-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 .
Applicant’s response dated May 8, 2026 is acknowledged.
Priority
This application is a continuation of 17/262,790 filed on 01/25/2021, which is a 371 of
PCT/US19/43675 filed on 07/26/2019 and claims benefit in provisional application 62/711,241
filed on 07/27/2018.
Claim Status
Claims 1-6, 8-10, 14-27, and 30-35 are pending and examined. Claims 1, 10, 14, 20, and 31 were amended. Claims 7, 11-13, 28, and 29 were canceled.
Withdrawn Claim Objections
Objections to claims 21 and 22 are withdrawn because claim 1 was amended by deleting “a second treated sample”.
Withdrawn Claim Rejections - 35 USC § 112
New matter rejections of claims 1-6, 8-10, 12-30, and 32-35 are withdrawn because rejections were obviated with claim amendments.
Indefiniteness rejections of claims 10, 20, and 31 are withdrawn because rejections were obviated with claim amendments.
Maintained Claim Objections
Claims 34 and 35 are objected because the first word in the claims does not start with a
capital letter. These objections are maintained because applicant did not amend the claims.
Maintained and New Claim Rejections - 35 USC § 112
Necessitated by Amendment
The following is a quotation of the first paragraph of 35 U.S.C. l 12(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.
Claim 31 is rejected under 35 U.S.C. l 12(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.
Claim 31 was amended to recite -OS(O)(O-)S and -S(O)(O-)S, which introduce new matter because these limitations are not supported in the application as filed. Paragraph 0018 provides support for -OS(O)(O-)S- and -S(O)(O-)S-. The amended chemical structures are each missing a negative charge on the second sulfur atom.
The following is a quotation of 35 U.S.C. l 12(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 1-6, 8-10, 14-27, and 30-35 are rejected under 35 U.S.C. l 12(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.
The following rejections are necessitated by amendment.
Claim 1 recites the limitation "the second treated sample" in the first wherein clause after the third step. There is insufficient antecedent basis for this limitation in the claim. This rejection is necessitated by amendment because previous step (iv) (current step (iii)) was amended by deleting “a second treated sample” and amending “the treated sample” to “the second treated sample”.
Claim 1 recites the limitation "the residual compound of Structure I" in the second wherein clause. There is insufficient antecedent basis for this limitation in the claim. This limitation is further indefinite because it is not clear if “residual” refers to a residual amount of the compound of Structure I or if it refers to a portion of the compound of Structure I that is left after some parts of the original compound of Structure I were removed.
Claim 1 recites the limitation "the treated media" in the third wherein clause. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the neutralizing agent" in the fourth wherein clause. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “by its treatment with a solid phase agent”, which renders the claim indefinite because it is not clear to what “its” is referring. Ground of rejection may be obviated by using the actual claim term instead of “its” and it is recommended to amend the claim to recite an active method step, such as “treating X with a solid phase agent” instead of the way it is written.
Claims 5, 6, 8-10, 14-27, and 30-35 are indefinite because the claims depend from an indefinite base claim.
New Claim Rejections -35 USC§ 103
Necessitated by Amendment
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.
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 CPR 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.
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.
Claims 1-5, 15-27, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable
over Tabatadze (US 2016/0289182 Al Published October 6, 2016).
The claims encompass a method comprising steps (i)-(iii) as described in the claims.
The teachings of Tabatadze are related to compositions and compounds for inactivating
one or more nucleic acid molecules, e.g. a DNA and/or RNA from a pathogen, in a sample. The
sample comprises blood or a blood product (Abstract). In one embodiment, the compound is of
structure (1):
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(paragraph 0009).
