DETAILED ACTION
The Office acknowledges receipt of the Applicant’s response filed 15 December 2025.
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 .
Claim Interpretation
Claim 30 is deemed to be improperly labeled because it is noted (via underline) as adding the language, “wherein the surface roughness of the sealing surface is predetermined based on an estimated shrinkage of the sealing assembly associated with the glass container when the sealing assembly is cooled to temperatures less than or equal to -80°C”. This language was previously presented in the claims of 11 August 2025. This appears to be to address a claim objection from the previous Office Action of 1 October 2025 where the cited language was added without underlining and is interpreted as such for the purposes of examination.
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 30-36 and 40-42 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.
Regarding claim 30, the claim recites, “wherein the surface roughness of the sealing surface is predetermined based on an estimated shrinkage of the sealing assembly associated with the glass container when the sealing assembly is cooled to temperatures less than or equal to -80°C”. This is deemed to be indefinite, because the claim can be read such that it appears to be claiming a mental process (i.e. an abstract idea which is a judicial exception to eligible subject matter for a patent) in that it is claiming a mental process step for someone performing the method. The claim does not set forth any means or mechanism by which such a determination of the surface roughness is made, nor does the specification. The claim is essentially reciting a motivation for why a particular value of the surface roughness was chosen, and not a step of a device or mechanism that makes such a determination.
As such, this language is being treated an internal mental process of the performer of the method and is simply a motivation for why a value was chosen. Any prior art, or combination thereof, which discloses or teaches the physically performed steps and structures those steps are transforming will be deemed to read on the claim as written irrespective of the motivations behind those steps and transformations.
Claims 31-36 and 40-42 are rejected to for being dependent on claim 30.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 30, 35-36 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckhoff et al. (US 2015/0211950 A1) hereinafter referred to as Eckhoff in view of Matweb (Aluminum, Al; https://www.matweb.com/search/DataSheet.aspx?MatGUID=0cd1edf33ac145ee93a0aa6fc666c0e0; Retrieved 16 March 2017) hereinafter referred to as Matweb-Aluminum in view of Takahashi (US 2018/0044056 A1).
Regarding claim 30, Eckhoff discloses a method of sealing a sealed pharmaceutical container (200; 1100; 1300), the method comprising the steps of:
providing a sealed pharmaceutical container (200, paragraph 0039; 1100; 1300) comprising a shoulder, a neck extending from the shoulder and a flange extending from the neck (see annotated fig. 2 below; comparable sections also seen in figs. 11A and 13A), the flange comprising:
an underside surface extending from the neck (see annotated fig. 2 below);
an outer surface extending from the underside surface, the outer surface defining an outer diameter of the flange (see annotated fig. 2 below); and
a sealing surface extending between the outer surface to an inner surface of the sealed pharmaceutical container that defines an opening (see annotated fig. 2 below), wherein the sealing surface is flat (see figs. 2, 11a and 13a; sealing surfaces are flat; paragraph 0050 – “headspace 240 is defined as a volume of sealed space”, paragraph 0058 – “a septa and aluminum seal that can withstand positive pressures”; The sealing surface of Eckhoff is a flat surface that is sufficient to create a seal);
inserting a pharmaceutical composition (210, 1120, 1320) into the sealed pharmaceutical container (paragraph 0038 – “FIG. 2 is a schematic of a pharmaceutical vial filled for use with a syringe”; fig. 10 - #1010; figs. 11A-D, paragraph 0091; figs. 13A-13D, paragraph 0101);
providing a sealing assembly (250, 270; 1170, 1180; 1340, 1350) comprising a stopper (250; 1170; 1340) extending over the sealing surface of the flange and covering the opening (fig. 2; figs. 11A-D; figs. 13A-D);
crimping a metal-containing cap (#270, paragraph 0057; #1180, paragraph 0091; #1350, paragraph 0104, 0171) over the stopper and against flange to thereby compress the stopper against the sealing surface, wherein the metal-containing cap comprises a solid metal (paragraph 0057 – “the seal is constructed of aluminum”), a metallic alloy, or a polymer metal composite and has a CTE of greater than or equal to 260×10−7/K (paragraphs 0057, 0059 – “aluminum crimping seal”; paragraph 0091 – “seal 1180, e.g., an aluminum crimp seal”; paragraph 0101; Aluminum is known to have this property); and
