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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group II, claims 17-23 and 25-32, without traverse, filed November 13, 2025 is acknowledged and has been entered. Claim 24 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention.
Applicant's election of Species, with traverse, is also acknowledged and has been entered. Applicant elected:
Species A1) TLR ligands as ligand of intracellular receptors of blood cells that have an activating effect on blood cells recited in claims 18 and 19. However, upon further consideration, antigens and mitogens have been rejoined for prosecution on the merits.
Species B) modulator TLR agonists recited in claim 22.
Species C) co-activator cytokine recited in claim 23.
Species D2) rheumatoid arthritis as autoimmune disease recited in claim 25.
Claims 20 and 21 are also withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected species. Accordingly, claims 17-32 are pending. Claims 17-19, 22, 23, and 25-32 are under examination.
2. Applicant traverses the species election requirement, in particular, Species D on the grounds that a search for autoimmune will reveal the conditions listed in claim 25, while similarly a search for any one of those diseases would result in autoimmune disorders; hence, there is no undue search burden on the Office.
Applicant’s argument is not persuasive because the requirement to demonstrate search burden that pertains to applications filed under 35 U.S.C. 111(a) (see MPEP 801) does not apply to 35 U.S.C. 371 national stage applications. The present application was filed under 35 U.S.C. 371 and is therefore subject to different analysis for restriction, namely unity of invention (see also MPEP 823 and 1800). There is no corresponding requirement to demonstrate search burden in applications filed under 35 U.S.C. 371. Since Applicant’s argument does not address unity of invention, it is maintained that unity is lacking for reasons of record.
Priority
3. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
4. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) or (f), 365(a) or (b) or 386(a). Based on the filing receipt, the effective filing date of this National Stage application, which is a 371 of PCT/PE2020/075894 filed 09/16/2020, is September 17, 2019 which is the filing date of Foreign Application GERMANY 10 2019 214 137.1 filed 09/17/2019 from which the benefit of foreign priority is claimed.
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.
With the species election, claim limitations under examination are as follows:
Claim 17, lines 1, 7-12 and 22-29 (autoimmune disease).
Claim 18, lines 1-2, 5-6, and 30-31 (TLR ligands: ligands of intracellular receptors of blood cells that have an activating or inhibitory effect on blood cells; upon further consideration, antigens and mitogens have been rejoined for prosecution on the merits).
Claim 19, lines 1 and 37-38 (TLR ligands: ligands of intracellular receptors of blood cells that have an activating or inhibitory effect on blood cells; upon further consideration, antigens and mitogens have been rejoined for prosecution on the merits).
Claim 22, lines 1-2, and 5 (TLR agonists: modulator that modulates blood cells or immune cells).
Claim 23, lines 1-2, and 4 (cytokines: co-activator).
Claim 25, lines 1-2 and 13 (rheumatoid arthritis).
Claim 30, lines 1, 7-12, and 22-36: steps a)-d) (autoimmune disease).
Claim 31, lines 1, 7-12, and 23-35: steps a)-c) (autoimmune disease).
Claim 32, lines 1, 7-12 and 22-27 (autoimmune disease).
5. Claims 17-19, 22, 23, and 25-32 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 17 is confusing in reciting “An in vitro method… comprising the step of using a kit, wherein the kit comprises…” because the preamble is directed to a method whereas the limitations recite components of a product which is a kit. Accordingly, it is unclear how claim 17 is drawn to method.
Claim 17 is indefinite in reciting “An in vitro method… comprising the step of using a kit, wherein the kit comprises…” because the method step simply defines the use of “a kit” and the corresponding kit components but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process steps Applicant intends to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim 17, lines 8-9 is vague and indefinite in reciting, “prognostic assessment of the prospects of success” because it is unclear what is encompassed in the recitation of “prospects of success” as used in the claim. In particular, “prospects” and “success” are subjective terms lacking a comparative basis for defining its metes and bounds.
Claim 30, lines 8-9 is indefinite in reciting, “prognostic assessment of the prospects of success” because it is unclear what is encompassed in the recitation of “prospects of success” as used in the claim. In particular, “prospects” and “success” are subjective terms lacking a comparative basis for defining its metes and bounds.
