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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 and 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application No. 14/075630 and 61/731767, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Please see 112(a) rejections in section 5 below.
Specification
The Abstract filed 2/27/2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
In the Abstract the limitations of a "coated glass package", a "lubricous coating having a thickness of ≤100 microns", a "coefficient of friction that is at least 20% less than an uncoated glass package", the "coefficient of friction does not increase by more than 30% after undergoing depyrogenation", a horizontal compression strength that "is at least 10% greater than an uncoated glass package", and the horizontal compression strength "is not reduced by more than 20% after depyrogenation" do not find support in the parent application as originally filed. Please see 112(a) new matter rejections for claim 1 below for an explanation.
Applicant is required to cancel the new matter in the reply to this Office Action.
The disclosure is objected to because of the following informalities:
In [0075], the term “the glass package” is objected to grammatically as the phrase lacks antecedent basis in the specification. This objection can be overcome by changing the phrase to “the glass container”.
In [0076], the term “the package” is objected to grammatically as the phrase lacks antecedent basis in the specification. This objection can be overcome by changing the phrase to “the glass container”.
Appropriate correction is required.
Claim Objections
Claim 11 is objected to because of the following informalities:
In claim 11, the phrase “the coefficient of friction is a maximum” is objected to grammatically. This objection can be overcome by changing the phrase to “the coefficient of friction of the coated glass pharmaceutical package is a maximum” which is how the claim will be interpreted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-15 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for specific inorganic materials that can generate a lubricous coating having the functional limitations claimed, does not reasonably provide enablement for any layer, known or that has yet to be invented, that comprises any inorganic material that has the functional limitations claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Case law holds that applicant’s specification must be “commensurately enabling [regarding the scope of the claims]” Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1990). Otherwise undue experimentation would be involved in determining how to practice and use applicant’s invention. The test for undue experimentation as to whether or not all compounds within the scope of claims 1-15 can be used as claimed and whether claims 1-15 meet the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed.Cir. 1988). Upon applying this test to claims 1-15, it is believed that undue experimentation would be required because:
(a) The quantity of experimentation necessary is great since claims 1-15 read on any tenacious inorganic lubricous coating that possesses the functional limitations claimed. There would be undue experimentation to test all types of tenacious inorganic lubricous coatings to determine which ones would possess the functional limitations claimed. There would be undue experimentation to test all of the known inorganic materials other than those at [0203] to figure out which may possess the functional limitations claimed.
(b) The breadth of the claims are drawn to any possible tenacious inorganic lubricous coating comprising a tenacious inorganic coating that possesses the functional limitations claimed. Applicants’ specification is not enabling for any possible tenacious inorganic coating comprising any material that is known or has yet to be invented that has the functional limitations claimed.
It is noted that the scope of the claims are so broad that it would encompass any tenacious inorganic material. At best, applicants have mentioned specific classes of inorganic materials at [0203], and therefore this means that the claims are not enabled for scope of materials described in the specification as there is no way for one of ordinary skill to know what materials other than inorganic materials classes or specific materials mentioned at [0203] would have the functional limitations claimed.
(c) The working examples, only discuss four specific polymer compounds, i.e. Novastrat 800, Kapton, DC806A, and DC255. These four specific compounds, i.e. only two classes of polymers, would not be sufficient to inform one of ordinary skill in the art to know in what direction to experiment for the tenacious inorganic materials as the lubricous coating in order to determine what materials would possess or do not possess the functional limitations claimed. One of ordinary skill in the art would have had undue experimentation to predict any chemical within the realm of a tenacious inorganic "lubricous coating" that would meet the functional limitations claimed.
In light of the above factors, it is seen that undue experimentation would be necessary to make and use the invention of claims 1-15.
Claims 1-15 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 1-10, the Examiner does not find support for the limitations of a "coated glass package" in the specification as originally filed. The language in the specification relates to a "coated glass container" or a "pharmaceutical package" which are both more specific than a generic "package" as is claimed.
In claim 1, the Examiner does not find support for the limitations of a "lubricous coating having a thickness of ≤100 microns" in the specification as originally filed. The language in the body of the current specification and the parent application refers to "less than…100 microns" [0216].
In claims 1 and 11, the Examiner does not find support for the limitations that the "coefficient of friction that is at least 20% less than an uncoated glass package" in the specification as originally filed. The coefficient of friction in this instance is being compared to any uncoated glass, which does not find support in the specification or parent application as originally filed. It is clear from [0174] that this is measured relative to "an uncoated glass container formed from the same glass composition" and not relative to any glass composition.