cooling the sealed pharmaceutical container to a temperature of less than or equal to −45° C, (paragraph 0098 – Low-temperature storage of -80° C is contemplated by the prior art), wherein, after the cooling of the sealed pharmaceutical container, the compression is maintained on the sealing surface such that a helium (paragraph 0088 – “calculating… a molar amount of the inert gas for filling the volume of headspace sufficient to generate the push pressure; … the inert gas includes at least one of argon, helium, or nitrogen”; Paragraphs 0096, 0168; Helium is selected as a gas used to create a positive push pressure in the container for the shelf life of the container) leakage rate of the sealed pharmaceutical container is less than or equal to 1.4×10−6 cm3/s at the temperature (paragraph 0060 – “vial cap 250 and seal 270 are configured to maintain a push pressure within the pharmaceutical vial”; paragraph 0090 – “sealing the filled recommended pharmaceutical vial with the recommended vial cap with seal to maintain the predetermined push pressure within the filled recommended pharmaceutical vial”; paragraph 0091 – “an aluminum crimp seal, to maintain the push pressure within sealed pharmaceutical vial 1100”; paragraph 0098 – “sealing the recommended pharmaceutical vial with the vial cap with seal, and resealing the vial cap with seal with an energy source to maintain the push pressure in the recommended pharmaceutical vial”; paragraph 0101 – “Sealing the puncture maintains the push pressure in pharmaceutical vial 1300 created by inert gas 1380”).
Wherein the Applicant may argue that Eckhoff does not explicitly disclose the step of cooling, the Office previously took official notice in the Office Action of 11 March 2025 that it would have been obvious to one of ordinary skill in the art before effective filing to cool the sealed pharmaceutical container to a temperature of less than or equal to −45° C. Eckhoff discloses how low temperature storage of such containers was contemplated at -80° C. To accomplish this it would require having the containers be cooled to that temperature which is less than the −45° C required by the claim limitations. Having the cooling step would be advantageous because it is often the case that pharmaceutical products need to be stored at low or specific ranges to maintain their effectiveness or reduce the chance of spoilage. The common knowledge or well-known in the art statement is taken to be admitted prior art because applicant failed to traverse the examiner’s assertion of official notice (MPEP 2144.03 C).
Furthermore, given that the purpose of the invention of Eckhoff is to maintain the positive push pressure within the container during the storage life of the product, it would have been obvious to have the helium leakage rate of the sealed pharmaceutical container is less than or equal to 1.4×10−6 cm3/s at the temperature. Eckhoff already discloses that helium is the gas being kept at positive pressure over an extended period of time (i.e. the shelf life of the product). It has been held that where the generally conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art (MPEP 2144 II). It would have been obvious to one having ordinary skill in the art before the time of effective filing to have the helium leakage rate less than or equal to 1.4×10−6 cm3/s at the temperature range. Any amount of leakage would not allow for Eckhoff to perform its primary function of maintaining a positive pressure over the shelf life of the product so having it less than the claimed amount would have been preferred.
Wherein the Applicant may argue that a CTE of greater than or equal to 260×10−7/K is not explicitly disclosed, the Office further points to Matweb-Aluminum which teaches that aluminum was known to have a CTE of greater than or equal to 260×10−7/K (p. 2 – “CTE, linear… 24.0μm/m-°C… 25.5μm/m-°C… 27.4μm/m-°C”; At least the value of 27.4μm/m-°C is in the claimed range).
Given the teachings of Matweb-Aluminum, it would have been obvious to one of ordinary skill in the art before the time of effective filing to have the metal-containing aluminum cap of Eckhoff have a CTE of greater than or equal to 260×10−7/K. Such a CTE was a known property of aluminum. Having aluminum conform to its known properties is obvious to anyone who would want to manufacture it within desired tolerances and specifications so that it was predictable to function as intended. Furthermore, where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art (MPEP 2144 II).