Paragraphs 0010-0012 provide definitions of variables Rl, R2, a, m, and n. The method
comprises administering the compound of structure I to a sample (paragraph 0027). In one
embodiment, the pathogen nucleic acid sequence is a viral or bacterial (paragraph 0034). In some
embodiments, the sample is a cosmetic composition, a medical composition, or the sample is
used for a vaccine or vaccine production (paragraph (036). The compositions and compounds
have a high affinity towards nucleic acid molecules. The compounds can penetrate through cell
membranes, cell walls, or caspids of organisms and pathogens. The compounds have chemically
active moieties that can inactivate nucleic acid molecules (paragraph 0047). Inactivating of
nucleic acids occurs by alkylating the nucleic acid (paragraph 0075). Alkylation of a nitrogenous
base can prevent replication of DNA, transcription of RNA, and/or translation of proteins that
can result in the inactivation of pathogens in a sample (paragraph (076). Examples of blood
borne pathogens include hepatitis B, among others (paragraph 0077). The compounds described
herein, or anti-pathogen compounds, can be used for the inactivation of one or more nucleic
acids in a donated blood sample. Figure 6 describes a schematic of a closed system enabling the
APC delivery and its removal from post-treatment blood (paragraph 099). A buffer is infused in
an APC containing pouch followed by infusion of a pH adjusted APC into leukodeplated blood
unit and incubated. Residual APC and products of its degradation are removed by a free flow
through disposable cartridge integrated into closed blood sterilization assembly (paragraph
0100). Chemical quenching of residual compositions and compounds having structure I in
posttreatment sample is possible when needed. Some or all of the compounds can be quenched
by using different nucleophilic small molecules. Such small molecules enable conversion of
aziridinyl groups into a neutral and/or non-toxic compounds, such as thiophosphates or
thiosulphates. Quenching can take place by direct infusion of the quencher compound dissolved
in water or water based solvent (paragraph 0103). The chemical quenching of aziridinyl rings is
shown in paragraph 0 104.
Regarding claim 1, it would have been prima facie obvious to a person of ordinary skill
in the art before the effective filing date of the claimed invention to have practiced a method of
inactivating a pathogen comprising treating a sample with a compound of formula
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, wherein R1 and R2 are all hydrogen atoms, a is 0-3, and m and n are, independently, 1-5; incubating for a time sufficient to
inactivate the pathogen, and treating the incubated sample with a neutralizing agent, with a
reasonable expectation of success because Tabatadze teaches a method of inactivating a
pathogen comprising treating a sample with a compound of formula
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, wherein R1 and R2 are all hydrogen atoms, a is 0-3, and m and n are, independently, 1-5; incubating for a sufficient time to
inactivate the pathogen, and treating the incubated sample with a neutralizing agent. The claimed
genus of compound having Structure I is obvious over the genus of prior art compound because
the two overlap in scope when in the claimed Structure I all Rl, R2, and R3 variables are a
hydrogen atom. The claimed variable n corresponds to the prior art n and m variables, and the
claimed variable is obvious because 3-5 overlaps with 1-5. The claimed variable m overlaps with
prior art variable a, and the claimed variable is obvious because 1-10 overlaps with 0-3.
It would have been further obvious to have removed residual APC and products of its degradation from the treated sample by free flow filtration through a disposable cartridge, with a reasonable expectation of success because Tabatadze teaches removing the residual APC and products of its degradation from the treated sample by free flow filtration through a cation exchange disposable cartridge comprising negatively charged beads. A disposable cartridge meets the limitation that requires a solid phase agent that is insoluble in the treated sample. It would have been reasonable to expect the residual APC and products of its degradation to be absorbed in the cartridge based on its description. The treated sample would have been removed from the solid phase agent once it flows out of the cartridge as filtered and purified sample.
