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 .
Claim Rejections - 35 USC § 112
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 14-20 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. Independent claim 14 has been amended to recite that the agent has a pH value of 8.5-14. This specific pH value for the agent having the chemical formula (I) recited in claim 14, wherein R1 is -H and R2 is a substituted C1-C16 alkyl, wherein “substituted” means being substituted with -OH, represents new matter that is not disclosed in the specification as originally filed. The only place in the specification where a pH of 8.5 is disclosed in the specification is in paragraph 0204 and table 6 of the US patent publication of this application (US 2023/0152304), where ammonium chloride is used as the agent to disaggregate platelets or reduce platelet aggregation in a sample, not an agent having the formula (I) recited in claim 14, wherein R1 is -H and R2 is a substituted C1-C16 alkyl, wherein “substituted” means being substituted with -OH. Therefore, the specification contains no teaching of an agent with the specific formula (I) recited in claims 14-20 having a pH of between 8.5 and 14 (claim 14), or between 8.5 and 11 (claim 16). The specific pH ranges of 8.5-14 and 8.5-11 are not disclosed in the specification as originally filed for an agent having the formula (I) recited in independent claim 14. Only a pH range of 7.5-11.0 (see paragraphs 0025, 0037, 0047, 0089, 0121 and 0155 in the PG publication US 2023/0152304) and a pH range of 9.5-11.0 (see paragraphs 0089, 0121 and 0155 in the PG publication US 2023/0152304) are disclosed in the specification for an agent having the formula (I) recited in claim 14, wherein R1 is -H and R2 is a substituted C1-C16 alkyl, wherein “substituted” means being substituted with -OH.
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 1-2, 4-8 and 20 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 1 is indefinite since the preamble recites a method for counting platelets in a blood sample in an in vitro blood test, but none of the steps of the method actually recite counting platelets. The only positively recited step of the method in claim 1 is treating a blood sample with the composition having formula (I). See this same problem in claim 20 with regards to treating a blood sample with the agent of claim 14. Dependent claims 2 and 4-8 are rejected under 35 USC 112(b) for the same reason in view of their dependency on claim 1.
Inventorship
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 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 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.
Claim(s) 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naldrett (US 2004/0069707).
With regards to claims 14-17, Naldrett teaches of an agent or composition comprising ethanolamine having a pH of 10.2 at a concentration of 20 mM (mmol/L). See paragraph 0025 in Naldrett. Ethanolamine is a compound having the same formula (I) recited in claims 14 and 15, wherein R1 is -H and R2 is a substituted C1-C16 alkyl or a substituted C1-C10 alkyl, wherein “substituted” means being substituted with -OH. The pH of 10.2 for the composition taught by Naldrett is in the range of 8.5-14 recited in instant claim 14, and in the range of 8.5-11 recited in instant claim 16. The concentration of ethanolamine taught by Naldrett (20 mM or 20 mmol/L) is in the range of 1-50 mmol/L recited in instant claim 14, and in the range of 2-20 mmol/L recited in instant claim 17. While Naldrett does not specifically test that the agent or composition containing ethanolamine serves to reduce platelet aggregation interference in an in vitro blood test, it is noted that this refers to an intended use of the agent or composition. It has been held that a statement of intended use of a composition in the preamble of a composition claim or the fact that a composition is intended for a new and unobvious use does not render an otherwise old or suggested composition patentable. See In re Pearson, 181 USPQ 641 (CCPA 1974).
Claim(s) 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by John et al (US 2015/0359218).
With regards to claims 14-17, John et al teach of an agent or composition comprising ethanolamine having a pH of 9.0 at a concentration of 10 mM (mmol/L). See paragraph 0038 in John et al. Ethanolamine is a compound having the same formula (I) recited in claims 14 and 15, wherein R1 is -H and R2 is a substituted C1-C16 alkyl or a substituted C1-C10 alkyl, wherein “substituted” means being substituted with -OH. The pH of 9.0 for the composition taught by John et al is in the range of 8.5-14 recited in instant claim 14, and in the range of 8.5-11 recited in instant claim 16. The concentration of ethanolamine taught by John et al (10 mM or 10 mmol/L) is in the range of 1-50 mmol/L recited in instant claim 14, and in the range of 2-20 mmol/L recited in instant claim 17. While John et al do not specifically test that the agent or composition containing ethanolamine serves to reduce platelet aggregation interference in an in vitro blood test, it is noted that this refers to an intended use of the agent or composition. It has been held that a statement of intended use of a composition in the preamble of a composition claim or the fact that a composition is intended for a new and unobvious use does not render an otherwise old or suggested composition patentable. See In re Pearson, 181 USPQ 641 (CCPA 1974).
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.
Claim(s) 1-2 and 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osawa et al (US 2017/0205433).
