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 .
Priority
This application filed 05/16/2023 is a National Stage entry of PCT/IL2021/051368, international filing date: 11/17/2021. PCT/IL2021/051368 claims priority from provisional application 63114556, filed 11/17/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 16, 2023 and June 10, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
The amendments and arguments filed on 06/10/2026 are acknowledged and have been fully
considered. Claims 1-49 are cancelled. Claim 50, is currently amended. Claims 50-69
are now pending and will be examined on the merits herein.
Objections/Rejections Withdrawn
Objections and/or rejections not reiterated from previous Office Action are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied, and constitute the
complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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 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.
Claims 50-52, 66-69 are rejected under 35 U.S.C. 103 as being unpatentable over Gilon, Chaim hereinafter Gilon (WO2019/175867A1; published 19 September 2019; reference provided in the IDS) in view of Jonathan M. Collins, hereinafter Collins (WO2017/070512A1; published 27 April 2017) further in view of Shen Wang et al., hereinafter Wang (Shen Wang et al., Chemical Engineering Science, Vol. 46, No. 9, pp. 2373-2376, 1991).
Claims 50-52, 66, 67, 69 are directed to a method of solid phase peptide synthesis in a reaction chamber, comprising a stirring apparatus having at least two blades, a reaction mixture of functionalized polymeric resin beads, at least one solvent, at least one reactant, in contact with the blades and achieving rotational rates of at least 600 rpm, shear rate of at least 3-103 sec-1, wherein the reaction chamber is heated to allow the temperature range of 40 °C-100 °C, in the range of 50 °C-100 °C, thereby performing at least one cycle of solid phase peptide synthesis.
Gilon teaches solid phase peptide synthesis, the method comprises the steps: providing a reactor comprising a reaction chamber and a stirring apparatus comprising an impeller having at least two blades rotatable about an axis; inserting beads of functionalized polymeric resin and at least one solvent into the reactor to provide a reaction mixture, wherein the reaction mixture is in contact with the rotatable blades; inserting at least one protected monomeric organic molecule and at least one coupling agent into the reaction chamber and spinning the impeller, thereby forming a coupling product of the protected monomeric organic molecule and the resin; washing excess of said protected monomeric organic molecule; and; inserting at least one deprotecting reagent into the reaction chamber and spinning the impeller, thereby removing at least one protecting group from the coupling product, forming a coupling product of the deprotected monomeric organic molecule and the resin, thereby completing a cycle in the solid phase synthesis of a polymeric organic molecule; and spinning the impeller for a period of time, at a rotational rate of at least 600 rounds per minute, while maintaining a sheer rate of at least 3-103 sec-1, thereby performing at least one step of the solid phase synthesis (see page 6; lines 1-8). Gilon teaches a coupling capacity of 0.2 – 0.6 mmol/g (see claim 15 and claim 19). Gilon teaches that solid phase synthesis method is for synthesis of polymeric organic molecules selected from the group consisting of peptide…glycoproteins and proteoglycans (see page 12; line 23 and page 13; lines 1-14). Gilon teaches that methods to improve the technique of solid phase peptide synthesis (SPSS) include thermal methods e.g. microwave and heating (see page 3, line 9).
Gilon does not teach heating the reaction chamber to 40 °C – 100 °C and 50 °C - 100 °C.
Collins teaches improvements in solid phase synthesis of peptides (SPSS), wherein heating the vessel contents to between about 81 °C – 99 °C accelerates the deprotection step of peptide synthesis (see claims 14, 17; [0044]). Colin teaches that the deprotection step can be carried out by heating the compositions to at least about 60 °C and in some cases to between about 81 °C - 99 °C [0045]. Since Collins discloses a temperature range which touches or overlaps the claimed range, the rejection is based on 35 U.S.C. 103 which takes differences into account." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims to titanium (Ti) alloy with 0.8% nickel (Ni) and 0.3% molybdenum (Mo) were not anticipated by, although they were held obvious over, a graph in a Russian article on Ti-Mo-Ni alloys in which the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni). See MPEP § 2131.03 (III).
