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 .
Summary
Claims 1-4, 7-12, and 14-24 are pending in this office action. Claims 23 and 24 are new. Claims 5-6 and 13 are cancelled. All pending claims are under examination in this application.
Priority
The current application filed on October 17, 2022 is a 371 of PCT/GB2021/050913 filed April 16, 2021. The current application claims foreign priority to GB2005593.5 filed April 17, 2020.
Information Disclosure Statement
Receipt of the Information Disclosure Statement on June 5, 2025 is acknowledged. A copy of the document is attached to this office action.
Claim Rejections - 35 USC § 112
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.
Claim 3 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 3 recites the limitation "the biologically-active agent" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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 non-obviousness.
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.
Claims 1-4, 7-12, and 14-24 are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson et al. (WO2014/187995A1) in view of Edelson et al. (US2016/0213757A1) and Job et al. (WO2013/131159A1 and BR102012005278A2).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims. The full English translation of BR102012005278A2, which is in the same patent family of WO2013/131159A1, is attached to this office action. BR102012005278A2 is NOT newly cited art, it is a newly-available translation of the equivalent of WO2013/131159A1]
1. Carlsson et al.
Carlsson et al. is considered to be the prior art closest to the present application and teaches a solid nanoparticle with inorganic coating (see title). Furthermore, Carlsson et al. disclose a nanoparticle having a solid core comprising a biologically active substance, said core being enclosed by an inorganic coating, a method for preparing the nanoparticle, and the use of the nanoparticle in therapy. A kit comprising the nanoparticle and a pharmaceutical composition comprising the nanoparticle (see abstract).
2. Edelson et al.
Edelson et al. teach dermal delivery (see title). Additionally, Edelson et al. disclose systems and methods for treating disorders and/or conditions associated with the dermal level of the skin. Such disorders include acne, hyperhidrosis, bromhidrosis, chromhidrosis, rosacea, hair loss, dermal infection, and/or actinic keratosis. Methods generally involve administering nanoemulsions (e. g., nanoparticle compositions) comprising at least one therapeutic agent, such as botulinum toxin. In some embodiments, nanoemulsions are prepared, e. g., by high pressure microfluidization, and comprise a particle size distribution exclusively between 10 nm and 300 nm (see abstract).
3. Job et al.
Job et al. teach method for producing functional nanocomposites made of paramagnetic nanoparticles and thus obtained functional nanocomposites (see title). Also, Job et al. disclose a method for producing functional nanocomposites made of paramagnetic nanoparticles. The method comprises at least the following steps producing functional nanocomposites by the modified polyol method; mechanically blending the functional nanocomposites with natural rubber and adding vulcanising agents; and thermoforming the functional nanocomposite (see abstract).
Carlsson
Regarding instant claim 1, Carlsson et al. teach a pharmaceutical or veterinary formulation. The necessary citations within Carlsson et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Carlsson et al. Citations
A pharmaceutical or veterinary formulation, in the form of a sterile injectable dosage form, comprising:
Carlsson et al. disclose that the pharmaceutical compositions of the invention may be in the form of a sterile injectable or in fusible preparation, for example, as a sterile aqueous or oleaginous suspension of the inventive nanoparticles (see page 23, lines 11-14 within Carlsson et al.). Additionally, Carlsson et al. disclose that in general the therapeutically effective amount will vary depending on the active ingredient included in the nanoparticles, the disease state being treated, the severity of the disease treated, the age and relative health of the subject, the route and form of administration, the judgment of the attending medical or veterinary practitioner, etc. (see page 21, lines 5-9 within Carlsson et al.). Moreover, parenteral administration disclosed by Carlsson et al. encompasses administration by injection (see page 20, line 35 within Carlsson et al.).
a plurality of particles having a weight-, number-, or volume-based mean diameter that is between amount 1 mm and about 50 mm, which particles comprise solid cores comprising a biologically-active agent and a zinc oxide coating formed by atomic layer deposition; and
Carlsson et al. disclose coated nanoparticles comprising a core and an inorganic coating. The coating can be zinc oxide and the core contains a biologically active substance (see claims 1, 12, 14, and 15 within Carlsson et al.). In addition, Carlsson et al. disclose that the nanoparticle, comprising the core, the inorganic coating and optionally any
intermediate layers in between, has a size, expressed as the diameter of the nanoparticle from about 100 nm to about 50 μm, e. g. about 1 μm to about 50 μm, or about 10 μm to about 50 μm, such as about 20 μm to 50 μm (see page 8, lines 31-33 within Carlsson et al.). Furthermore, Carlsson et al. disclose the step of applying inorganic material to a plurality of the solid cores, comprises (a) introducing a first precursor, which is in a gaseous s t ate, into a reactor prefilled with the solid nanoparticles (the solid cores) to be coated; (b) purging and/or evacuating the reactor to remove the non-reacted or nonadsorbed precursor and the gaseous reaction by-products; (c) exposing the nanoparticles to a second precursor to activate the surface again for the reaction of the first precursor; (d) purging and/ or evacuating of the reactor and optionally repeating the steps (a) to (d) in order to achieve the desired coating thickness. This is a general Atomic Layer Deposition (ALD) process, well-known to the person of ordinary skill in the art. The steps a-d represent a reaction cycle or just cycle (see page 6, lines 11-23 within Carlsson et al.).