Claim 30, step a) is ambiguous in reciting “in addition to any activators present in the whole blood”, “in addition to any inhibitors present in the whole blood”, and “in addition to any modulators present in the whole blood” because it is unclear how these “any activators” or “any inhibitors”, or “any modulators” are present in the whole blood. Additionally, it is further unclear what is encompassed in the recitation of these “any activators” or “any inhibitors”, or “any modulators” and what essential structural and/or functional cooperative relationship exists between the instant “at least one activator that activates blood cells or immune cells”, “at least one inhibitor that inhibits blood cells or immune cells”, or “at least one modulator that modulates blood cells or immune cells” that is mixed with the whole blood and the “any activators present in the whole blood” or “any inhibitors present in the whole blood”, or “any modulators present in the whole blood.”
Claim 31, lines 8-9 is indefinite in reciting, “prognostic assessment of the prospects of success” because it is unclear what is encompassed in the recitation of “prospects of success” as used in the claim. In particular, “prospects” and “success” are subjective terms lacking a comparative basis for defining its metes and bounds.
Claim 31, step a) is ambiguous in reciting “in addition to any activators present in the whole blood”, “in addition to any inhibitors present in the whole blood”, and “in addition to any modulators present in the whole blood” because it is unclear how these “any activators” or “any inhibitors”, or “any modulators” are present in the whole blood. Additionally, it is further unclear what is encompassed in the recitation of these “any activators” or “any inhibitors”, or “any modulators” and what essential structural and/or functional cooperative relationship exists between the instant “at least one activator that activates blood cells or immune cells”, “at least one inhibitor that inhibits blood cells or immune cells”, or “at least one modulator that modulates blood cells or immune cells” that is mixed with the whole blood and the “any activators present in the whole blood” or “any inhibitors present in the whole blood”, or “any modulators present in the whole blood.”
Claim 32 is confusing in reciting “An in vitro method… using a combination or a mixture comprising …” because the preamble is directed to a method whereas the limitations recite components of a resultant combination or mixture appearing to encompass a product. Accordingly, it is unclear how claim 32 is drawn to method.
Claim 32 is indefinite in reciting “An in vitro method… comprising using a combination or a mixture comprising…” because the method step simply defines the use of a combination or mixture of components but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process steps Applicant intends to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim 32, lines 8-9 is indefinite in reciting, “prognostic assessment of the prospects of success” because it is unclear what is encompassed in the recitation of “prospects of success” as used in the claim. In particular, “prospects” and “success” are subjective terms lacking a comparative basis for defining its metes and bounds.
Claim 32, in lines 23-27 is ambiguous in reciting “in addition to any activators present in the whole blood”, “in addition to any inhibitors present in the whole blood”, and “in addition to any modulators present in the whole blood” because it is unclear how these “any activators” or “any inhibitors”, or “any modulators” are present in the whole blood. Additionally, it is further unclear what is encompassed in the recitation of these “any activators” or “any inhibitors”, or “any modulators” and what essential structural and/or functional cooperative relationship exists between the instant “at least one activator that activates blood cells or immune cells”, “at least one inhibitor that inhibits blood cells or immune cells”, or “at least one modulator that modulates blood cells or immune cells” that is mixed with the whole blood and the “any activators present in the whole blood” or “any inhibitors present in the whole blood”, or “any modulators present in the whole blood.”
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
With the species election, claim limitations under examination are as follows:
Claim 17, lines 1, 7-12 and 22-29 (autoimmune disease).
Claim 18, lines 1-2, 5-6, and 30-31 (TLR ligands: ligands of intracellular receptors of blood cells that have an activating or inhibitory effect on blood cells; upon further consideration, antigens and mitogens have been rejoined for prosecution on the merits).
Claim 19, lines 1 and 37-38 (TLR ligands: ligands of intracellular receptors of blood cells that have an activating or inhibitory effect on blood cells; upon further consideration, antigens and mitogens have been rejoined for prosecution on the merits).
Claim 22, lines 1-2, and 5 (TLR agonists: modulator that modulates blood cells or immune cells).