Claims 2 and 3 are obvious because the genus of each of Structures IA and 1B overlaps in scope with the genus of prior art structure shown above, when in the claimed Structures IA and 1B all R2 and R3 variables are a hydrogen atom. The claimed variable a corresponds the prior art variables n and m. The claimed structure contains 1-3 repeating methylene units represented by "a" plus two additional methylene units, therefore the claimed structure contains from 3 to 5 repeating methylene units. The prior art contains from 1 to 5 methylene repeating units, which encompasses 3-5. The claimed variable b corresponds to the claimed variable "a". The claimed compound contains a unit that repeats b (0-6) number of times plus an additional repeating unit drawn in the structure. Thus, the unit that repeats b number of times is present in IA from 1 to 7. The claimed range of b is obvious because it overlaps with the range of "a" which is 0-3.
Regarding claims 4 and 5, it would have been obvious to have selected thiosulfate as the
neutralizing agent, with a reasonable expectation of success because Tabatadze teaches
thiosulfate as a suitable quencher compound that reacts with aziridinyl rings.
Claims 1, 21, and 22 require the concentration of the one or more neutralizing agents in
the treated sample to be up to 1 M, up to 100 mM, and up to 10 mM, respectively. Claims 26 and 27 require a pH of 6-8 and 6.7-8, respectively, when the sample of step (ii) is in contact with the one or more neutralizing agents. Claim 15 requires the one or more neutralizing agents to be in contact with the sample containing a residual amount of the compound having Structure I for a period from one minute to 48 hours, and at a temperature range of 0 to 100°C. Claims 34 and 35 define incubation time in step (ii) in the range of about 4 hours to 48 hours and about 6 hours, respectively. Tabatadze does not teach the duration of time, temperature, pH, and the concentration of the neutralizing agent during the quenching of aziridinyl compounds with the neutralizing agent. Tabatadze teaches that some or all of the compounds can be quenched by using nucleophilic molecules that enable conversion of aziridinyl groups into neutral and/or nontoxic compounds, such as thiophosphates or thiosulfates, where quenching can take place in a sample by direct infusion of the quencher compound dissolved in water or water based solvent. Tabatadze teaches quenching the aziridinyl with a thiophosphate, which is the same neutralizing agent as claimed. In view of these teachings, a person skilled in the art would have been capable of determining quencher concentration, duration of treatment, temperature and pH of the sample in order to quench some or all of the compounds that need to be quenched. The claimed ranges are obvious because a person skilled in the art would have arrived at the claimed conditions through routine experimentation. It is also noted that the claimed concentration, temperature, and duration ranges are broad, however the specification was reviewed and there is no evidence that the claimed ranges are critical. Considering that the prior art and claimed invention require quenching the same compound using the same neutralizing agent, it would have been reasonable to expect the skilled artisan to arrive at the same quenching conditions as claimed, absent evidence to the contrary.
Furthermore, the sample being treated with aziridinyl compound is blood, which has a
slightly alkaline pH of between 7 and 8. Tabatadze also teaches an embodiment in which the
aziridinyl compound is positively charge, which requires the compound to be in a medium
having a pH of about 6-8, and specifically 7.35 to about 7.45 (paragraph 0025 and 0070). In one
embodiment, the reaction takes place at a pH of about 6-8 (paragraph 0084). It would have been
obvious to have treated a blood sample having a pH of about 7.35 to about 7.45 in order to have
the aziridinyl compound in a positively charged form, with a reasonable expectation of success
because Tabatadze teaches that in some embodiments the reaction takes place at a pH of about 6-
8 and specifically teaches treating blood and also teaches using the aziridinyl compound in a
positively charged form which requires a pH of about 6-8 and specifically 7.35-7.45. The pH
would have been within the claimed ranges when treated blood is contacted with the neutralizing agent because the quenching takes place in a sample by direct infusion of the quencher compound dissolved in water or a water soluble solvent. Thus, the claimed pH ranges would have been obvious over the embodiment where treated blood is quenched.
