DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/20/2025 has been entered.
Response to Amendment
The amendment of claims 1, 28 are supported by the specification.
Any rejections and/or objections made in the previous Office action and not repeated below are hereby withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 28 are rejected under 35 U.S.C. 101 because the claims are directed to neither a “composition” nor an “article of manufacture,” but rather embraces or overlaps two different statutory classes of invention set forth in 35 U.S.C. §101, which is drafted so as to set forth the statutory classes of invention in the alternative only.
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.
Claims 1, 3-9, 11, 15-17, 19, 24-26, 28-29 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 pre-AIA the applicant regards as the invention.
Claims 1, 28 contain limitations that are drawn to both a composition and an article of manufacture. Case law holds that a single claim that claims both a composition and the method steps of using it is indefinite under 35 U.S.C. 112(b). See Ex Parte Lyell, 17 USPQ 2d 1548 (Bd. Pat. App. 7 Inter.1990). If applicant intends to define the physical form of the claimed composition, the claim should be amended to “A pellet comprising” or “A pellet made from a composition comprising”.
Claim Rejections - 35 USC § 103
Claims 1, 3-9, 11, 15-17, 19, 24-25, 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zia et al (US 2015/0111796) in view of Duijnhoven Van et al (US 2011/0034609).
Claims 1, 3-5, 11, 30: Zia discloses a composition for medical inhalers comprising at least 90 wt% of polyoxymethylene, 0.1-5 wt% of a colorant, a formaldehyde scavenger [0083, 0049, 0045, 0075-0079, 0089], the POM has a melt flow index of less than 25g/10min when measured at 190°C and 2.16Kg, POM has a density of 1.41g/cm3, so the corresponding melt volume flow rate is 17.7cm3/10 min. The composition is latex free and contains nothing related to animal. The composition further comprises an acid scavengers, antioxidants, nucleants [0073]. The colorant would color the composition throughout. The colorant can be titanium dioxide [0083], which reads on a rutile pigment. The composition may be formed into pellets [0088].
Because Zia teaches the composition is for medical inhalers and injectors , it is therefore inherent that the composition has low extractives, metal and metalloids, and passes the claimed testing so that the composition can be used for preparing medical inhalers and injectors.
Zia does not teach a laser marking additive as claimed.
However, a composition comprising a laser marking additive will form a mark (e.g. dose indicator, serial number etc.) by color changing when exposed to a laser without introducing ink or adhesive on the surface of articles. Duijnhoven Van discloses encapsulated antimony oxide can be used as laser marking additive for medical device [example, 0035]. In the encapsulated particles, the laser marking additive is carried within a polymer matrix including a compatibilizer and a carrier polymer such as polyethylene. The weight ratio of the laser marking additive to the polymer matrix is 56:30, i.e. 65:35 (table 1, example MB06). An exemplary amount of the laser marking additive is 3 wt% in the polymer composition (table 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include a laser marking additive to form a mark on medical devices without using ink or adhesive which may falling off from the article surface.
Claims 6-9, 17, 19: Zia discloses the composition further comprises 0.0075-0.5 wt% of an acid scavenger such as tricalcium citrate, an antioxidant such as triethylene glycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionate] (i.e. Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]), a terpolymers nucleant, a lubricant such as ethylene bis(stearamide), 5-45 wt% of a reinforcing fiber such as glass fiber [0083, 0049, 0045, 0075-0079, 0088, 0081, 0085].
Zia et al. does not expressly name a single embodiment having the claimed composition. However, each of the components of the composition is described in the reference. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the present invention to have made any of the compositions suggested by the reference, including the claimed composition, thereby arriving at the presently claimed invention.
Claims 15-16, 24: Zia does not explicitly teach the composition contains more than 2 coloring agents.
However, it is a well-known practice to mix various coloring agents to produce a color which cannot be presented by a single colorant. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize more than two colorants to provide the article with desired color.
Claim 25: Zia teaches the composition further comprises antioxidants etc. [0073].
Claim 28-29: the claim limitations has been addressed in claim 1 and claim 11.
Claims 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zia et al (US 2015/0111796) in view of Duijnhoven Van et al (US 2011/0034609) and further in view of Disch et al (US 8,053,499).
Zia and Duijnhoven Van discloses the limitation of claim 25, as discussed above. Zia further teaches the composition comprising formaldehyde scavenger such as pyridine, melamine etc [0075-0076].
Zia and Duijnhoven Van do not teach dicyandiamide as claimed.
However, Disch discloses a polyoxymethylene composition and teaches pyridine, melamine, dicyandiamide etc are an effective formaldehyde scavenger (claim 6, 5:56-62). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use dicyandiamide because it is recognized in the art it is a suitable formaldehyde scavenger for polyoxymethylene composition.
Response to Arguments
Applicant's arguments filed 8/20/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that USP Class VI is different from the standards used for injectors and inhalers, the argument is insufficient because 1) it is unclear if ISO 18562 is the only standard utilized for medical inhalers, if ISO 7886 and ISO 11608 are the only standards utilized for medical injectors. It is unclear if inhaler and injector should pass USP Class VI and ISO 10993 testing or not. It will be more persuasive if evidence is provided to show inhaler and injector do not need to pass USP Class VI and ISO 10993 testing. 2) ISO 7886 section 6.3 lists limits for extractable metals should be no more than a combined total of 5mg/Kg. 3) A declaration with a statement like “medical inhalers and injectors do not need to pass USP Class VI and ISO 10993 testing” would be sufficient.
In response to applicant's argument that there is no motivation for a person skilled in the art to analyze the inhaler and injector of Zia and independently derive the claimed feature, it is noted that the fact that the inventor has recognized another advantage or feature which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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/WENWEN CAI/
Primary Examiner, Art Unit 1763