Gilon and Collins do not teach a period of time of no more than 120 seconds.
Wang teaches that reactor temperature can be a significant factor in controlling coupling rates (see Conclusion, page 2373). Notably, Wang teaches that the enhancement of the reaction rate with increasing temperature is evident (see page 2374, 3rd paragraph; see Fig 1).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gilon, by heating the reaction as in the instant application. One motivated to do so would have a reasonable expectation of success as Gilon explicitly teaches heating to improve the technique of solid phase peptide synthesis (see page 3, line 9) and as suggested in Wang, increasing temperature enhances reaction rate. Thus, one would have recognized that applying the teaching of Collins and Wang to the method of Gilon would have yielded predictable results and improved the technique of SPSS (See MPEP § 2143 I(A)(D)).
Claims 50, 53-65 are rejected under 35 U.S.C. 103 as being unpatentable over Gilon, Chaim hereinafter Gilon (WO2019/175867A1; published 19 September 2019; reference provided in the IDS) in view of Jonathan M. Collins, hereinafter Collins (WO2017/070512A1; published 27 April 2017) further in view of Mark Simon et al., hereinafter Simon (US2018/0057525A1; published 1 March 2018; reference provided in the IDS) further in view of Shen Wang et al., hereinafter Wang (Shen Wang et al., Chemical Engineering Science, Vol. 46, No. 9, pp. 2373-2376, 1991).
The teachings of Gilon, Colin and Wang have been set forth above.
Additionally, claims 53-55 are directed to a heating assembly in contact with the external enclosure of the reaction chamber. Embodiments of the specification disclose heating assembly is a circulating fluid bath ([0021], line 24).
Claims 56-58 and 60 are directed to a semipermeable glass fritted disc in the internal cavity.
Claims 59, 61-65 are directed to the reactor further comprising a proximal conduit end wherein the proximal conduit end is connected to a portion of the enclosure. The proximal conduit end is connected to a first distal conduit end and to a second distal conduit end wherein the first distal conduit end is connected to an inert gas source, wherein the second distal conduit end is connected directly or indirectly to a vacuum pump, wherein the reactor further comprises a three-way valve configured to monitor flow of liquids and gases.
As noted above, Gilon teaches solid phase peptide synthesis in a reaction chamber and stirring apparatus wherein the stirring apparatus comprises an impeller having at least two blades with a rotational rate of at least 600 rounds per minute, shear rate of at least 3-103 sec-1 (see page 6; lines 1-8).
Gilon does not teach heating the reaction chamber to 40 °C – 100 °C and 50 °C - 100 °C. Gilon does not teach a glass frit for draining liquids from the reaction vessel and vacuum or inert gas in SPSS.
Collins teaches improvements in solid phase synthesis of peptides wherein heating the vessel contents to between about 81 °C – 99 °C accelerates the deprotection step of peptide synthesis (see claims 14, 17; [0044]). Colin teaches that the deprotection step can be carried out by heating the compositions to at least about 60 °C and in some cases to between about 81 °C - 99 °C [0045]. Collins teaches microwave radiation to heat the deprotection step (claim 15). Microwave source (diode) heats the reaction vessel (see Figure 6 and 7). Colin teaches a vacuum source connected to the reaction vessel [0018]. Colins teaches that deprotection step is accelerated further by pulling the vacuum while heating the vessel contents [0044]. Colin teaches that in Fig 7, the vessel 22 includes a frit 52 (typically made of glass). The frit 52 permits liquids to be drained from the reaction vessel 22. Colin teaches that in Fig 7, the spray head 53 delivers compositions to the reaction vessel 22. Notably, other equivalent fixtures can be selected by the skilled person without undue experimentation. In particular, Fig 7 illustrates a nitrogen supply 54 which is connected to a plurality of supply bottles 55 which are illustrated as Erlenmeyer flasks [0053]. Collins teaches that nitrogen pressure transfers all reagents in the reaction vessel and provides an inert environment during synthesis [0062]. Collins teaches that Nitrogen is helpful because it is relatively inexpensive but other inert gases, including noble gases can be used for this purpose [0054]. Collins teaches that in Figure 6, the nitrogen supply and the metered loop can connect to the processor 47 so that the processor 47 can control the manner in which the compositions are dispensed from the vessels 55 to the reaction vessel 52. Collins teaches that the schematic line connections (64 and 65) are in practice, a combination of tubes (pipes), valves, and controls for those lines; e.g., in practice line 64 represents a connection between a valve or manifold in line 58, a controller for that line, and the processor 47. The same relationships hold true for the line 65 between the nitrogen supply 54 and the processor 47. Collins teaches that the reaction vessel system utilizes up to 25 stock solutions for amino acids and seven reagent ports that can perform the following functions: main wash, secondary wash, deprotection, capping, activator, activator base, and cleavage. The system uses nitrogen pressure for transfer of all reagents and to provide an inert environment during synthesis. The system uses metered sample loops for precise delivery of all solutions [0062].
