DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114
Applicant’s submission filed on 16 February 2026 has been entered, and the arguments presented therein have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112(a) – New Matter
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 32-49 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.
Claim 32 is a new claim which recites that the composition is able to retain chemical stability of the antibody for at least 4 weeks at 5°C. There does not appear to be adequate support for this newly added claim limitation for at least the following reasons.
As an initial matter, the instant specification discloses the following on page 6, relevant text reproduced below.
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Figure 3G appears to relate to 4 weeks at 5°C and is reproduced below.
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The examiner notes that only the right-most column appears to potentially relate to the claimed invention because only this column is drawn to histidine buffer, whereas the other formulations have a citrate buffer instead of a histidine buffer. Also, it is further unclear whether this composition comprises a monosaccharide or disaccharide and polysorbate at the required concentration. Furthermore, it is unclear as to whether the disclosed formulation can actually be considered to be are able to retain chemical stability of the antibody for at least 4 weeks at 5°C, as the disclosed composition comprising histidine buffer has 3.09% aggregates after the storage period and it is unclear whether this is a sufficiently low percentage of aggregates to be considered chemically stable. As such, there does not appear to be sufficient evidence that the data presented in the original disclosure adequately supports the claimed subject matter. Similar issues appear to be applicable to newly added claims 43-45 and 48-49.
Furthermore, even if, purely en arguendo, the right-most formulation of the above-reproduced table is understood to have been chemically stable, this still appears to be insufficient to adequately support the full scope of the claims. The inclusion of a generic disclosure (e.g. an antibody formulation comprising polysorbate 20, sucrose, and histidine in the recited concentration ranges with a pH with the required range) as well as a species (e.g. the composition of the right-most column of the above-reproduced table) is not sufficient to provide support to a subgenus (e.g. the claimed invention, which is an antibody formulation comprising polysorbate 20, sucrose, and histidine in the recited concentration ranges with a pH with the required range and also comprising the required stability). See MPEP 2163.05(II), third paragraph in section.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 32-49 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 32 recites “wherein the formulation is able to retain chemical stability.” It is unclear how the phrase “chemical stability” further limits the claim. The examiner presents the following rationale in support of this position.
The instant specification appears to define the term “stable” in the paragraph bridging pages 9-10 of the instant specification. The portion of that paragraph from page 9 has been reproduced below.
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As such, the specification indicates that there are multiple methods of measuring stability. Therefore, it is unclear if an antibody formulation that is found to be stable using one of the above-indicated techniques but is not found to be stable using a different technique would meet the claimed requirements.
For the purposes of examination under prior art, the examiner understands that stability as measured by any technique meets the claimed requirements, even if a different technique were to result in the formulation being found to be unstable. Additionally, a prior art teaching that a composition is stable will be understood to meet the claimed requirements.
Claims 43, 45, and 48 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.
The claims rejected here recite a dynamic light scattering intensity measured as 11.1 nm. It is unclear how this limitation further limits the claim scope because 11.1 nm is a measure of either particle size or wavelength, not intensity. As such, it is unclear if the additional limitation of these claims limits the particle size, a particular electromagnetic radiation wavelength, or something else. Therefore, it is unclear what is being limited by these claims.
For the purposes of examination under prior art, the examiner understands the additional limitations of these claims to refer to particle size.
Claims 48 is 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 48 recites a dynamic light scattering intensity of the composition of claim 46 after storage under particular conditions. It is unclear whether claim 48 is drawn to the dynamic light scattering intensity of a solid, lyophilized composition, or of a liquid composition that has been lyophilized and subsequently reconstituted. The examiner presents the following arguments in support of this position.
Claim 48 depends upon claim 46. Claim 46 recites a lyophilized pharmaceutical formulation. The skilled artisan would have understood a lyophilized pharmaceutical formulation to have been solid. However, as best understood by the examiner, dynamic light scattering measures diffusion coefficient, as of Stetefeld et al. (Biophysical Review, Vol. 8, 2016, pages 409-427), as of the abstract and introduction on page 409. This diffusion would have occurred in the case of solid particles dispersed in liquid; this is taught at least as of Kuhner et al. (US 2010/0233060 A1), paragraph 0044, which teaches using dynamic light scattering on particles in toluene, wherein toluene is a liquid. As such, the examiner’s search would appear to indicate that dynamic light scattering is performed on particles or macromolecules suspended in liquid rather than particles or macromolecules in a dry solid form.