an oleaginous carrier system comprising a pharmaceutically-acceptable or veterinarily-acceptable oil and in which said particles are suspended.
Furthermore, Carlsson et al. disclose that the nanoparticles can be administered in form of different pharmaceutical formulations such as parenterally. A parenteral injection can contain olive oil as carrier (see page 23, lines 11-27 within Carlsson et al.). Also, Carlsson et al. disclose the broad use of a pharmaceutically acceptable carriers (see page 21, lines 4-5 and claims 22-23; all within Carlsson et al.). Additionally, Carlsson et al. disclose the composition may be formulated with a suitable ointment containing the inventive nanoparticles suspended in a carrier (see page 24, lines 18-19 within Carlsson et al.).
[Carlsson et al. disclose all the elements of instant claim 1 within the remaining instant claims of this 35 U.S.C. 103 section.]
Regarding instant claims 2 and 3, Carlsson et al. teach wherein the zinc oxide-coating comprises: one or more discrete zinc oxide layers surrounding said cores, said one or more discrete zinc oxide layers each comprising at least one separate zinc oxide coating. Carlsson et al. disclose a method of preparing a plurality of coated nanoparticles, said coated nanoparticles having a solid core comprising a biologically active substance, said solid core being enclosed by an inorganic coating; the method comprising applying one or more layers of inorganic material to a plurality of said solid cores by an application method wherein the inorganic material and/or precursors for forming the inorganic material is/are present in gas phase, and submitting said solid cores to agitation during and/or in between application of the layer(s) of inorganic material (see claim 1 within Carlsson et al.). In addition, Carlsson et al. disclose wherein the inorganic material comprises…zinc oxide (ZnO)… (see claim 12 within Carlsson et al.).
Regarding instant claim 4, Carlsson et al. teach a variety of biologically-active agents. Carlsson et al. disclose a biologically active substance according to the invention can be selected e.g. from analgesics, anesthetics, anti-inflammatory agents, anthelmintics, anti-arrhythmic agents, antiasthma agents, antibiotics, anticancer agents, anticoagulants, antidepressants, antidiabetic agents, antiepileptics, antihistamines, antitussives, antihypertensive agents, antimuscarinic agents, antimycobacterial agents,
antineoplastic agents, antioxidant agents, antipyretics, immunosuppressants,
immunostimulants, antithyroid agents, antiviral agents, anxiolytic sedatives
(hypnotics and neuroleptics), astringents, bacteriostatic agents, beta-adrenoceptor
blocking agents, blood products, blood substitutes, bronchodilators, buffering
agents, cardiac inotropic agents, chemotherapeutics, contrast media,
corticosteroids, cough suppressants (expectorants and mucolytics), diagnostic
agents, diagnostic imaging agents, diuretics, dopaminergics (antiparkinsonian
agents), free radical scavenging agents, growth factors, haemostatics,
immunological agents, lipid regulating agents, muscle relaxants, proteins, peptides
and polypeptides, parasympathomimetics, parathyroid calcitonin and
biphosphonates, prostaglandins, radio-pharmaceuticals, hormones, sex hormones,
anti-allergic agents, appetite stimulants, anoretics, steroids, sympathomimetics,
thyroid agents, vaccines, vasodilators, and xanthines (see page 10, lines 6-23 within Carlsson et al.). Furthermore, Carlsson et al. goes on to describe specific poorly water-soluble drugs that can be used within the nanoparticle (see page 10, lines 25-36 and page 11, lines 1-5 within Carlsson et al.). A skilled artisan (POSITA; person of ordinary skill in the art) could easily combine any of the two ingredients for the core as needed by a subject.
