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 .
Response to Amendment
The amendment of claims 1, 28 are supported by the specification. The new claim 32 is 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Any rejections and/or objections made in the previous Office action and not repeated below are hereby withdrawn.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.
The new grounds of rejection set forth below are necessitated by applicant's amendment filed on 4/27/2026. Thus, the following action is properly made final.
Claim Objections
Claims 3-9, 11, 15-17, 19, 24-26, 29, 31-32 objected to because of the following informalities: the preamble should be consist with the independent claim and should be started with the term “the”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 31 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
For claim 31, the specification does not support “less than about 0.5% by weight” nor “vegetable based”.
Claim Rejections - 35 USC § 103
Claims 1, 3-9, 11, 15-17, 19, 24-25, 28-29, 32 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: 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.
Claim 32: primary aromatic amine presents well known safety risks when delivered directly to the lungs, such as toxic and potentially carcinogenic effects including bladder cancer and forming reactive metabolites that damage biological tissues. Inhalation bypasses many of the body’s normal detoxification pathways, increasing systemic exposure and risk even at low levels. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to control primary aromatic amines at a tightly controlled trace level.
Claims 26, 31 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).
Claim 26: 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.
Claim 31: Zia discloses the composition comprises a lubricant such as ethylene bis(stearamide) in an amount of 0.01-0.5wt% [0081], a polyoxymethylene terpolymer nucleant in an amount of 0.1-1 wt% [0078], 0.0075-0.5 wt% of an acid scavenger such as tricalcium citrate [0077]. It is noted that “vegetable based” is a product-by-process limitation and has no patentable weight.
the amount of dicyandiamide is not explicitly disclosed.
However, the amount is a result effective variable where insufficient amount may result in suboptimal performance, whereas excessive amounts lead to unnecessary cost. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to adjust the content through routine experimentation. Case law holds that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive.
In response to applicant's argument regarding “Use of international standard ISO 10993-1”, it is noted that 1) page 7 does not have the cited sentence “when assessing new devices, the sponsor should specifically state if the device does not have any direct or indirect tissue contact, and no further biocompatibility information would be needed”; 2) it is unclear how that sentence can draw the conclusion that inhaler does not need to pass ISO 10993 testing; 3) applicant is requested to provide more explanations that if an inhaler does or does not have a direct or indirect tissue contact and how to relate that sentence to the point of contention; 4) Zia discloses the composition is used for making inhaler, it is obvious to one skilled in the art that the composition can be used to make all components of an inhaler; 5) is the biocompatibility the only test that an inhaler needs to pass, or is the biocompatibility a test that an inhaler needs to pass?
In response to applicant's argument regarding USP Class VI, it is noted that an inhaler is a device not just contacting skin, when something is inhaled, it bypasses a lot of the body’s natural detox barriers, so even small amounts can be more concerning than oral exposure.
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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/WENWEN CAI/
Primary Examiner, Art Unit 1763
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