Collins does not teach a fluid bath or heating jacket for heating the reaction vessel.
Simon teaches achieving fast peptide synthesis time by heating [0063]. Simon teaches that any suitable method of heating may be used to increase the temperature of the contents. For example, heating zone may comprise a liquid bath (e.g. water bath), a resistive heater, a gas-convection-based heating element or any other suitable heater [0065]. Simon teaches that the reactor immersed in a temperature-controlled bath, allows reagents to be heated in a consistent and controlled manner immediately before reaching the resin bed [0095].
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to modify the method of Gilon, by using a glass frit as in the instant application. Gilon teaches that resin beads can fracture into smaller and smaller particles which can clog filters and interrupt the synthesis process (see page 3, line 24). Additionally, Gilon teaches that heating improves the technique of solid phase peptide synthesis (see page 3, line 9). Although Gilon uses the method of microwave-mediated heating, Simon teaches that the reactor immersed in a temperature-controlled bath, allows reagents to be heated in a consistent and controlled manner immediately before reaching the resin bed [0095]. Thus, one would have recognized that applying the teaching of Collins and Simon to the method of Gilon would have yielded predictable results and improved and accelerated the technique of SPSS (See MPEP § 2143 I(A)(D)).
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 50-69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US11267846B2 in view of Jonathan M. Collins, hereinafter Collins (WO2017/070512A1; published 27 April 2017) further in view of Mark Simon et al., hereinafter Simon (US2018/0057525A1; published 1 March 2018; reference provided in the IDS) further in view of Shen Wang et al., hereinafter Wang (Shen Wang et al., Chemical Engineering Science, Vol. 46, No. 9, pp. 2373-2376, 1991).
The teachings of Collins, Simon and Wang have been set forth above.
Regarding claims 50-52, 66-69 reference patent ‘846 teaches the method for performing at least one cycle of solid phase peptide synthesis.
Reference patent does not teach temperature range of 40°C to 100°C and time of no more than 120 seconds.
The combined teachings of Collins and Wang teach the recited temperature range and Wang teaches that reactor temperature is a significant factor in controlling coupling rates. Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of reference patent ‘846, by heating the reaction as in the instant application. One motivated to do so would have a reasonable expectation of success as the reference patent ‘846 explicitly teaches the method of solid phase peptide synthesis (see page 3, line 9) and as suggested in Wang, increasing temperature enhances reaction rate. Thus, one would have recognized that applying the teaching of Collins and Wang to the method of reference patent ‘846 would have yielded predictable results and improved the technique of SPSS (See MPEP § 2143 I(A)(D)).
Regarding claims 50, 53-65, reference patent ‘846 does not teach glass frit and vacuum or inert gas.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of the reference patent ‘846, by using a glass frit and inert nitrogen gas as in the instant application, by combining the teachings of Collins, Simon and Wang. Simon teaches that the reactor immersed in a temperature-controlled bath, allows reagents to be heated in a consistent and controlled manner immediately before reaching the resin bed [0095]. Thus, one would have recognized that applying the teaching of Collins and Simon to the method of the reference patent ‘846 would have yielded predictable results and improved and accelerated the technique of SPSS (See MPEP § 2143 I(A)(D)).