Eckhoff discloses wherein the sealing surface is flat and is cooled to temperatures less than or equal to -80°C (paragraph 0098), but does not disclose wherein the sealing surface has a surface roughness of less than or equal to 0.1 μm.
However, Takahashi teaches a sealed container (figs. 1A-C) a sealing surface (12) has a surface roughness of less than or equal to 0.1 μm (paragraph 0074 – “The ground joint surfaces were polished until the surface roughness became 0.5 μm or less”; paragraph 0075 – “the surface roughness Ra of the ground joint surfaces was 0.157 μm… verticality was 0.1 to 1.5 μm”; paragraph 0087; claim 4).
Given the teachings of Takahashi, it would have been obvious to one of ordinary skill in the art before the time of effective filing to have the glass container sealing surface of Eckhoff have a surface roughness of less than or equal to 0.1 μm as taught by the glass container sealing surface of Takahashi. Doing so would result in having fewer defects in the sealing portions of the glass and allow for better contact with sealing elements to create a better seal.
The Office notes that Takahashi denotes that the surface roughness of the sealing surface can be “0.5 μm or less”. This includes values of less than or equal to 0.1 μm (see MPEP 2144.05 I). Takahashi also denotes a “verticality of 0.1 to 1.5 μm” which would include a surface roughness of less than or equal to 0.1 μm. Wherein the Applicant may argue that a surface roughness of less than or equal to 0.1 μm is not expressly taught by Takahashi, the Office alternatively further notes that it would have been obvious to one of ordinary skill in the art at the time of effective filing to have the surface roughness of Eckhoff as modified by Takahashi be less than or equal to 0.1 μm. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. (In re Aller, 105 USPQ 233; MPEP 2144.05 I and II). Having a smoother surface would lead to a tighter seal which is an outcome desired by both Eckhoff and Takahashi.
The combination of Eckhoff and Takahashi is therefore deemed to disclose a sealing surface has a surface roughness of less than or equal to 0.1 μm and wherein the surface roughness of the sealing surface is predetermined based on an estimated shrinkage of the sealing assembly associated with the glass container when the sealing assembly is cooled to temperatures less than or equal to -80°C (Eckhoff – paragraph 0098; Takashi – paragraphs 0074-0075; see 35 USC 112b above).
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Regarding claim 35, Eckhoff as modified above discloses wherein the sealing assembly (250, 270; 1170, 1180; 1340, 1350) maintains the helium (paragraph 0088 – “calculating… a molar amount of the inert gas for filling the volume of headspace sufficient to generate the push pressure; … the inert gas includes at least one of argon, helium, or nitrogen”; Paragraphs 0096, 0168; Helium is selected as a gas used to create a positive push pressure in the container for the shelf life of the container) leakage rate of the sealed pharmaceutical container of less than or equal to 1.4×10-6 cm3/s (paragraph 0060 – “vial cap 250 and seal 270 are configured to maintain a push pressure within the pharmaceutical vial”; paragraph 0090 – “sealing the filled recommended pharmaceutical vial with the recommended vial cap with seal to maintain the predetermined push pressure within the filled recommended pharmaceutical vial”; paragraph 0091 – “an aluminum crimp seal, to maintain the push pressure within sealed pharmaceutical vial 1100”; paragraph 0098 – “sealing the recommended pharmaceutical vial with the vial cap with seal, and resealing the vial cap with seal with an energy source to maintain the push pressure in the recommended pharmaceutical vial”; paragraph 0101 – “Sealing the puncture maintains the push pressure in pharmaceutical vial 1300 created by inert gas 1380”) as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −80° C (paragraph 0098 – Low-temperature storage of -80° C is contemplated by the prior art).