Regarding instant claim 7, Carlsson et al. teach wherein more than one discrete layer of zinc oxide is applied to the core sequentially. Carlsson et al. disclose …the method comprising applying one or more layers of inorganic material to a plurality of said solid cores by an application method… (see claim 1 within Carlsson et al.). Moreover, Carlsson et al. disclose that basically, the contact holes may be avoided by keeping the particles in motion during at least part of the coating process, e. g. by use of a fluidized bed, or by submitting the particles to an agitation treatment between sequential applications of inorganic material to the particles, so as to obtain a disaggregation of any particle aggregates formed during application of coating, and/ or so as to obtain a rearrangement of particles (see page 17, lines 9-14 within Carlsson et al.).
Regarding instant claim 8, Carlsson et al. teach wherein between 3 and 10 discrete layers of zinc oxide are applied. Carlsson et al. disclose that the nanoparticle may comprise one or several layers of one or more metal oxides (including zinc oxide) (see page 12, lines 5-6 within Carlsson et al.). For example, Carlsson et al. disclose three layers of inorganic coating (see Example 5 within Carlsson et al.).
Regarding instant claim 9, Carlsson et al. teach wherein the total thickness of the zinc oxide coating is between about 0.5 nm and about 2 mm. Carlsson et al. disclose a coating of about 10-20 nm thick (see Example 5 within Carlsson et al.). Although this example uses aluminum oxide, the inorganic material for the coating may be zinc oxide (see claim 12 within Carlsson et al.).
Regarding instant claim 10, Carlsson et al. teach wherein the maximum thickness of an individual discrete layer of zinc oxide coating is about 1 hundredth of the weight-, number-, or volume-based mean diameter of the core, including any other discrete layers that have previously been applied to the core. Based on the instant claim 9 discussion and a 10-20 nm thick coating, Carlsson et al. allows for an approximately 0.5 mm to 3 mm core size (see Example 5 within Carlsson et al.; core and coating size: 100 x 10 nm = 1000 nm = 1 mm and 100 x 20 nm = 2000 nm = 2 mm ). This would produce a nanoparticle within the cited diameter range (see the discussion and citations within instant claim 1).
Regarding instant claim 15, Carlsson et al. teach a process for the preparation of a formulation as defined in instant claim 1, wherein the coated particles are made by applying the layer(s) of zinc oxide coating material to the cores, and/or previously-coated cores, by atomic layer deposition. Carlsson et al. disclose wherein said inorganic material is applied by atomic layer deposition, chemical vapour deposition or physical vapour deposition (see claim 8 within Carlsson et al.) (also see PTO-892 NPL V).
Regarding instant claim 16, Carlsson et al. teach the process as claimed in instant claim 15, wherein: (i) solid cores are coated with a first discrete layer of zinc oxide; (ii) the coated cores from step (i) are then subjected to a deagglomeration process step; (iii) the deagglomerated coated cores from step (ii) are then coated with a second discrete layer of zinc oxide; (iv) repeating steps (ii) and (iii) to obtain the required number of discrete layers of zinc oxide. Carlsson et al. disclose a method of preparing the coated nanoparticles (see claim 1 within Carlsson et al.). Additionally, Carlsson et al. disclose the deagglomeration step between subsequent coatings (see Examples 5-9 within Carlsson et al.). Furthermore, Carlsson et al. disclose wherein the inorganic material comprises…zinc oxide (ZnO)… (see claim 12 within Carlsson et al.).
Regarding instant claim 23, Carlsson et al. teach wherein the biologically active agent in the solid core is one that dissolves when exposed to an aqueous solvent. A skilled artisan (POSITA) would under routine experimental conditions select an aqueous soluble biologically active agent.
Regarding instant claim 24, Carlsson et al. teach wherein the biologically active agent is a peptide. Carlsson et al. disclose where the biologically active agent is a peptide (see page 10, lines 19-20 within Carlsson et al.).
Combination of Carlsson et al. and Edelson et al.
Regarding instant claims 11-12, Carlsson et al. and Edelson et al. teach wherein the carrier system comprises one or more medium chain triglycerides. Carlsson et al. has established the use of a pharmaceutically acceptable carrier (see the discussion and citations within instant claim 1). Edelson disclose that the fatty acid group (oily media, carrier) may be a medium chain triglyceride (MCT) (see paragraphs [0112] and [0114] both within Edelson et al.). Additionally, Edelson et al. disclose the use of more than one MCT oil (see paragraph [0115] within Edelson et al.).