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Applicant argues that neither Gilon nor Collins teaches, suggests or renders obvious the defined combination of (i) high shear mechanical stirring, (ii) elevated temperature, and (iii) a short reaction time range of not more than 120 seconds. Examiner would like to remind the Applicant that the rejection of record was that it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings in Gilon, Collins and Wang. One would have been motivated to do so with a reasonable expectation of success, as all references combined, are directed to the steps in solid phase peptide synthesis and disclose the role of reaction temperature on reaction rate. The combined prior art, i.e. Gilon, Collins and Wang, teach solid phase peptide synthesis in a reaction chamber and stirring apparatus, wherein the stirring apparatus comprises an impeller having at least two blades with a rotational rate of at least 600 rounds per minute and shear rate of at least 3-103 sec-1 (Gilon -see page 6; lines 1-8). Collins specifically teaches improvements in solid phase synthesis of peptides (SPSS), wherein heating the vessel contents to between about 81 °C – 99 °C accelerates the deprotection step of peptide synthesis (see claims 14, 17; [0044]) and Wang discloses that enhancement of reaction rate with increasing temperature is evident (Wang -see page 2374, 3rd paragraph; see Fig 1).
Applicant argues that the present invention represents a paradigm shift in SPSS and the dramatically reduced time ranges is not routine acceleration of known processes. Applicant argues that the high-shear mechanical stirring in the present methods promotes rapid convective heat transfer and efficient temperature homogenization throughout the entire reaction volume. The synergistic interaction between heating and high-shear stirring distinguishes the claimed methods. The Examiner would like to remind the Applicant that the burden is on the Applicant to establish results are unexpected and significant. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
“[E]evidence of unexpected results must be weighed against evidence supporting prima
facie obviousness in making a final determination of the obviousness of the claimed invention. In re
May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). Where the unexpected properties of a claimed
invention are not shown to have a significance equal to or greater than the expected properties, the
evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re
Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977). Expected beneficial results are evidence of
obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof. "In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) (resultant decrease of dental
enamel solubility accomplished by adding an acidic buffering agent to a fluoride containing dentifrice
was expected based on the teaching of the prior art); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. &
Inter. 1989).
Applicant argues that working examples demonstrate coupling and deprotection steps are completed in 10-30 seconds even for challenging peptides and these outcomes directly contradict conventional assumptions in the field and would not have been reasonably expected by a person of ordinary skill in the art. The rejection of record was that it would be obvious to a person of ordinary
skill in the art before the effective filing date of the claimed invention to combine reaction conditions in the teachings of the prior art references, to generate the claimed method of solid phase peptide synthesis.
Applicant argues that the observed results are synergistic and non-linear -substantial reduction in reaction time is far greater that what would be predicted from heating alone or mixing alone. Examiner would like to remind the Applicant that the specific teachings in the combined prior art, would render obvious to a person of ordinary skill in the art, with a reasonable expectation of success, to perform the recited steps in solid phase peptide synthesis and to arrive at the observed results.
Applicant argues that Collins reinforces the conventional expectation that mechanical stress on resin beads should be avoided, particularly when operating at elevated temperature, thus, teaching away from high shear mechanical stirring. Examiner acknowledges Exhibits 1-3. Examiner reminds the Applicant that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicant argues that Simon fails to cure the deficiencies of Gilon and Collins and the combination of Gilon, Collins and Simon therefore rely on extracting isolated heating apparatus features from Simon and retrofitting them into fundamentally different process regimes. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). One motivated to combine Collins, Gilon, Simon and Wang, would have a reasonable expectation of success, as Simon teaches achieving fast peptide synthesis time by heating [0063] and the teachings in Wang, Simon and Collins specifically disclose enhancement of reaction rate with increasing temperature (Wang -see page 2374, 3rd paragraph; see Fig 1).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/ Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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