In view of this, it is unclear whether claim 48 further limits the dynamic light scattering of a solid composition, which is what the lyophilized composition of claim 46 is understood to be, or of a liquid composition formed after reconstitution of the lyophilized composition.
For the purposes of examination under prior art, the examiner will examine claim 48 as if it has the same scope as claim 46 upon which it depends, given the lack of clarity of the additional limitations of claim 48.
Claim Interpretation – Lyophilized vs. Liquid Formulation
Claim 32 requires that the stable liquid formulation is able to retain chemical stability of the antibody for a particular period of time. Claims 46-49 recite a lyophilized formulation which is made from freeze-drying the composition of claim 32. The skilled artisan would have understood the term “lyophilized” to have referred to a solid composition that has been prepared by freeze-drying. The skilled artisan would have understood that the limitation regarding stability would have applied only to the liquid formulation, and not to the solid, lyophilized formulation of claim 46. As such, claim 46 is understood to be a separate independent claim as compared with claim 32.
Claim Rejections - 35 USC § 103 – Obviousness
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 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 32-46 and 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endell et al. (US 2015/0238603 A1) in view of Andya et al. (US 2006/0088523 A1) and Bowen et al. (US 2012/0034212 A1).
Endell et al. (hereafter referred to as Endell) is drawn to an anti-CD38 antibody, as of Endell, title and abstract. Endell teaches the following sequence, as of page 8 of the reference, which is reproduced below.
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This sequence appears to read on sequence ID #7. Endell also teaches the following, as of pages 8-9, relevant text reproduced below.
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Endell does not teach the required excipients and is silent as to a lyophilized formulation and is silent as to the required stability.
Andya et al. (hereafter referred to as Andya) is drawn to antibody formulations stabilized in histidine buffer, as of Andya, title and abstract. Andya teaches the following formulation, as of paragraph 0045, reproduced below.
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Andya teaches that this formulation results in physical and chemical stability, as of Andya, paragraph 0092.
Andya does not teach the required antibody.
It would have been prima facie obvious for one of ordinary skill in the art to have used the buffer of Andya to have stored the antibody of Endell. Endell is drawn to the protein structure of a particular antibody, but is silent as to the conditions under which the antibody is stored. Andya teaches a buffer which may be used for storage of antibodies. As such, the skilled artisan would have been motivated to have used the buffer of Andya to have predictably stored the antibody of Endell to have predictably stabilized the antibody of Endell with a reasonable expectation of success.
Andya differs from the claimed invention because Andya does not teach the histidine concentration.
Bowen et al. (hereafter referred to as Bowen) is drawn to an antibody, as of Bowen, title and abstract. Bowen teaches information regarding the storage conditions of the antibodies, as of paragraph 0037. This paragraph appears to teach sucrose at concentrations of up to 40%, polysorbates (including polysorbate 20) at concentrations of 0.001% to 2%, and buffers such as histidine at concentrations between about 10 mM and about 400 mM. Bowen teaches that this results in stability, as of at least paragraph 0407 of Bowen.
Bowen does not teach the required antibody.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the concentrations of polysorbate 20, sucrose, and histidine, as taught by Andya, in the manner taught by Bowen. Andya is drawn to a formulation for storing an antibody comprising polysorbate 20, sucrose, and histidine. Bowen also teaches these ingredients for storing an antibody, and teaches a wide range of concentrations at which these ingredients can be present and result in a stable antibody. As such, the skilled artisan would have been motivated to have modified the composition of Andya in the manner taught by Bowen in order to have predictably stabilized an antibody with a reasonable expectation of success.
As to claim 32, the claim requires Seq ID No. 7. This is taught by Endell.
As to claim 32, the claim requires Seq ID. No. 8. This is taught by Endell.
As to claim 32, the claim requires polysorbate in a concentration of 0.1% to 0.2%. Andya teaches polysorbate 20 at a concentration of about 0.01% to 0.1%, as of paragraph 0045 of Andya. This overlaps with the claimed range at the end point of 0.1%. Additionally, Bowen teaches an amount from 0.001% to 2% of a polysorbate, which also overlaps with the claimed range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 32, the claim requires 150 mM to 350 mM sucrose. Andya teaches 60 mM to 250 mM sucrose, as of paragraph 0045 of Andya. This overlaps with the claimed range of claim 32. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). For the portion of the range of claim 32 that is not overlapped by Andya, the examiner notes that the skilled artisan would have been motivated to have increased the concentration of sucrose in view of the teachings of Bowen, paragraph 0037, which teaches higher concentrations of sucrose. Generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, there does not appear to be evidence of criticality. Additionally, where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of an antibody storage solution comprising polysorbate 20, histidine buffer, and sucrose has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable sucrose concentration via routine experimentation.