Regarding instant claims 14 and 21, Carlsson et al. and Edelson et al. teach wherein the sterile injectable dosage form, following injection forms a depot formulation. Carlsson et al. disclose both an immediate or quick and a prolonged release having particles of varying thickness (see page 24, lines 4-12 within Carlsson et al.). Similarly, Edelson et al. disclose the use of a depot (for prolonged release) of the pharmaceutical agent (see paragraphs [0291] and [0293] within Edelson et al.). Edelson et al. additionally, disclose transdermal patches which may further comprise a plurality of needles extending from the one side of the patch that is applied to the skin, wherein needles extend from the patch to project through the stratum corneum of the skin (see paragraph [0290] within Edelson et al.). Thus, these needles inject the biologically-active agent to form a depot. Also, Carlsson et al. disclose the parenteral injection of the nanoparticles (see page 23, lines 11-14 within Carlsson et al.). Therefore, the above teachings support the surgical administration apparatus (needle) to inject a prolonged release (depot formulation) into a subject.
Regarding instant claim 19, Carlsson et al. and Edelson et al. teach the wherein the coated particles are mixed with the carrier system after coating. Although this text is not cited within Carlsson et al., it would be obvious based on the teachings of Edelson et al. and Carlsson et al. to synthesize the coated nanoparticles, and then added the pharmaceutical carrier of choice prior to administration.
Regarding instant claim 20, Carlsson et al. and Edelson et al. teach an injectable and/or infusible dosage form comprising a formulation as defined in instant claim 1 contained within a reservoir and an injection or infusion means. Please see the discussion and citations within instant claim 1. The combination of both Carlsson et al. and Edelson et al. disclose pharmaceutically acceptable carriers (see the discussion and citations within instant claim 1 and 11). Furthermore, Carlsson et al. disclose that the nanoparticles can be administered in form of different pharmaceutical formulations such as parenterally (sterile injectable or infusible preparation) (see page 23, lines 11-27 within Carlsson et al.).
Regarding instant claim 22, Carlsson et al. and Edelson et al. teach the dosage form as claimed in instant claim 21, wherein the coated particles and the carrier system are housed separately, and admixing of the coated particles and carrier system to form the formulation occurs in the reservoir prior to and/or during injection or infusion. Although this text is not cited within Carlsson et al., it would be obvious based on the teachings of Edelson et al. and Carlsson et al. to synthesize the coated nanoparticles, and then add the carrier system to form the formulation prior to and/or during injection or infusion depending upon the need of the patient.
Combination of Carlsson et al. and Job et al.
Regarding instant claim 17, Carlsson et al. and Job et al. teach process as claimed in instant claim 16, wherein the deagglomeration step that takes place between applications of coatings comprises sieving. Carlsson et al. disclose the process steps discussed within instant claim 16. However, Carlsson et al. disclose the use of sonication during the deagglomeration steps (see Examples 5-9, within Carlsson et al.). Job et al. disclose the use of sieving during the deagglomeration process (see page 14, lines 12-16 within Job et al. and English translation PTO-892 NPL X). Thus, a skilled artisan (POSITA) would be able to integrate the sieving step into the process outlined by Carlsson et al. under routine experimental conditions.
In the context of instant process claims 15-19, the desired purpose defines an effect that arises from, and is implicit in the process step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed process step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present process claims, defining the application/use of the composition according to the previous instant claims and defining its purpose as "preparation", is anticipated by any document of the state of the art describing a process/method of preparing the composition.
Analogous Art
The Carlsson et al., Edelson et al., and Job et al. references are directly relevant to the endeavor of the instant application. The Examiner concedes that the Edelson et al. and Job et al. references do not teach all the elements of instant claim 1. However, Edelson et al. and Job et al. do teach numerous claim limitations within the instant application. Therefore, these teachings make the references relevant to instant claims 1-4, 7-12, and 14-24.
Obviousness
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 solid nanoparticle with inorganic coating disclosed by Carlsson et al., using the teachings of Edelson et al. and Job et al. to incorporate the necessary claim limitations. Starting with Carlsson et al., the skilled person only had to try the addition of the necessary claim limitations disclosed by Edelson et al. and Job et al. The combination of Carlsson et al., Edelson et al. and Job et al. would allow one to arrive at the present application without employing inventive skill. This combination of the solid nanoparticle with inorganic coating taught by Carlsson et al. along with the use of the necessary claim limitations taught by Edelson et al. and Job et al., would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the solid nanoparticle with inorganic coating disclosed by Carlsson et al. with the use of the necessary claim limitations taught by Edelson et al. and Job et al. This combined modification would have led to an enhanced the solid nanoparticle with inorganic coating formulation that would be beneficial for consumers and patients.
Allowable Subject Matter
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The subject matter wherein the sieving comprises sonic shifting is not within the prior art of record. Motivation is lacking to add this instant claim limitation.