Per MPEP 2144.05 "Generally, differences in concentration or temperature will not
support the patentability of subject matter encompassed by the prior art unless there is evidence
indicating such concentration or temperature is critical. "[W]here the general conditions of a
claim are disclosed in the prior art, it is not inventive to discover the optimum or workable
ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA
1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an
acid concentration between 25% and 70% was held to be prima facie obvious over a reference
process which differed from the claims only in that the reference process was performed at a
temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330,
65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already
generally known provides the motivation to determine where in a disclosed set of percentage
ranges is the optimum combination of percentages.").
Regarding claim 16, it would have been obvious to have neutralized all of the compounds, with a reasonable expectation of success because Tabatadze teaches quenching all
of the residual compounds having structure I in a post-treatment sample. The claimed range "at
least 2 logs" is obvious because the prior art teaches neutralizing all of the compounds.
Regarding claim 17, it would have been obvious to have treated blood having a pathogen
that causes hepatitis B in order to remove the pathogen, with a reasonable expectation of success
because Tabatadze teaches inactivating blood borne pathogens selected from pathogens that
cause hepatitis B and teaches treating blood with the method.
Regarding claims 18-20, it would have been obvious to have treated blood, with a
reasonable expectation of success because Tabatadze teaches that the method is useful for
treating blood.
Claims 23 and 24 are included in the rejection for the purpose of compact prosecution.
Compound X is interpreted as structure X in paragraph 0067 and Compound XIV is interpreted
as structure XIV in paragraph 0068. The compounds of structure X and XIV are obvious over
compound I of the prior art when Rl and R2 are methyl and each a is independently of each
occurrence 0, 1, 2, or 3; and each m and n are, independently, 1, 2, 3, 4, or 5 (paragraphs 0009-
0012).
Regarding claim 25, the "wherein" clause describes the intended effect of a method step
positively recited. It would have been reasonable to expect the prior art method to have the same
effect because the prior art method encompasses the same steps as claimed. See MPEP 2111.04.
Regarding claim 33, Tabatadze teaches an embodiment where a buffer is infused in an APC containing pouch followed by infusion of a pH adjusted APC into leukodepleted blood unit and incubated. Residual APC and products of its degradation are removed by a free flow through disposable cartridge integrated into closed blood sterilization assembly (paragraph 0100). Tabatadze further teaches chemically quenching compounds having the structure I in a post treatment sample using different nucleophilic molecules. Quenching can take place in a sample by direct infusion of the quencher compound dissolved in water (paragraph 0103). Therefore, by directly infusing the quencher compound dissolved in water into the sample held in a pouch, the quencher compound is located in the pouch. This embodiment meets the claimed limitations because the quencher compound is a neutralizing agent and a pouch is a bag.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tabatadze as applied to claims 1-5, 15-27, and 33-35 above, and further in view of Purmal (US 2002/0150950 Al, Published October 17, 2002).
The claims further define the method of claims 1 and 5.
The teachings of Purmal are related to methods of inactivating contaminants of a
biological matrix comprising (a) contacting a biological matrix with a inactivating agent
including an aziridino moiety, (b) contacting the product of step (a) with a solid support
including at least one quenching moiety attached to the solid support through covalent bonds,
under conditions and for a time sufficient to allow the unreacted agent to bond covalently to the
quenching moiety, and (c) separating the solid support and the unreacted agent from the
biological matrix where the unreacted agent is attached to the solid support through covalent
bonds (Abstract). Biological matrix includes whole mammalian blood (paragraph 0007). The
number of quenching moieties that can be attached to a support depends on the number of
functional groups on the surface of the support. The total number of quenching moieties also
depends on the number of quenching moieties attached to each functional group. For example, a
polymeric support may contain 2 mmol/g hydroxyl groups, each of these hydroxyl groups can
have as many as 150 thiophosphate groups attached to it (paragraph 0025). Thiophosphate
groups may be attached directly to the solid support or through a linker such as an ethylene liner
(paragraph (0026). A variety of materials can be used as the solid support. Examples include
polyacrylamide pads deposited on solid surfaces. The solid support may be in the form of
permeable or semi-permeable membranes. The solid support may be contained within a filtration
device such as a cartridge (paragraph 0028).