As to claim 32, the claim requires 5 mM to 15 mM histidine buffer. Andya teaches histidine buffer in paragraph 0045, but appears to be silent regarding its concentration. Bowen teaches an amino acid buffer, which may be histidine buffer, in a concentration of between about 10 mM and about 400 mM, as of paragraph 0037 of Bowen. This overlaps with the claimed requirements. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 32, the claim requires a pH of between 5.5 and 6.5. Andya teaches this in paragraph 0045.
As to claim 32, the claim requires that the composition retain chemical stability of the antibody upon storage for at least 4 weeks at 5°C. Andya teaches the following as of paragraph 0092, relevant portion of the paragraph reproduced below.
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This appears to indicate 3 month (i.e. 12-13 week) stability at about 5°C, which is more than the required 4 weeks at 5°C. Bowen teaches the following, as of paragraph 0407, reproduced below.
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As such, the teachings of both Andya and Bowen indicate stability for at least 4 weeks at 5°C.
As to claim 33, Andya, paragraph 0045, part (a), teaches an antibody concentration of about 10 mg/mL to about 250 mg/mL. This overlaps with the required concentration. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 34, Andya teaches 0.1% polysorbate 20 as of part (d) of paragraph 0045.
As to claim 35, Bowen teaches amino acid buffer, that may be histidine buffer, at a minimum of 10 mg/mL, as of Bowen, paragraph 0037.
As to claim 36, Andya appears to teach a maximum sucrose concentration of 250 mM in paragraph 0045. This is slightly lower than the claimed concentration of 260 mM. Nevertheless, the skilled artisan would have been motivated to have optimized the concentration of sucrose in view of the teachings of Bowen. See the rejection of claim 32 above, especially the rationale under MPEP 2144.05(II)(A) that the examiner relied upon for addressing the sucrose buffer concentration.
As to claim 37, Bowen teaches amino acid buffer, that may be histidine buffer, at a minimum of 10 mg/mL, as of Bowen, paragraph 0037.
As to claim 38, Bowen teaches amino acid buffer, that may be histidine buffer, at a minimum of 10 mg/mL, as of Bowen, paragraph 0037.
As to claim 39, this claim is rejected for essentially the same reason that claim 36 is rejected.
As to claim 40, this claim is rejected for essentially the same reason that claim 36 is rejected.
As to claim 41, this claim is rejected for essentially the same reason that claims 34, 35, and 36 are rejected.
As to claim 42, Andya, paragraph 0045, part (a), teaches an antibody concentration of about 10 mg/mL to about 250 mg/mL. This overlaps with the required concentration. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 43, this claim appears to recite dynamic light scattering to measure stability. While neither Andya nor Bowen appear to measure stability in this manner (the examiner notes that Bowen uses static light scattering rather than dynamic light scattering), Andya and Bowen both teach stability for well over 4 weeks at 5°C. As such, there would have been a reasonable expectation that the composition of the combination of references would have had a dynamic light scattering in the claimed range even if this property was not measured because of the teachings of Andya and Bowen regarding stability. The PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same. See MPEP 2112(V). In this case, that Andya and Bowen both teach stability for well over 4 weeks at 5°C is sufficient evidence to shift the burden to applicant in accordance with the guidance provided by MPEP 2112(V).
As to claim 44, Bowen teaches the following, as of paragraph 0405, reproduced below.
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While Bowen does not appear to teach the relative humidity in this case, there would have been a reasonable expectation that the composition of the prior art would have been stable at 40°C with the recited relative humidity.
As to claim 45, this claim appears to recite dynamic light scattering to measure stability. While neither Andya nor Bowen appear to measure stability in this manner, (the examiner notes that Bowen uses static light scattering rather than dynamic light scattering) Andya and Bowen both teach stability for well over 4 weeks at 5°C. As such, there would have been a reasonable expectation that the composition of the combination of references would have had a dynamic light scattering in the claimed range even if this property was not measured because of the teachings of Andya and Bowen regarding stability. The PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same. See MPEP 2112(V). In this case, that Andya and Bowen both teach stability for well over 4 weeks at 5°C is sufficient evidence to shift the burden to applicant in accordance with the guidance provided by MPEP 2112(V).