With regards to claims 1-2, and particularly when the compound of formula (I) in claims 1-2 comprises R1= -H and R2= a substituted C1-C16 alkyl, wherein “substituted” means being substituted with -OH, Osawa et al teach of an agent or composition for use in analyzing a blood cell component in an in vitro blood sample collected from a finger of an individual (i.e. an in vitro blood test) (see the abstract and paragraph 0015 in Osawa et al). The agent or composition comprises a diluent buffer containing an internal standard substance in order to accurately determine a dilution factor of a blood sample to which the diluent buffer is added. In one embodiment, the internal standard substance in the diluent buffer composition comprises ethanolamine (see paragraphs 0029, 0039 and 0172, and Table 1 in Osawa et al), which is a compound having formula H-NH-CH2-CH2-OH and which meets the definition of the compound having formula (I) in claims 1-2, wherein R1= -H and R2= a substituted C1-C16 alkyl (claim 1) or R2= a substituted C1-C10 alkyl (claim 2), wherein “substituted” means being substituted with -OH. The composition of the diluent buffer disclosed in Table 1 of Osawa et al comprises ethanolamine in a concentration of 4.37 mM or 4.37 mmol/L. See the abstract, paragraphs 0018-0020, 0022-0023, 0029, 0037-0039, 0140-0141 and 0172-0176, and Table 1 in Osawa et al.
Osawa et al fail to teach of a method for preventing and/or eliminating platelet aggregation in a blood sample in an in vitro blood test using the diluent buffer agent or composition described above. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the diluent buffer agent or composition comprising ethanolamine taught by Osawa et al for preventing and/or eliminating platelet aggregation in a blood sample in an in vitro blood test because the ethanolamine is the same type of chemical recited in claims 1-2 which performs this function in a blood sample when performing an in vitro blood test, and thus, one of ordinary skill in the art would fully expect the ethanolamine in the diluent buffer agent or composition taught by Osawa et al to also prevent or eliminate platelet aggregation in a blood sample in an in vitro blood test in the same manner as taught for the instant invention. The mere discovery or recognition of an inherent property in an otherwise old composition cannot distinguish a composition from the prior art (see In re Tomlinsin, 150 USPQ 623), and the discovery of a new or different function for a compound is not a patentable distinction (see In re Lintner, 173 USPQ 356 and/or In re Jones, 50 USPQ 48).
With regards to claim 4, Osawa et al teach that the diluent buffer agent or composition has a pH in a range of preferably 6 to 8, which is a pH of at least 3.0 or a pH of 7.5-11, as recited in claim 16. See paragraph 0174 in Osawa et al.
With regards to claim 5, the pKa value of the ethanolamine in the diluent buffer composition taught by Osawa et al is between 1-16 or between 4-14 since the ethanolamine taught by Osawa et al is the same type of compound having formula (I) as recited in claim 1, wherein R1= -H and R2= a substituted C1-C16 alkyl, wherein “substituted” means being substituted with -OH, and this compound has a pKa value between 1-16 or between 4-14.
With regards to claim 6, the ethanolamine in the diluent buffer composition taught by Osawa et al is present in the composition at a concentration of 4.37 mM or 4.37 mmol/L, which is in the range of 1-50 mmol/L or 2-20 mmol/L recited in instant claim 6.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osawa et al (US 2017/0205433) in view of Ginsburg (US 3,000,836). For a teaching of Osawa et al, see previous paragraphs in this Office action.
With regards to claim 7, Osawa et al fail to teach that the diluent buffer agent or composition further comprises an ammonium-containing compound.
Ginsburg teaches of a stabilized blood product comprising human whole blood that is processed and treated with preservative materials in order to eliminate microbial and bacterial growth in the blood product, and thus stabilize the blood product. Ginsburg teaches that a suitable type of preservative to add to the blood product in order to stabilize the product against microbial and bacterial growth is cetyl dimethyl benzyl ammonium chloride, which is an ammonium-containing compound. See lines 32-47 in column 2 and lines 13-32 in column 3 of Ginsburg.
Based upon the combination of Osawa et al and Ginsburg, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an ammonium-containing compound to the diluent buffer agent or composition taught by Osawa et al because Osawa et al teach that the diluent buffer composition can contain a preservative therein as an antimicrobial agent (see paragraphs 0175-0176 in Osawa et al), and Ginsburg teaches that an ammonium-containing compound (i.e. cetyl dimethyl benzyl ammonium chloride) is an effective antimicrobial or antibacterial agent to include in a blood product for preserving the blood product.