In claims 1, the Examiner does not find support for the limitations that the "coefficient of friction does not increase by more than 30% after undergoing a depyrogenation cycle", respectively, in the specification as originally filed. These limitations draw the closest support from [0175]; however, this section does not mention any generic "depyrogenation cycle", and therefore there is no support to have a generically claimed "depyrogenation cycle".
In claims 1 and 11, the Examiner does not find support for the limitations that the horizontal compression strength "is at least 10% greater than an uncoated glass package" in the specification as originally filed. The horizontal compression strength in this instance is being compared to any uncoated glass package, which does not find support in the specification as originally filed. Based on the context of [0174] and [0180], this is measured relative to "an uncoated glass container formed from the same glass composition" and not relative to any glass composition.
In claim 1, the Examiner does not find support for the limitations that the horizontal compression strength "the horizontal compression strength is not reduced by more than 20% after undergoing the depyrogenation cycle" in the specification as originally filed. These limitations draw the closest support from [0182]; however, this section does not mention any generic "depyrogenation cycle", but rather has a "heat treatment" along with abrading the glass container after the heat treatment, and therefore there is no support to have a generically claimed "depyrogenation cycle" or leaving out the testing of the abraded glass container.
In claims 6 and 8, the Examiner does not find support for the limitations “at least” 250 C or 260 C in the specification as originally filed. It is clear from at least [0166] that depyrogenaton is performed within a range of temperatures or at about certain specific temperatures, and is not disclosed as an open-ended temperature range.
In claims 6, 8, and 9, the Examiner does not find support for the phrases "for at least 30 minutes" and "of at least 30 minutes" in the specification as originally filed. This is an open-ended range, which was not supported by the specification as originally filed. It is clear from [0166] and [0175] that the time period of depyrogenation is not open-ended.
Claims 1-15 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 pre-AIA the applicant regards as the invention.
In claims 1, 7 and 11, the phrases "is at least 10% greater than an uncoated glass package" (claim 1), "an uncoated glass package" (claim 7), and "is at least 10% greater than an uncoated glass pharmaceutical package" (claim 11), respectively, render the claims indefinite because it is unclear if this would be a glass container made from the same glass composition as the coated glass container. The claim seems to suggest this but the lack of clarity renders the claim indefinite. The rejection can be overcome by changing each claim to include the limitations "formed from the same glass composition" which is how the claims will be interpreted.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In claim 2, the limitations that the coefficient of friction is "≤ 0.7" fails to limit the claim from which it depends because the term "lubricous coating" in claim 1 has a specific definition set forth at [0173]. This paragraph defines that in "the embodiments described herein, the portion of the coated glass container with the lubricous coating has a coefficient of friction of less than or equal to about 0.7 relative to a like-coated glass container". This means that claim 2 fails to limit the claim from which it depends because these limitations are already within claim 1.
Claim Rejections - 35 USC § 103
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bicker et al. (US 2009/0155490) as evidenced by "Schott Technical Glasses" acquired from (http://www.us.schott.com/tubing/english/download/schott-brochure-technical-glasses_us.pdf).
Please note that the term "lubricous coating" and how the "coefficient of friction" is measured is defined at [0173]-[0177].
With regard to claims 1-15, Bicker et al. teach the treatment of glass hollow containers on both the inside and outside for pharmaceutical packaging [0001], [0016], and [0029]. The glass can be Fiolax glass and the coating can be SiOx among other materials, which read on applicants' tenacious inorganic coating [0027] and [0044]. Applicants state at [0125] of their specification that "Schott Fiolax" is a known Type I borosilicate glass for pharmaceutical packaging. The coating can be deposited at thicknesses greater than 5 nanometers [0027]; however, Bicker et al. do not specifically teach using the Fiolax glass with SiO2 coatings having the properties claimed.
It would have been obvious to one having ordinary skill to have made a Fiolax glass container with SiO2 coatings on the surfaces of the container having the thickness claimed as these are known materials in Bicker et al. for forming pharmaceutical containers and the thickness of the coating overlaps with the claimed range; hence, a prima facie case of obviousness exists.
