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
Summary
This is the Non-Final Office action based on the 18/579203 election response filed 07/31/2026.
Claims 1-17 are pending.
Claims 10-16 have been elected and fully examined.
Claims 1-9 and 17 are withdrawn from prosecution.
Election/Restrictions
Applicant's election with traverse of Claims 10-16 in the reply filed on 07/31/2026 is acknowledged. The traversal is on the ground(s) that applicant thinks the examiners position is fundamentally flawed since the prior art recited to show the common technical feature does not teach of the technical feature. This is not found persuasive because other prior art was found. Notably, please see the rejection below showing the combination of TARC and the claimed polymers- the JONES reference.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-9 & 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/31/2026.
Claim Objections
Claims 10-16 are objected to because of the following informalities:
Claims 10-16 in the preamble state “a” “TARC carryover.” This means just “TARC carryover,” and not singular, “a” “TARC carryover.”
In Claim 10, “the group,” should be “a group,” for proper antecedent basis.
In Claim 13, it states, “wherein the carryover is a carryover in a sample probe.” Though this is clear, what is meant in proper grammar is “wherein the carryover is onto a sample probe,” to not be repetitive.
Further, for Claim 15, it is noted that Claim 15 was grouped with Claims 10-14 & 16 in the restriction because it is the same statutory category of invention as Claim 10. However, it is not that it depends on Claim 1, which was unelected. Therefore, as claim 1, was not elected since it was put in a different group since is a different statutory category of invention, it would be appropriate to correct this issue by amending the composition of Claim 1 into Claim 15, or instead, applicant could make Claim 15 dependent on Claim 10, however if done so applicant should ensure that the claim terms have proper antecedent basis.
Appropriate correction is required.
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 10-16 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.
With respect to Claim 10, the preamble is directed to “a method for reducing a TARC carryover,” however the claim body only contains one real step, which is contacting of TARC with one or more components from (B). There for the claim is unclear as to any actual reduction of TARC carryover occurs or not, since there is no actual step in the claim body indicating that. Further, “reducing,” is a relative term, which is not defined in the claims and therefore is unclear. This also applies to Claims 11-16 as they refer back to the preamble, commented on above.
With respect to Claims 11 & 16, they recite specific polymer, however the polymers recited do not have the claimed molecular weights, unless of a particular length. Therefore, in some ways applicant is broadening the claims by claiming the polymers in Claims 11 & 16 after those of Claims 10 & 15.
With respect to Claim 14, it is not clear what “mass % with respect to the solution,” means. Does applicant mean that it is a specific mass percent of the solution as a whole? Or of or in the solution?
With respect to Claim 15, see the objection with respect to Clai 15 as shown above. Further with respect to Claim 15, it is unclear it the “a solution containing TARC,” in the preamble of Claim 15 is the liquid and the TARC already mentioned in Claim 1, or not. If so, it does not have proper antecedent basis in Claim 15, and if it is a different “solution,” it is not clear how it is different from the solution in Claim 10. It is also not clear if the “a liquid solution,” in Claim 15 claim body is the same as the solution already referred to or not. Further it is unclear if the TARC mentioned in Claim 15 is the same TARC as already referred to in Claim 10 or not. As claimed, it does not have proper antecedent basis.
Further with respect to Claim 15, the claim is drawn towards a “method for preventing adsorption of TARC in a solution containing TARC onto a sample probe,” in the preamble, however nothing in the claim body is directed to anything wherein adsorption is tested or determined in any way. Therefore, its unclear if Claim 15 is further limiting or not or if applicant is actually “preventing adsorption,” as they claim or not. Further, since in Claim 15, it claims the “an adsorption inhibitor containing the composition of Claim 1,” it is unclear if TARC itself is part of the adsorption inhibitor or not, since this is claimed in claim 1, or if instead it is the compound which is being inhibited.
Claims 11-14 &16 are also unclear by virtue of their dependency on Claims 10 & 15.
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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over JONES in Proteomic analysis and quantification of cytokines ande chemokines from biomaterial surface adherent macrophages and foreign body giant cells in view of JP3443891 B2.
With respect to Claim 10, JONES teaches of a method for proteomic analysis (analysis of proteins), resulting from a need to analyze biomaterial device implantation. Biomaterial device implantation results in foreign body reaction in the body, the reaction including an influx of monocytes, macrophages, and foreign body giant cells (FBGCs) at the tissue/ biomaterial device interface (abstract).