Given that the purpose of the invention of Eckhoff is to maintain the positive push pressure within the container during the storage life of the product, it would have been obvious to have the helium leakage rate of the sealed pharmaceutical container is less than or equal to 1.4×10−6 cm3/s at the temperature. Eckhoff already discloses that helium is the gas being kept at positive pressure over an extended period of time (i.e. the shelf life of the product). It has been held that where the generally conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art (MPEP 2144 II). It would have been obvious to one having ordinary skill in the art before the time of effective filing to have the helium leakage rate less than or equal to 1.4×10−6 cm3/s at the temperature −80° C. Any amount of leakage would not allow for Eckhoff to perform its primary function of maintaining a positive pressure over the shelf life of the product so having it less than the claimed amount would have been preferred.
Regarding claim 36, Eckhoff as modified above discloses wherein the sealing assembly (250, 270; 1170, 1180; 1340, 1350) maintains the helium (paragraph 0088 – “calculating… a molar amount of the inert gas for filling the volume of headspace sufficient to generate the push pressure; … the inert gas includes at least one of argon, helium, or nitrogen”; Paragraphs 0096, 0168; Helium is selected as a gas used to create a positive push pressure in the container for the shelf life of the container) leakage rate of the sealed pharmaceutical container of less than or equal to 1.4×10-6 cm3/s (paragraph 0060 – “vial cap 250 and seal 270 are configured to maintain a push pressure within the pharmaceutical vial”; paragraph 0090 – “sealing the filled recommended pharmaceutical vial with the recommended vial cap with seal to maintain the predetermined push pressure within the filled recommended pharmaceutical vial”; paragraph 0091 – “an aluminum crimp seal, to maintain the push pressure within sealed pharmaceutical vial 1100”; paragraph 0098 – “sealing the recommended pharmaceutical vial with the vial cap with seal, and resealing the vial cap with seal with an energy source to maintain the push pressure in the recommended pharmaceutical vial”; paragraph 0101 – “Sealing the puncture maintains the push pressure in pharmaceutical vial 1300 created by inert gas 1380”) as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −80° C (paragraph 0098 – Low-temperature storage of -80° C is contemplated by the prior art).
Eckhoff does not explicitly disclose having a temperature of equal to or less than −100° C. However, the Office notes that the stopper of Eckhoff can be comprised of materials that have a glass transition temperature (Tg) of −100° C or less (paragraphs 0054-0055; PTFE is known to have a Tg of approx. −110° C and silicone is known to have a Tg of approx. −115° C).
Given that the purpose of the invention of Eckhoff is to maintain the positive push pressure within the container during the storage life of the product, it would have been obvious to have the helium leakage rate of the sealed pharmaceutical container less than or equal to 1.4×10−6 cm3/s at the temperature of −100° C. Eckhoff already discloses that helium is the gas being kept at positive pressure over an extended period of time (i.e. the shelf life of the product). It has been held that where the generally conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art (MPEP 2144 II). It would have been obvious to one having ordinary skill in the art before the time of effective filing to have the helium leakage rate less than or equal to 1.4×10−6 cm3/s at the temperature −100° C. Any amount of leakage would not allow for Eckhoff to perform its primary function of maintaining a positive pressure over the shelf life of the product so having it less than the claimed amount would have been preferred. Eckhoff also discloses stopper materials capable of having their rubber characteristics at such low temperature and being able to provide such at a low temperature is valuable for pharmaceutical products which are required to be stored at such low temperatures.
Regarding claim 41, Eckhoff discloses wherein the stopper comprises a radially heterogeneous composition (figs. 2, 11 and 13; paragraph 0054 – “the vial cap may be a stopper made of a non-reactive elastomeric material. For example, the vial cap may be a stopper constructed of a type of butyl rubber... Non-limiting examples of non-reactive elastomeric materials for a stopper include rubber, butyl rubber, bromobutyl rubber, ethylene propylene diene monomer (EPDM) rubber, fluorocarbon elastomers, polytetrafluoroethylene (PTFE), chlorobutylisoprene, or combinations thereof… the rubber stopper may be at least partially coated with a fluorinated resin”).