Given the fact that Bicker et al. teach a pharmaceutical container having a glass composition and a tenacious inorganic coating identical to that claimed, the coated container of Bicker et al. will intrinsically possess the coefficient of friction, the coefficient of friction difference, the coefficient of friction change after undergoing a depyrogenation cycle at the conditions claimed, the horizontal compression strength difference, the horizontal compression strength change after undergoing a depyrogenation cycle at the conditions claimed and light transmission after depyrogenation as claimed.
With specific regard to claims 1, 11 and 15, as evidenced by pages 29-30 of "Schott Technical Glasses", the Fiolax brand neutral borosilicate pharmaceutical glass will meet each of the ISO 695, ISO 719, and DIN 12116 requirements and meet the pharmacopoeia standards in Europe and various other nations.
Given all of this evidence, it is the position of the Examiner that the Schott Fiolax glass will meet the Type 1 chemical durability according to USP 660, the Type 1 glass composition standard according to ASTM E438-92, the alkali resistance according to ISO 695, the hydrolytic resistance according to ISO 719, and the acid resistance according to DIN 12116 absent objective evidence to the contrary.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bicker et al. (US 2009/0155490) in view of Brix (US 2011/0098172).
Please note that the Examiner is interpreting the phrases "lubricous coating" and "coefficient of friction" as explained above.
With regard to claims 1-5, 12-14, 16-20, 23-27, 34, 113, 115, and 116, Bicker et al. teach the treatment of glass hollow containers on both the inside and outside for pharmaceutical packaging [0001], [0016], and [0029]. The glass can be coated with SiOx among other materials, which read on applicants' tenacious inorganic coating [0027] and [0044]. The coating can be deposited at thicknesses greater than 5 nanometers [0027]; however, Bicker et al. do not specifically teach using aluminosilicate glass with SiO2 coatings with properties claimed.
Brix teaches a boron-free, zinc-free, phosphorous-free neutral glass that may be used as a packaging container for pharmaceutical products [0002]. Specifically, see Example B2 of Table 3 [0073]. The material may be comprise Na2O, CaO, and MgO along with the bulk being silica and alumina [0027]. The glass may have class 1 hydrolytic resistance according to ISO 719, class 2 acid resistance according to DIN 12116, and class 2 alkali resistance according to ISO 695 [0027].
Since Bicker et al. and Brix are both drawn to glass containers for pharmaceuticals; it would have been obvious to one having ordinary skill in the art to have used the glass containers of Brix as the glass containers of Bicker et al. This would be mere substitution for a known material for a known purpose. Additionally, it would have been obvious to have made the thickness of the coating the same as that claimed as there is an overlap in the thickness of the prior art with the thickness claimed; hence, a prima facie case of obviousness exists.
Given the fact that Bicker et al. in view of Brix teach a pharmaceutical container having a glass composition, a tenacious inorganic coating and a barrier coating identical to that claimed, the coated container of Bicker et al. in view of Brix will intrinsically possess the coefficient of friction, the coefficient of friction difference, the coefficient of friction change after undergoing a depyrogenation cycle at the conditions claimed, the horizontal compression strength difference, the horizontal compression strength change after undergoing a depyrogenation cycle at the conditions claimed and light transmission after depyrogenation as claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 and 61-65 US Patent No. 10307333.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to glass pharmaceutical containers comprising a body of glass having a coating, wherein the copending lubricious coatings, i.e. tenacious inorganic, read on the presently claimed lubricous coatings having the same coefficient of friction. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach the coefficient of friction, the DIN 12116/ISO 695/ISO 719/USP 660 resistances, Type IB ASTM E438-92 glass, the thermal stability, and a tenacious inorganic layer; however, the copending independent claims do not specifically teach the relative coefficient of friction, coefficient of friction change after depyrogenation or heating, the relative horizontal compression strength, the horizontal compression strength change after depyrogenation, the light transmission after depyrogenation, or the thickness claimed.
Applicant’s attention is drawn to MPEP 804 where it is disclosed that “the specification can always be used as a dictionary to learn the meaning of a term in a patent claim.” In re Boylan, 392 F.2d 1017, 157 USPQ 370 (CCPA 1968). Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in an application defines an obvious variation of an invention claimed in the patent. (underlining added by examiner for emphasis) In re Vogel, 422 F.2d 438,164 USPQ 619,622 (CCPA 1970).