The teachings of Tabatadze and Purmal are related to methods of inactivating
contaminants in blood comprising combining a compound comprising an aziridinyl moiety with
blood in order to inactivate the contaminant, followed by adding a quencher, and separating the
blood from the reaction mixture, and it would have been obvious to have combined their
teachings because they are in the same field of endeavor.
Regarding claim 6, it would have been prima facie obvious to a person skilled in the art
to have modified the method of Tabatadze by replacing thiosulfate with sodium thiosulfate, with
a reasonable expectation of success because Purmal teaches that sodium thiosulfate is known as a
traditional quenching agent (paragraph 0037), and replacing one equivalent with another to
obtain predictable results supports obviousness.
Claims 8-10, 14, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Tabatadze as applied to claims 1-5, 15-27, and 33-35 above, and further in view of Wu (Journal of Environmental Science 19(2007) 1520-1527) as evidenced by BIO-RAD (Bio-Beads® S-X Beads Gel Permeation Chromatography Instruction Manual, pages 1-18, accessed from https://www.bio-rad.com/webroot/web/pdf/ps/literature/Bulletin_9142.pdf, accessed on May 25, 2026).
The claims further define the method of claim 1.
The teachings of Tabatadze are relied upon as summarized above, and Tabatadze does not teach a suitable negatively charged beads for cation exchange filtration.
The teachings of Wu are related to thiosulfonate functionalized polystyrene resin. Thiosulfonic anion was immobilized onto polystyrene beads and used as separation media (Abstract). Bio-Beads S-X2® obtained from Bio-Rad Laboratories were used as the starting polymer for synthesis (Experimental Section page 1520). Potassium polystyryl-thiosulfonate beads were prepared by functionalizing S-X2® polymer beads (Sections 1.2.2 and 1.2.3 on page 1521).
The teachings of Tabatadze and Wu are related to negatively charged beads used as separation media and it would have been obvious to have combined their teachings because they are in the same field of endeavor. It would have been prima facie obvious to a person of ordinary skill int the art before the effective filing date of the claimed invention to have selected thiosulfonate functionalized polystyrene resin beads and used as separation media in the filtration cartridge in Tabatadze, with a reasonable expectation of success because Tabatadze requires negatively charged beads in a cation exchange disposable cartridge and Wu teaches that thiosulfonate functionalized polystyrene beads are useful as separation media, and the selection of a known material based on its suitability for its intended purpose supports obviousness.
Claim 8 is obvious because thiosulfonate functionalized Bio-Beads S-X2® are porous and gel of organic polymer as evidenced by BIO RAD, which teaches Bio-Beads S-X beads are a series of porous divinylbenzene crosslinked polystyrene polymers used for gel permeation separation (page 1 Introduction and Technical Description).
Regarding claim 9, thiosulfonate functionalized polystyrene beads have negatively charged functional groups on the bead surface, which increase surface hydrophilicity and the skilled artisan would have expected the beads to be wettable in aqueous based media.
Regarding claim 10, Wu’s beads are made from polystyrene.
Regarding claim 14, Wu’s beads are made from divinylbenzene crosslinked polystyrene resin.
Regarding claims 30-32, Wu’s beads are functionalized with thiosulfonate groups, which react with the compound having Structure I.
Response to Arguments
Applicant’s arguments submitted in the remarks dated May 8, 2026 are not persuasive because current rejection relies on the teachings of Tabatadze to meet limitations that require the solid phase agent to absorb the products of neutralization or degradation. Tabatadze teaches a filtration cartridge that filters the sample by cation exchange using negatively charged beads. A cartridge comprising negatively charged beads performs as a separation medium by absorbing products of neutralization and degradation from the sample, which reads on a solid phase agent that absorbs the products of neutralization and degradation.
Conclusion
No claims are 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
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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