Claim 23, lines 1-2, and 4 (cytokines: co-activator).
Claim 25, lines 1-2 and 13 (rheumatoid arthritis).
Claim 30, lines 1, 7-12, and 22-36: steps a)-d) (autoimmune disease).
Claim 31, lines 1, 7-12, and 23-35: steps a)-c) (autoimmune disease).
Claim 32, lines 1, 7-12 and 22-27 (autoimmune disease).
6. Claim 17-19, 23 and 26-32 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Schmolz (US 6,410,334).
Schmolz discloses an in vitro method for diagnostics relating to autoimmune disease (immune defense activity) and therapy therefor comprising the step of using a kit (Abstract). The kit comprises: a blood collection (sampling) system including a syringe barrel (cylinder) (Abstract; Figure 1; col. 3, line 30 to col. 4, line 19); a nutrient medium for blood present in the blood collection container; and, at least one activator (or stimulant) which includes antigens, bacterial antigens (superantigens), or mitogens that activate blood cells or immune cells, each present in the blood collection container in liquid or dissolved form (col. 2, lines 39 to col. 3, line 13; col. 3, line 30 to col. 5, line 10). Schmolz specifically teaches that the at least one activator is a toll-like receptor (TLR) ligand such as lipopolysaccharide (LPS) or a muramyl peptide. The kit further comprises at least one co-activator; wherein the co-activator is a cytokine (interleukin 4 (IL-4), interferon gamma (IFNγ). The kit as taught by Schmolz further comprises an anticoagulant, a heating block, a thermostatically controllable device, and/or a thermoblock. The kit also comprises a separating component associated with the blood collection container for separation of a supernatant and a sediment (centrifuge) (col. 2, lines 39 to col. 3, line 13).
The method as taught by Schmolz comprises: a) preparing a mixture comprising whole blood, a nutrient medium for whole blood, and at least one activator that activates blood cells or immune cells; b) incubating the prepared mixture; c) separating a messenger-substance-containing supernatant formed in step c) from a cell-containing sediment or formed through centrifugation of the incubated prepared mixture (col. 1, lines 58-64); and, d) detecting and/or determining messenger substances such as cytokines present in the supernatant or intracellular activation markers of blood cells or immune cells, present in the sediment (col. 1, line 58 to col. 2, line 22; col. 2, lines 39 to col. 3, line 13; col. 5, line 39 to col. 6, line 24). Accordingly, Schmolz appears to read on Applicant’s claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
7. Claims 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Schmolz (US 6,410,334) in view of Schmolz (US 2008/0213751).
Schmolz ‘334 is discussed supra. Schmolz ‘334 is silent in teaching a modulator that modulates blood cell or immune cells including TLR agonist and rheumatoid arthritis as an autoimmune disease.
Schmolz ‘751 discloses an in vitro method that permits determination of immunological performance of blood cells in response to pathogenic stimulation. Schmolz ‘751 teaches activating (stimulating) blood cells or immune cells in culture medium with TLR ligands including LPS, glycans, and muramyl peptides and using TLR agonists (Diclofenac, Calendula, Cortisone) to modulate the blood cells or immune cells [0006, 0008, 0034]. Schmolz ‘751 teaches that the method is used in diagnosing autoimmune diseases such as inflammatory disease including systemic inflammatory response syndrome (SIRS), rheumatoid arthritis (RA), and psoriasis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate the teaching of Schmolz ‘751 of TLR agonists and corresponding inflammatory disease therapy into the in vitro method of Schmolz ‘334 because Schmolz ‘334, indeed, taught activating blood cells or immune cells with TLR ligands including LPS and muramyl peptides for purposes of applicability. One of ordinary skill would have had reasonable expectation of success in incorporating the TLR agonists for inflammatory disease therapy as taught by Schmolz ‘751 into the method of Schmolz ‘334 because both of Schmolz ‘334 and Schmolz ‘751 teach analogous art of determining autoimmune function or activity.
8. No claims are allowed.
Remarks
9. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Schmolz et al. (US 2014/0080135) disclose a method for recognizing and/or characterizing cellular activity patterns.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
January 18, 2026