As to claim 46, Bowen teaches a lyophilized formulation at least as of paragraph 0377. Regarding the teachings of Andya, the examiner notes that Andya teaches the following, as of paragraph 0374, reproduced below.
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This is not teaching away from lyophilization. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use. See MPEP 2123(II).
As to claims 48, this claim is rejected for the same reason that claim 46 is rejected. See the above rejection under 35 U.S.C. 112(b).
As to claim 49, this claim is rejected for the same reason that claim 44 is rejected.
Claim(s) 46-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endell et al. (US 2015/0238603 A1) in view of Andya et al. (US 2006/0088523 A1) and Bowen et al. (US 2012/0034212 A1), the combination further in view of Chang (Chang, Byeong S., Michael Reilly, and Hana Chang. "Lyophilized biologics." Lyophilized biologics and vaccines: modality-based approaches (2015): 1-401).
Endell is drawn to a particular antibody. Andya and Bowen are drawn to solutions for storing antibodies in liquid form. See the above rejection over Endell in view of Andya and Bowen.
For the purposes of this rejection, the examiner understands, purely en arguendo and in regard to this ground of rejection only, that Andya fails to teach that the composition is lyophilized.
Chang is drawn to lyophilized biologics including antibodies and teaches the advantages of lyophilized antibodies have superior stability during transportation and storage [Pg. 102, Paragraph 5, Ln. 1-5] and the lyophilization of a therapeutic antibody [Pg. 26, Table 1, Ln. 1].
Chang does not teach anti-CD38 antibodies.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the composition of Endell in view of Andya and Bowen to have been lyophilized. Endell is drawn to an antibody composition, and Andya and Bowen are drawn to solutions for storing antibodies. Chang teaches that lyophilization results in superior stability during transportation and storage. As such, the skilled artisan would have been motivated to have lyophilized the antibody composition of Endell in view of Andya and Bowen to have predictably increased storage stability with a reasonable expectation of success.
As to claim 46, Chang teaches lyophilization.
As to claim 47, Chang teaches less than 1% moisture as of page 68, bottom paragraph. This overlaps with the claimed requirements. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claims 48-49, these claims are rejected for the same reason as applied above regarding Endell in view of Andya and Bowen.
Response to Arguments
Applicant has provided arguments in applicant’s response on 16 February 2026 (hereafter referred to as applicant’s response). These arguments are addressed below.
In applicant’s arguments, page 5, applicant takes the following position.
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This argument references the decision by the Patent Trial and Appeal Board (PTAB) added to the file record on 17 December 2025, but does not point to a specific page or paragraph of the decision. Looking to the board decision, it appears that the relevant portion of the decision is on page 4, second to last paragraph, relevant text reproduced below.
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Other statements to this effect were made on page 5, which is reproduced below.
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As best understood by the examiner, this statement appears to take the position that applicant made arguments related to the alleged instability of the prior art despite the fact that the stability was not recited by the claims. As such, this appears to be a position that arguments related to antibody stability were not considered by the Board because said arguments related to unclaimed limitations. It is not a position that any particular claim limitation regarding stability would have rendered the claims allowable if amended into the claim. As such, nothing in the board decision on 17 December 2025 would appear to go against the currently applied rejection.
Additional Relevant Prior Art
As an additional relevant reference, the examiner cites Hu et al. (US 2019/0040137 A1), which was effectively filed prior to the effective filing date of the instant application. Hu et al. (hereafter referred to as Hu) is drawn to a stable antibody formulation comprising an anti-PD-1 antibody. The buffer in which the antibody is stored may comprise histidine, as of Hu, paragraph 0011, a pH of about 6, as of Hu, paragraph 0010, polysorbate 20, as of Hu, paragraph 0013, and sucrose, as of Hu, paragraph 0014.
Hu is not anticipatory for the following reasons. First, the antibody of Hu differs from the claimed antibody. Secondly, Hu teaches sucrose concentration in terms of percentage rather than molarity; as such, it is unclear whether the sucrose concentration of Hu reads on the claimed concentration. Third, most of the examples of Hu include polysorbate 80 rather than polysorbate 20. Fourth, while Hu does teach an example comprising histidine and polysorbate 20 as of Hu, table 3 spanning pages 16-17, that example does not appear to comprise sucrose.
In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03. For the reasons set forth above, Hu is understood to be just as good as, but no better than Andya et al. (US 2006/0088523 A1) and Bowen et al. (US 2012/0034212 A1), which were cited above. As such, the examiner has not separately rejected the claims as obvious over Hu as that would appear to be effectively duplicative of the above-applied rejections.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612