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 1-12 are pending, all of which have been considered on the merits.
Priority
Acknowledgement is made of Applicants’ claim for benefit under 35 USC 120 as a continuation of prior-filed US application 16/479392 (now US Patent 11882823), which is a national stage entry under 35 USC 371 of PCT/US18/14446 (filed 1/19/2018), which claims benefit to prior-filed US Provisional application 62/449076 (filed 1/22/2017).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 is directed to the composition of claim 1, and provides the additional limitation “the composition is contacted with a sample that is subsequently frozen”. This limitation is directed to future operation/use of the composition, but it does not further limit the composition per se. Because claim 12 does not further limit the composition, it is rejected under 35 USC 112(d), as failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-3, 6-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Granger et al (US 6579672).
Granger et al teaches a sterile aqueous collection fluid, it generally comprises: a sterile buffered aqueous solution, an aliphatic aldehyde, one or more heavy metal salts, and optionally an anticoagulant (See col. 2, ln 1-14). The fluid can further comprise cell nutrients (dextrose, ATP, inosine), antibiotics, and platelet stabilizers (See col. 3, ln 1-65).
Example 2 sets forth a specific formulation comprising:
PNG
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160
442
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This formulation has a pH of 7.4 (col. 5, ln 40-51).
The formula is comparable to that claimed as follows: Regarding claims 1-3, 7: The formulation of Example 2 contains:
chromium (III) chloride and manganese chloride (common name for manganese II chloride), which read on a heavy metal salt, the heavy metal salt having an atomic number from 20 to 60 (chromium having the atomic number 24, manganese having atomic number 25).
…this also reads on wherein the heavy metal salt is chromium III chloride and manganese II chloride of claim 2.
…this also reads on wherein the chromium III chloride concentration in the composition is 0.0002 to 0.1M (the concentration is 0.019 M), and wherein the manganese II chloride is from 0.0001 to 0.1 M (the concentration is 0.025 M).
Dextrose (D-glucose), which reads on a saccharide. The D-glucose is present at 2.22 M, which is within the claimed range of 1.5 to 3.0 M.
The formulation has a pH of 7.4, which is within the claimed range of 5.9 to 8.0.
The formulation is aqueous, so it necessarily contains water, which reads on a solvent.
Paraformaldehyde, which is an aliphatic aldehyde, and specifically contains formaldehyde.
The formulation of Example 2 contains 0.33 M paraformaldehyde, which is slightly higher than the range currently claimed. However, Granger et al teach that the concentration of the aliphatic aldehyde can range from 0.15 to 1.0 M (See col. 3, ln 41-42). Therefore, while the exemplified concentration is higher, there is a teaching in the same reference that the concentration can be as low as 0.15M. The fact that the prior art range overlaps the current claimed range renders the instant claimed range prima facie obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Regarding claim 12: Claim 12 does not further limit claim 1, so it is rejected for the same reasons as above.
Regarding claim 6: Following the discussion of claim 1 above, Granger et al teach the aliphatic aldehyde can be present in an amount of 0.15 to 1.0 M. This range is slightly higher than the range of claim 6 (capping out at 0.10 M). However, the difference between 0.10 and 0.15 is considered sufficiently close that one would expect them to have the same properties. The basis for concluding the values would have the same properties is based on the fact that both the instant application and Granger et al teach the compositions are suitable for stabilization of biological post draw specimens. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05(I). There is no evidence of criticality associated with the claimed range currently of record.
Regarding claim 8: Following the discussion of claim 6 above, the formulation of Example 2 contains chloramphenicol and neomycin sulphate, both of which are bacterial growth inhibiting preservatives.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Granger et al (US 6579672), in view of Brake et al (US 3847738).
The teachings of Granger et al are set forth above.
Regarding claim 4: Following the discussion of claim 1 above, Granger et al teaches inclusion of cell nutrients, including saccharide dextrose (D-glucose). However Granger et al does not teach inclusion of fructose.