Claim(s) 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckhoff (US 2015/0211950 A1) in view of Matweb-Aluminum (Aluminum, Al; https://www.matweb.com/search/DataSheet.aspx?MatGUID=0cd1edf33ac145ee93a0aa6fc666c0e0; Retrieved 16 March 2017) in view of Takahashi (US 2018/0044056 A1) in view of Thibault et al. (US Patent 6,090,093) hereinafter referred to as Thibault.
Regarding claim 31, Eckhoff fails to disclose wherein the sealing surface extends at an angle relative to a plane extending through an end of the opening such that a distance between the sealing surface and the plane increases with decreasing radial distance from the outer surface.
However, Thibault teaches wherein the sealing surface extends at an angle relative to a plane extending through an end of the opening such that a distance between the sealing surface and the plane increases with decreasing radial distance from the outer surface (see annotated fig. 4 below).
Given the teachings of Thibault, it would have been obvious to one of ordinary skill in the art before the time of effective filing to have an angle relative to a plane extending through an end of the opening with the invention of Eckhoff. Doing so provides a longer mating surface between the bottle flange and cap and can thereby strengthen the seal between those elements and make it more difficult for gas inside the container to leak out.
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Regarding claim 32, Eckhoff as Thibault is deemed to disclose wherein the angle is greater than 5 degrees (see annotated Thibault - fig. 4 above).
Wherein the Applicant may argue that the specific angle range is not disclosed, the Office alternatively notes that it would have been obvious to one of ordinary skill in the art before the time of effective to have the angle greater than 5 degrees. Doing so provides a longer mating surface between the bottle flange and cap and can thereby strengthen the seal between those elements and make it more difficult for gas inside the container to leak out. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art (MPEP 2144 II).
Regarding claim 33, Eckhoff as Thibault is deemed to disclose wherein the angle is less than or equal to 45 degrees (see annotated Thibault - fig. 4 above).
Wherein the Applicant may argue that the specific angle range is not disclosed, the Office alternatively notes that it would have been obvious to one of ordinary skill in the art before the time of effective to have the angles is less than or equal to 45 degrees. An angle greater than 45 degrees is the angle at which the mating surface would begin to get smaller again. Having a longer mating surface between the bottle flange and cap can strengthen the seal between those elements and make it more difficult for gas inside the container to leak out. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art (MPEP 2144 II).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckhoff (US 2015/0211950 A1) in view of Matweb-Aluminum (Aluminum, Al; https://www.matweb.com/search/DataSheet.aspx?MatGUID=0cd1edf33ac145ee93a0aa6fc666c0e0; Retrieved 16 March 2017) in view of Takahashi (US 2018/0044056 A1) in view of Ethylene-Propylene Rubbers & Elastomers, April 20, 2012, International Institute of Synthetic Rubber Producers, Inc. hereinafter referred to as EPRE.
EPRE reference cited in IDS of 16 October 2023 and provided to Applicant in parent application 17/213,922 on 17 June 2021.
Regarding claim 34, Eckhoff discloses wherein the stopper has a glass transition temperature (Tg) that is greater than or equal to −70° C. and less than or equal to −45° C (paragraph 0054 – stopper is noted that it can be made from different materials including “ethylene propylene diene monomer (EPDM) rubber” which has a glass transition temperature in the cited range).
Wherein the Applicant may argue that the stopper’s glass transition temperature is not explicitly disclosed, the Office further points to EPRE.
EPRE teaches wherein ethylene propylene diene monomer (EPDM) rubber has a glass transition temperature (Tg) that is greater than or equal to −70° C. and less than or equal to −45° C (pg. 1 – “Ethylene-proplene rubbers… have excellent low temperature flexibility with glass transition points of about minus 60° C”).
Given the teachings of EPRE, it would have been obvious to one of ordinary skill in the art before the time of effective filing to have the EPDM rubber of Eckhoff have a glass transition temperature in the cited range. EPRE demonstrates how such a glass transition temperature was a known property of EPDM rubber. This type of material has excellent flexibility at low temperature which makes it useful in cold storage settings.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckhoff (US 2015/0211950 A1) in view of Matweb-Aluminum (Aluminum, Al; https://www.matweb.com/search/DataSheet.aspx?MatGUID=0cd1edf33ac145ee93a0aa6fc666c0e0; Retrieved 16 March 2017) in view of Takahashi (US 2018/0044056 A1) in view of Kimura et al. (US 2018/0257975 A1) hereinafter referred to as Kimura.
