprising an antibody that can bind markers expressed
on T-cells i.e. anti-CD3,anti-CD4, anti-CD8, antiCD28 However, antibodies to T-cells
markers are natural products as they exist in the human body. Chen et al. (2006, PTO-892, 11/07/2024) disclose autoantibodies
against subpopulations of lymphocytes comprising CD3,CD4,CD8 (see Abstract). In
addition, Neuber et al. (2006, PTO-892, 11/07/2024) teach
autoantibodies to CD28 are known to exist in human body in healthy and diseased (see
Fig.1). Also, naturally occurring IgM antibodies that bind lymphocytes occur in normal
human and animal blood see Lobo et al (WO2006059176, PTO-892, 11/07/2024, Abstract, page 2; page 9 3rd paragraph). In addition, regarding claim 7, while monoclonal antibodies are made in the
laboratory through generation of monoclonal antibody-producing cells (i.e., hybridomas)
by fusing myeloma cells with desired antibody-producing splenocytes (e.g. B cells), it is noted that autoantibodies present in the blood are a mixture of monoclonal antibodies ,
meaning that each individual autoantibody is produced by a single b-cell clone and
targets a specific epitope on the body’s own proteins see
(https://www.google.com/search?q=autoantibodies+are+present+in+blood+as+a+mixtur
e+of+monoclonal&sca_esv=28b0c132aeb9c2ff&sca_upv=1&rlz=1C1GCEA_enUS1033
US1034&ei=sDDvZtyGBafl5NoPjuXVSA&ved=0ahUKEwjcnquF9NSIAxWnMlkFHY5yF
QkQ4dUDCA8&uact=5&oq=autoantibodies+are+present+in+blood+as+a+mixture+of+m
onoclonal&gs_lp=Egxnd3Mtd2l6LXNlcnAiPmF1dG9hbnRpYm9kaWVzIGFyZSBwcmVz
ZW50IGluIGJsb29kIGFzIGEgbWl4dHVyZSBvZiBtb25vY2xvbmFsSMs_UKsKWIU7cAF4
AJABAJgBsAGgAdAcqgEEMC4yM7gBA8gBAPgBAZgCDqACyxDCAgoQABiwAxjWBB
hHwgIIEAAYogQYiQXCAggQABiABBiiBMICCBAhGKABGMMEwgIKECEYoAEYwwQY
CpgDAIgGAZAGCJIHBDEuMTOgB59u&sclient=gws-wiz-serp).
Prong 2: This judicial exception is not integrated into a practical application because the
claimed nature-based product does not have markedly different characteristics. The
claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception because claims recite only nature of
products. In addition, regarding claim 7, while monoclonal antibodies are made in the
laboratory through generation of monoclonal antibody-producing cells (i.e., hybridomas)
might have a different structure than naturally occurring antibodies, there is no evidence
that structural differences result in change of binding i.e. anti CD3, anti-CD4 etc as
compared to the naturally occurring antibodies that bind the same antigens The recited
additional “murine” element do not add any markedly different characteristics and is
reasonable to conclude that a structural difference is not a marked difference.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Step 2B: Does the claim as a whole amounts to significantly more than the
exception? No. The claim(s) does/do not include additional elements that are sufficient
to amount to significantly more than the judicial exception. While claim 3, recites an
additionally labeled secondary adding such secondary antibody is taught in the prior art
well understood, purely conventional and routinely taken by others as cited below. The
additional reagent must relate to the judicial exception in a significant way e.g. is more
significant than insignificant extra solution activity i.e. data gathering. In addition, more
recent court opinions, explain that even accepting the fact that the step of detecting
autoantibodies to a specific protein is not routing and conventional the court of Appeais
far the Federal Circuit decided in Athena Diagnostics v Mayo Collaborative Services
(Fed Cir, 2017-2508, 2/6/2019) as follows:
PNG
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437
806
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To supply an inventive concept, the additional reagent must go beyond a standard reagent to observe the natural exception
Simply appending well-understood, routine and conventional reagents used in activities previously known to the industry as cited above, specified at a high level of generality, has been held not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception (Guidance at 74624).