Consistent with the above underlined portion of the MPEP citation, attention is drawn to [0170]-[0186], and [0201] of the specification of 14/075620 which defines what is meant by the lubricous layer, including its relative coefficient of friction and coefficient of friction change after depyrogenation or heating, what is meant by the glass container, including its relative horizontal compression strength, the horizontal compression strength change after depyrogenation, and the light transmission after depyrogenation, and what is meant by the glass body and its' properties; therefore, it would have been obvious to one of ordinary skill in the art to have made the coating, the glass body, and the glass container have the same properties as currently claimed. Additionally, it would have been obvious to have made the thickness of the coating any amount, including less than 100 microns as claimed in order to have the coefficient of friction without adding so much as to have excess coating that wastes money.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-28 of US Patent No. 10023495.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to glass containers comprising a body of glass having a tenacious inorganic lubricous coating, wherein the copending lubricious coatings reads on a coating having the same coefficient of friction. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach the coefficient of friction, Type IB ASTM E438-92 glass, the thermal stability, and materials that read on a tenacious polymer layer; however, the copending independent claims do not specifically teach the other glass properties, the relative coefficient of friction, coefficient of friction change after depyrogenation or heating, the relative horizontal compression strength, the horizontal compression strength change after depyrogenation, the light transmission after depyrogenation, or the thickness claimed.
Applicant’s attention is drawn to MPEP 804 where it is disclosed that “the specification can always be used as a dictionary to learn the meaning of a term in a patent claim.” In re Boylan, 392 F.2d 1017, 157 USPQ 370 (CCPA 1968). Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in an application defines an obvious variation of an invention claimed in the patent. (underlining added by examiner for emphasis) In re Vogel, 422 F.2d 438,164 USPQ 619,622 (CCPA 1970).
Consistent with the above underlined portion of the MPEP citation, attention is drawn to [0156]-[0162], [0166]-[0182], [0197], and [0198] of the specification of 14/075630 which define what is meant by the lubricous layer, including its relative coefficient of friction and coefficient of friction change after depyrogenation or heating, what is meant by the glass container, including its relative horizontal compression strength, the horizontal compression strength change after depyrogenation, and the light transmission after depyrogenation, and what is meant by the glass body and its' properties; therefore, it would have been obvious to one of ordinary skill in the art to have made the lubricous coating, the glass body, and the glass container have the same properties as currently claimed. Additionally, it would have been obvious to have made the thickness of the coating any amount, including less than 100 microns as claimed in order to have the coefficient of friction without adding so much as to have excess coating that wastes money.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 and 54-65 of US Patent No. 10117806.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to glass containers comprising a body of glass having a coating, wherein the copending inorganic lubricious coatings reads on the claimed inorganic lubricous coating having the same coefficient of friction. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach the coefficient of friction, the DIN 12116/ISO 695/ISO 719/USP 660 resistances, Type IB ASTM E438-92 glass, and a tenacious inorganic layer; however, the copending independent claims do not specifically teach the relative coefficient of friction, coefficient of friction change after depyrogenation or heating, the relative horizontal compression strength, the horizontal compression strength change after depyrogenation, the light transmission after depyrogenation, or the thickness claimed.
Applicant’s attention is drawn to MPEP 804 where it is disclosed that “the specification can always be used as a dictionary to learn the meaning of a term in a patent claim.” In re Boylan, 392 F.2d 1017, 157 USPQ 370 (CCPA 1968). Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in an application defines an obvious variation of an invention claimed in the patent. (underlining added by examiner for emphasis) In re Vogel, 422 F.2d 438,164 USPQ 619,622 (CCPA 1970).
Consistent with the above underlined portion of the MPEP citation, attention is drawn to [0168]-[0184], [0199], and [0200] of 14/075593 which define what is meant by the lubricous layer, including its relative coefficient of friction and coefficient of friction change after depyrogenation or heating and what is meant by the glass container, including its relative horizontal compression strength, the horizontal compression strength change after depyrogenation, and the light transmission after depyrogenation; therefore, it would have been obvious to one of ordinary skill in the art to have made the lubricous coating, the glass body, and the glass container have the same properties as currently claimed. Additionally, it would have been obvious to have made the thickness of the coating any amount, including less than 100 microns as claimed in order to have the coefficient of friction without adding so much as to have excess coating that wastes money.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERARD T HIGGINS whose telephone number is (571)270-3467. The examiner can normally be reached M-F 9:30-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Ruthkosky can be reached at (571) 272-1291. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gerard Higgins/Primary Examiner, Art Unit 1785