Regarding claim 40, Eckhoff discloses wherein the sealed pharmaceutical container is constructed of a glass composition (paragraphs 0040-0041), but is silent regarding the coefficient of thermal expansion (CTE).
However, Kimura teaches a pharmaceutical container is constructed of a glass composition having a coefficient of thermal expansion (CTE) that is greater than or equal to 30×10−7/K and less than or equal to 70×10−7/K (Abstract; paragraphs 0001 and 0095).
Given the teachings of Kimura, it would have been obvious to one of ordinary skill in the art before the time of effective filing to have the glass composition of Eckhoff have a CTE of the claimed range as taught by Kimura. Both are concerned with the problem of having a pharmaceutical container constructed of glass. Doing so would allow for the glass to have a good thermal shock resistance.
Response to Arguments
Applicant's arguments filed 15 December 2025 have been fully considered but they are not persuasive.
The Office maintains their rejection under 35 USC 112b with regards to claim 30 and the dependent claims. The Applicant’s arguments are not deemed to address the underlying issue. This issue is that what is being claimed is not a method step, but rather a motivation for choosing a value of surface roughness. There is a positively recited step of “providing a sealed pharmaceutical container comprising… a flange…the flange comprising:… a sealing surface… wherein the sealing surface has a surface roughness of less than or equal to 0.1 μm”. This is the physical step being performed.
The claim then goes on to recite, “wherein the surface roughness of the sealing surface is predetermined based on an estimated shrinkage of the sealing assembly associated with the glass container when the sealing assembly is cooled to temperatures less than or equal to -80°C”. This is a motivation for why the value of the method step was chosen. This reasoning is not presented in the claim as having been performed by a controller or other device that selects the surface roughness during the procurement of the container. This language can be deemed to be effectively claiming what the mental process (i.e. motivation) is for a human selecting a container’s surface roughness is prior to the claimed method being performed.
An internal motivation for performing a method step, is not germane to patentability when it comes to applying prior art. The prior art only needs to demonstrate that the method steps are anticipated or made obvious to one of ordinary skill prior to the time of effective filing. That the prior art may have different reasons for arriving at the same method is not disqualifying of the prior art or combination thereof.
That the determination is based on a mathematical formula is also not germane. Mentally carrying out mathematical operations is not patent eligible subject matter. The claim’s ambiguity as to how this predetermination is happening does not preclude such mental processes by a human operator and as such the cited limitation is deemed to be indefinite.
With regards to the 35 USC 103a rejections of claim 30, the Office generally points to the responses in the paragraph above as it pertains to the 35 USC 112b rejections. The prior art of Eckhoff and Takahashi is deemed to disclose a sealing surface has a surface roughness of less than or equal to 0.1 μm and wherein the surface roughness of the sealing surface is predetermined based on an estimated shrinkage of the sealing assembly associated with the glass container when the sealing assembly is cooled to temperatures less than or equal to -80°C (Eckhoff – paragraph 0098; Takashi – paragraphs 0074-0075; see 35 USC 112b above). The Applicant has also not traversed the Office’s assertion that it would have been obvious to one of ordinary skill in the art at the time of effective filing to have the surface roughness of Eckhoff as modified by Takahashi be less than or equal to 0.1 μm. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. (In re Aller, 105 USPQ 233; MPEP 2144.05 I and II).
The Office deems the prior art to disclose the recited method steps for the reasons provided above. The limitations regarding the reasoning why the surface roughness is chosen is deemed to be indefinite as it appears to claim an internal mental process and motivation which is not materially carried out as part of the method and/or otherwise includes patent-ineligible subject matter.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW M TECCO whose telephone number is (571)270-3694. The examiner can normally be reached M-F 11a-7p.
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/ANDREW M TECCO/Primary Examiner, Art Unit 3731