With regards to claim 8, Osawa et al teach that the blood sample combined with the diluent buffer composition has a pH of at least 3.0 (see paragraph 0174 in Osawa et al where a pH between 6 and 8 is disclosed). It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the ammonium-containing compound taught by Ginsburg to the blood sample containing the diluent buffer agent or composition taught by Osawa et al in a concentration of 1-50 mmol/L or of 2-20 mmol/L because the ammonium-containing compound performs the function of stabilizing the blood sample by preventing microbial or bacterial growth therein, and one of ordinary skill in the art would adjust the concentration of the ammonium-containing compound added to the blood sample taught by the combination of Osawa et al and Ginsburg in order to optimize a desired degree of microbial or bacterial growth prevention.
Response to Arguments
Applicant's arguments filed August 14, 2026 have been fully considered but they are not persuasive.
The previous objection to the abstract made in the last Office action mailed on April 16, 2026 has been withdrawn in view of the amendments to the abstract. The previous rejection of claim 16 made in the last Office action under 35 USC 112(b) has also been withdrawn in view of the amendments made to the claims. However, some of the amended claims are newly rejected under 35 USC 112(a) and 112(b) for the reasons set forth above and as necessitated by the amendments made to the claims.
Applicant argues the previous rejection of claims 14-17 and 19 under 35 USC 102(a)(1) as being anticipated by Osawa et al by stating that Osawa et al fail to teach “wherein the agent has a pH value of 8.5-14, and wherein the agent is used for reducing platelet aggregation interference in the in vitro blood test”. In response to this argument, it is noted that the rejection of claims 14-17 and 19 under 35 USC 102(a)(1) as being anticipated by Osawa et al has been withdrawn in view of the amendments made to the claims. However, it is noted that the recited pH range of 8.5-14 in amended claim 14 represents new matter not supported by the specification as originally filed, as noted above in the rejection of claims 14-20 under 35 USC 112(a). It is also noted that amended claims 14-17 are now rejected under 35 USC 102(a)(1) as being anticipated by both Naldrett (US 2004/0069707) and John et al (US 2015/035928) for the reasons set forth above. Both of these references teach of an agent comprising ethanolamine having a pH value of between 8.5-14. While these references do not teach that the agent is “used for reducing platelet aggregation interference in an in vitro blood test”, this limitation in claims 14-17 has not been given patentable weight since it has been held that a statement of intended use of a composition or the fact that a composition is intended for a new and unobvious use does not render an otherwise old or suggested composition patentable. See In re Pearson, 181 USPQ 641 (CCPA 1974).
Applicant argues the rejection of the claims 1-2 and 4-6 under 35 USC 103 as being obvious over Osawa et al by stating that Osawa et al fail to teach of preventing and/or eliminating platelet aggregation in a blood sample in order to accurately count platelets since Osawa et al do not teach of counting platelets in a blood sample at all. This argument is not persuasive since Osawa et al do teach of adding ethanolamine to a dilution buffer used to dilute a blood sample and then counting different blood cells in the diluted blood sample, wherein the blood cells counted comprise leucocytes, erythrocytes and platelets. See paragraphs 0328-0329 and Figure 5 in Osawa et al. Therefore, in this method, platelet aggregation would be prevented or eliminated in the same manner as in the instant invention since the ethanolamine taught by Osawa et al has the same formula (I) as recited in instant claim 1. In addition, the mere discovery or recognition of an inherent property in an otherwise old composition cannot distinguish a composition from the prior art (see In re Tomlinsin, 150 USPQ 623), and the discovery of a new or different function for a compound is not a patentable distinction (see In re Lintner, 173 USPQ 356 and/or In re Jones, 50 USPQ 48).
Applicant also argues the rejection of claims 7-8 under 35 USC 103 as being obvious over Osawa et al in view of Ginsburg by stating that the cetyl benzyl ammonium chloride taught by Ginsburg is not an ammonium ion (NH4+)-containing compound, as now recited in claim 7. This argument is not persuasive since claim 7 recites that the composition can further comprise an ammonium ion-containing compound having a chloride anion as one of the possible additional components of the composition recited in claim 1. The cetyl benzyl ammonium chloride taught by Ginsburg is an ammonium ion-containing compound having a chloride anion since it is a quaternary ammonium compound containing a positively charged ammonium ion (R4N+) balanced by a chloride anion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the ammonium-containing compound taught by Ginsburg to the diluent buffer agent or composition taught by Osawa et al because Osawa et al teach that the diluent buffer composition can contain a preservative therein as an antimicrobial agent (see paragraphs 0175-0176 in Osawa et al), and Ginsburg teaches that an ammonium-containing compound having a chloride anion (i.e. cetyl dimethyl benzyl ammonium chloride) is an effective antimicrobial or antibacterial agent to include in a blood product for preserving the blood product.
For all of the above reasons, Applicant’s arguments are not persuasive.
Conclusion
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 MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 October 13, 2026