Response to Arguments
Applicant's arguments filed October 23, 2025 have been fully considered but they are not persuasive.
The Applicant’s claim amendments were sufficient to address the claim objections. Furthermore, Applicant’s arguments and claim amendments were persuasive in addressing the 35 U.S.C. §102 rejection. Therefore, the claim objections and 35 U.S.C. §102 rejection from the Non-Final office action dated April 16, 2025 are withdrawn.
The Applicant’s claim amendments did not necessitate a new ground of rejection.
The Kaminaikas et al. reference was withdrawn from the record due the cancellation of instant claim 5.
Applicant Argument: The Applicant argues that the Examiner is picking and choosing among the various embodiments of Carlsson et al. and that the preferred formulation composition is not stated within the disclosure to align with the instant application.
Examiner’s Rebuttal: As stated above, the Examiner was persuaded by the claim amendments and arguments submitted on October 23, 2025 to withdraw the 35 U.S.C. §102 rejection. The motivation to use a preferred formulation parallel to the present application is not disclosed by Carlsson et al. However, the 35 U.S.C. §103 rejection is maintained due to the disclosure within Carlsson et al. which does teach the necessary claim limitations, despite its lack of motivation to select the desired composition. For example, claim 12 within Carlsson et al. lists the inorganic material to include zinc oxide (ZnO) among eleven other components. The specification does not afford the motivation to select this inorganic coating, yet it is disclosed, thus supporting a 35 U.S.C. §103 rejection.
Applicant Argument: The Applicant argues that the Edelson et al. reference does not specifically teach the injection and discloses a transdermal patch depot formulation.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Carlsson et al. disclose both an immediate or quick and a prolonged release having particles of varying thickness (see page 24, lines 4-12 within Carlsson et al.). Similarly, Edelson et al. disclose the use of a depot (for prolonged release) of the pharmaceutical agent (see paragraphs [0291] and [0293] within Edelson et al.). Edelson et al. disclose transdermal patches which may further comprise a plurality of needles extending from the one side of the patch that is applied to the skin, wherein needles extend from the patch to project through the stratum corneum of the skin (see paragraph [0290] within Edelson et al.). Thus, these needles inject the biologically-active agent and produce a formulation depot. Also, Carlsson et al. disclose the parenteral injection of the nanoparticles (see page 23, lines 11-14 within Carlsson et al.). Therefore, the above teachings support the surgical administration apparatus (needle) to inject a prolonged release (depot formulation) into a subject.
Applicant Argument: The Applicant argues Job et al. does not disclose the deagglomeration subsequent to blending the functional nanocomposites with natural rubber and adding vulcanizing agents.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The citation from Job et al. does support the deagglomeration, “The precursor powder was then de-agglomerated in an agate mortar and passed through a 325 mesh sieve, opening at 45 pm. After the deagglomeration and sieving steps, the precursor powder started to have a dark gray color, showing a fine and homogeneous aspect.” (see page 10, paragraph 4 within Job et al. BR102012005278A2 or see page 14, lines 12-16 within Job et al. WO2013131159A1 English translation).
Applicant Argument: The Applicant argues that the 35 U.S.C. §103 rejection is not proper using Carlsson et al.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The Carlsson et al. reference as discussed above does not express the proper motivation to select the claimed invention. This is sufficient to withdraw the 35 U.S.C. §102 rejection. However, the full disclosure within Carlsson et al. makes the cited claim limitations obvious to a skilled artisan (POSITA). Since, one reference is questioned here, the numerous combinations from a broad specification were enough to withdraw the anticipation rejection but not the obviousness rejection. If the hypothetical situation occurred where multiple references taught the claimed limitations requiring undue experimentation, then the argument would be more persuasive.
Applicant Argument: The Applicant argues that the unexpected results by the inventors support patentability of the instant application.
Examiner’s Rebuttal: The Examiner respectfully disagrees. The unexpected results are interesting however, they are not strong enough to withdraw the prior art of record [MPEP §716.02(d) cites: Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of non-obviousness 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) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100°C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110°C and 130°C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60°C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100°C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).].
For example, over the complete particle size range of 1 mm to 50 mm comprising a biologically-active agent, a zinc oxide coating formed by atomic layer deposition, and a oleaginous carrier system, are these unexpected results observed?
Furthermore, Applicant fails to show comparison data with the closest prior art to support these unexpected results. [The Examiner searched throughout and was unable to locate any comparison data.].
Therefore, the 35 U.S.C. §103 rejection is maintained for instant claims 1-4, 7-12, and 14-24.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615