JONES further teaches of using surface-modified polymers displaying hydrophobic, hydrophilic, and/or ionic chemistries to determine the cytokines/chemokines released from biomaterial-adherent macrophages/FBGCs (abstract).
JONES even further teaches of photographing the polymer, sodium salt of poly (acrylic acid) (PAANa) (Table I, key and table itself) to the surface of the biomaterials (Page 587, column 2, last paragraph & Page 588, column 1, first paragraph).
JONES further teaches of the analysis of cells which are adherent to the biomaterial (Page 587 column 2, 2nd paragraph) and then performing a protein array to determine the presence or absence of 77 cytokines/chemokines (Page 587, column 2, 3rd paragraph & 4th paragraph). JONES teaches that the chemokines which are analyzed including TARC (a chemokine) (Page 590, Table II). JONES teaches that only the cell culture supernatant is analyzed in the protein array, so therefore JONES in the least teaches contacting a sample which might contain TARC (See Table II) with a biomaterial photo-grafted with a sodium salt of poly (acrylic acid) (PAANa) (Table I, key and table itself), the sodium salt of poly acrylic acid (PAAN1). JONES does not teach of TARC adhering to the polymer grafted biomaterial, which is therefore teaching of “reducing TARC carryover,” as claimed since TARC is in the sample and does not adhere/bind (See Table II and Page 589 column 1, paragraph 1).
JONES further teaches of performing graft polymerization, the graft polymers being segmented polymers (which each additional polymer adding to the molecular weight of the overall polymer) (Page 587, column 2, last 2 paragraphs & Table I). Polymer molecular weight is dependent on the size of the polymer monomers grafted together, so while teaching of a polymer shows adjustable size within the claimed molecular weight range of 4,000 to 1,200,000, in case this is not apparent, JP 3443891 is used to remedy this.
JP3443891 teaches a composition comprising 2-methacryloyloxyethylphosphorylcholine used as a protein adsorption inhibitor in biochemical analysis methods and the like, more specifically in a two-site method (i.e. sandwich measurement method) (see e.g. page 1, claim 1; and paragraph [0001]). JP3443891 teaches an example polymer with a molecular weight 32000, which falls within the range of the instant claims (see e.g. Example 2, paragraph [0025], page 4, and also of a polymer molecular weight of 26,000, paragraph [0035]). The polymer can have a concentration of 0.0001 to 5% by weight (see e.g. paragraph [0013]-[0018], page 3). The inhibition of adsorption can be on materials including glass (see e.g. paragraph [0013]-[0018], page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a polymer having the molecular weight as done in JP3443891 in the method of JONES due to fact that the polymer is the active ingredient and due to the success of the composition including the polymer of the size shown in JP3443891 for protein adsorption inhibition (which includes TARC inhibition since is a protein)(JP3443891, paragraph [0008], abstract).
With respect to Claim 11, JONES teaches of contacting a sample which might contain TARC (See Table II) with a biomaterial photo-grafted with a sodium salt of poly (acrylic acid) (PAANa) (Table I, key and table itself), the sodium salt of poly acrylic acid (PAAN1).
With respect to Claim 12, JONES teaches of the claims as shown above, but do not teach of using a buffer.
JP3443891 teaches a composition comprising 2-methacryloyloxyethylphosphorylcholine used as a protein adsorption inhibitor in biochemical analysis methods The polymer can have a concentration of 0.0001 to 5% by weight (see e.g. paragraph [0013]-[0018], page 3). The inhibition of adsorption can be on materials including glass, which can be considered a probe through broadest reasonable interpretation (see e.g. paragraph [0013]-[0018], page 3). JP3443891 further teaches of the composition being in a buffer [paragraph 0004, 0008, 0013-0019, 0023].
It would have been obvious to one of ordinary skill in the art to use a buffer as is done in JP3443891 in the method of JONES due to the advantage this offers in mimicking physiological solutions/conditions (JP3443891, paragraph 0013-0018).
With respect to Claim 13, JONES teaches of the claims as shown above and further teach of using a biomaterial (abstract & biomaterial section) which can be considered a probe through broadest reasonable interpretation. JP3443891 also teaches the inhibition of adsorption can be on materials including glass, which can be considered a probe through broadest reasonable interpretation (see e.g. paragraph [0013]-[0018], page 3).
With respect to Claim 14, JONES teaches of the claims as shown above, but do not teach of the claimed concentration of component B.