Brake et al is relied upon to show that in solutions intended for blood sample collection and preservation, dextrose and fructose were equivalent sugar energy sources (See col. 3, ln 37-45). Given that Brake et al teach both dextrose and fructose are equivalents as far as sugar energy sources in blood collection solutions, it would have been prima facie obvious to have substituted fructose for the dextrose used in the formulation of Example 2 of Granger et al. This conclusion of obviousness is based on the substitution rationale. Based on the explicit stated equivalency, one would have had a reasonable expectation of predictable results in making the substitution.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Granger et al (US 6579672), in view of Louderback et al (US 3558522).
The teachings of Granger et al are set forth above.
Regarding claim 9: Granger et al teaches inclusion of anti-bacterial agents chloramphenicol and neomycin sulphate, which serve as bacterial growth inhibiting preservatives. Granger et al does not teach sodium azide at a concentration of 0.005 to 0.02% (w/v) as the preservative.
Louderback et al is relied upon to evidence that, in solutions for hematologic samples it was standard to include a small amount of antibiotic or preservative. Louderback et al disclose both neomycin and sodium azide as suitable bacteriostatic agents (See col. 3, ln 20-26).
Given that Louderback et al teach both neomycin and sodium azide were suitable as bacteriostatic agents for use with blood samples, it would have been prima facie obvious to have substituted sodium azide for the neomycin used in the formulation of Example 2 of Granger et al. This conclusion of obviousness is based on the substitution rationale. Based on the teachings of Louderback et al, one would have had a reasonable expectation that sodium azide would have bacteriostatic properties, in the same way as the neomycin sulphate taught by Granger et al. Thus one would have had a reasonable expectation of predictable results.
Regarding the concentration of sodium azide taught. It was well within the purview of the skilled artisan to determine the appropriate amount of bacteriostatic agent, including sodium azide. The amount of bacteriostatic agent provided in a composition is a result effective variable. The claimed range of 0.005 to 0.2% (w/v) is considered to have been prima facie obvious as a matter of routine optimization.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Granger et al (US 6579672), in view of Pugia et al (US 2017/0137805).
The teachings of Granger et al are set forth above.
Regarding claim 9: Following the discussion of claim 8 above, Granger et al teaches their formulation comprises a buffered aqueous solution with a pH of about 7.4. Granger et al does not specify what buffer is present in the formulation of Example 2.
Pugia et al teach a similar blood collection/preservation solution, comprising inter alia, heavy metal salts, saccharides, and cell nutrients (See ¶0020). The solution further comprises a buffered aqueous medium, having a pH of about 7 (physiological pH) (See ¶0022, and 0025-0036). Amongst the suitable buffers disclosed are MOPS and MES (See ¶0034) and 2-(4-hydroxyethyl)-1-piperazineethanesulfonic acid (HEPES) (See ¶0035).
Because Granger is silent with specifics as to what buffer can be used, it would have been prima facie obvious to look to the art to determine an appropriate buffer. Given that both Granger et al and Pugia et al are providing blood collection/preservation solutions with similar compositions, it would have been prima facie to have selected HEPES, MOPS or MES, as taught by Pugia et al, for use in the formulation of Granger et al. This conclusion of obviousness is based on teachings, suggestion, motivation rationale. Pugia et al teaches that HEPES, MOPS and MES are appropriate buffering agents for the same purpose as Granger et al. There would have been a reasonable expectation of successfully using HEPES, MOPS or MES in the Example 2 formulation of Granger et al based on the disclosure of Pugia et al that they are appropriate buffers for use with blood collection fluid and buffer to approximately 7 (physiological pH).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11882823.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim anticipates the instant claims.
Patented claim 7 is drawn to a method which involves use of a composition which anticipates all current claims. Specifically, the patented method uses a composition comprising:
chromium (III) chloride at a concentration of 0.03M and manganese (II) chloride having a concentration of 0.2M (reads on heavy metal);
fructose, at a concentration of 2.6 M (reads on saccharide)
formaldehyde, having a concentration of 0.1 M (reads on aliphatic aldehyde)
HEPES buffer (which reads on a solvent);
sodium azide at 0.01% (w/v) (reads on bacterial growth inhibiting preservative).
As the patented claim uses the composition, it necessarily teaches the composition, per se.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
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