Claim Rejections - 35 USC § 101-Response to Arguments
The arguments filed on 02/07/2025 have been considered by the examiner.
On p. 4 applicant argues that the amendments overcome the 35 USC 101 rejection. However, the claim was amended to recite “wherein at least one antibody in the group of ligands comprises a fluorescent or enzymatic label”. The amendment only requires one antibody to comprise a fluorescent or enzymatic label, allowing the other antibodies to remain products of nature. Thus, the amendment does not remedy the 35 USC 101 rejection.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1, 3, and 8 are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by Van Dongen et al. (WO 2010/140885, PTO-892, 11/07/2024).
Regarding claim 1, Van Dongen teaches a kit comprising a group of ligands (see abstract) comprising
an anti-CD8 antibody, an anti-CD4 antibody, an anti-CD57 antibody, an anti-CD28-antibody, and an anti-CD3 antibody, or reactive fragments thereof (see table 3 that teaches CD8, CD4, CD57, CD28, and CD3 antibodies being measured in one study, see page 10 lines 6-14 teaching antibodies against CD8, CD4, CD57, CD28, and CD3),
wherein at least one antibody in the group of ligands comprises a fluorescent or enzymatic label (see abstract that recites the use of fluorescent compounds, see page 6 lines 14-28 teaching the use of fluorochromes).
Regarding claim 3, Van Dongen teaches at least one fluorescently- or enzymatically-labelled antibody (see abstract and page 6 lines 14-28) that specifically recognizes and binds to the anti-CD8 antibody, anti-CD4 antibody, anti-CD 11a antibody, anti-CD57 antibody, anti-CD28-antibody, or anti-CD3 antibody (see page 10 lines 9-14 teaching antibodies against CD4, CD8, CD57, and CD3. See table 3).
Regarding claim 8, Van Dongen teaches wherein the fluorescent label comprises a cyanine (cy), allophycocyanin (APC), fluorescein isothiocyanate (FITC), or phycoerythrin (PE) label (see page 6 lines 14-28 teaching the use of cyanine, allophycocyanin (APC), fluorescein isothiocyanate (FITC), and phycoerythrin (PE) as fluorescent labels).
Claim Rejections - 35 USC § 102-Response to Arguments
The arguments filed on 02/07/2025 have been considered by the examiner.
On p. 5 applicant argues that Van Dongen does not teach both an anti-CD57 antibody and an anti-CD28 antibody. However, on page 10 lines 6-14 of Van Dongen teaches antibodies against CD57 and CD28.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Dongen et al. as applied to claim 1 above, and further in view of Lobo et al. (WO 2006/059176 A1, PTO-892, 11/07/2024).
The teachings of Van Dongen as it pertains to claims 1, 3, and 8 are discussed in the 35 USC 102 rejection above. Van Dongen is silent towards using a monoclonal murine antibody.
Regarding claim 7, Lobo teaches using monoclonal murine anti-CD3 antibodies (see page 27 lines 20-29, see page 28 lines 23-33). Lobo further teaches a monoclonal murine antibody that is specific for CD4 is Leu 3a (see page 15 lines 18-19).
It would have been prima facia obvious to one of ordinary skill in the art at the time of the instant application to combine the kit of ligands taught by Van Dongen with the monoclonal murine antibodies taught by Lobo. Lobo teaches these claimed limitations are beneficial because monoclonal murine antibodies can be specific for different receptors (see page 29 lines 15-18). One of ordinary skill in the art would have been motivated to use monoclonal murine antibodies with Van Dongen’s methods because it can allow for specific binding of CD4, CD8, CD57, and/or CD3. The artisan would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GREGORY S EMCH whose telephone number is (571)272-8149. The examiner can normally be reached Monday - Friday, 7:30 am - 3:30 pm PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Mallari can be reached at (571)272-4729. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678