JP3443891 teaches a composition comprising 2-methacryloyloxyethylphosphorylcholine used as a protein adsorption inhibitor in biochemical analysis methods The polymer (component B) can have a concentration of 0.0001 to 5% by weight/mass (see e.g. paragraph [0013]-[0018], page 3).
It would have been obvious to one of ordinary skill in the art to use component B in the % as is done in JP3443891 in the method of JONES due to the advantage this has shown for being an effective weight to polymerize and also effectively inhibit adsorption (JP3443891, paragraph 0013-0018, 0008-0011).
With respect to Claim 15, JONES teaches of a method for proteomic analysis (analysis of proteins), resulting from a need to analyze biomaterial device implantation. Biomaterial device implantation results in foreign body reaction in the body, the reaction including an influx of monocytes, macrophages, and foreign body giant cells (FBGCs) at the tissue/ biomaterial device interface (abstract).
JONES further teaches of using surface-modified polymers displaying hydrophobic, hydrophilic, and/or ionic chemistries to determine the cytokines/chemokines released from biomaterial-adherent macrophages/FBGCs (abstract).
JONES even further teaches of photographing the polymer, sodium salt of poly (acrylic acid) (PAANa) (Table I, key and table itself) to the surface of the biomaterials (Page 587, column 2, last paragraph & Page 588, column 1, first paragraph).
JONES further teaches of the analysis of cells which are adherent to the biomaterial (Page 587 column 2, 2nd paragraph) and then performing a protein array to determine the presence or absence of 77 cytokines/chemokines (Page 587, column 2, 3rd paragraph & 4th paragraph). JONES teaches that the chemokines which are analyzed including TARC (a chemokine) (Page 590, Table II). JONES teaches that only the cell culture supernatant is analyzed in the protein array, so therefore JONES in the least teaches contacting a sample which might contain TARC (See Table II) with a biomaterial photo-grafted with a sodium salt of poly (acrylic acid) (PAANa) (Table I, key and table itself), the sodium salt of poly acrylic acid (PAAN1). JONES does not teach of TARC adhering to the polymer grafted biomaterial, which is therefore teaching of “reducing TARC carryover,” as claimed since TARC is in the sample and does not adhere/bind (See Table II and Page 589 column 1, paragraph 1).
JONES further teaches of performing graft polymerization, the graft polymers being segmented polymers (which each additional polymer adding to the molecular weight of the overall polymer) (Page 587, column 2, last 2 paragraphs & Table I). Polymer molecular weight is dependent on the size of the polymer monomers grafted together, so while teaching of a polymer shows adjustable size within the claimed molecular weight range of 4,000 to 1,200,000, in case this is not apparent, JP 3443891 is used to remedy this. Also, JONES does not call out adsorption inhibition.
JP3443891 teaches a composition comprising 2-methacryloyloxyethylphosphorylcholine used as a protein adsorption inhibitor in biochemical analysis methods and the like, more specifically in a two-site method (i.e. sandwich measurement method) (see e.g. page 1, claim 1; and paragraph [0001]). JP3443891 teaches an example polymer with a molecular weight 32000, which falls within the range of the instant claims (see e.g. Example 2, paragraph [0025], page 4, and also of a polymer molecular weight of 26,000, paragraph [0035]). The polymer can have a concentration of 0.0001 to 5% by weight (see e.g. paragraph [0013]-[0018], page 3). The inhibition of adsorption can be on materials including glass (see e.g. paragraph [0013]-[0018], page 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a polymer having the molecular weight as done in JP3443891 in the method of JONES to inhibit adsorption, due to fact that the polymer is the active ingredient and due to the success of the composition including the polymer of the size shown in JP3443891 for protein adsorption inhibition (which includes TARC inhibition since is a protein)(JP3443891, paragraph [0008], abstract).
With respect to Claim 16, JONES teaches of contacting a sample which might contain TARC (See Table II) with a biomaterial photo-grafted with a sodium salt of poly (acrylic acid) (PAANa) (Table I, key and table itself), the sodium salt of poly acrylic acid (PAAN1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
BOAKYE in US 20180171007 teaches a liquid composition comprising CCL17 (i.e., TARC) and 0.05% Tween-20 (i.e., the sugar fatty acid ester-type nonionic surfactant ) (see [0010, 0194]), and Tween-20 also reads on a polyoxyethylene (20) sorbitan monolaurate.
IMAI in US 6793917 teaches of a type CC chemokine-like protein (abstract), which is TARC and further has an amino acid sequence which is acidic or basic and which has the claimed “average” molecular weight (column 2, lines 43-line 67- column 3, line 60).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Prosecution Insights