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 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 application, Application No. 14/075620, fails 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) rejection in section 4 below for an explanation.
Claim Objections
Claims 2 and 11 are objected to because of the following informalities:
In claims 2 and 11, the limitations of “such that the glass container with the coating” is objected to grammatically as the coating is placed onto the glass body. The objection can be overcome by changing the limitations to “such that the glass body with the coating” which is how the claim will be interpreted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 2-9 and 11-18 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 2, 3, 11 and 12, the Examiner does not find support for the limitations of “a coating” having the thickness and coefficient or friction claimed in the specification as originally filed. This coating is referred to as a “lubricous coating” and not a generic coating as claimed, see e.g. [0010] or [0167].
In claims 4 and 13, the Examiner does not find support for the limitations of the coefficient of friction does not increase by more than 30% “after a depyrogenation cycle” in the specification as originally filed. The closest support for these limitations is at [0179]; however, there is no support for the 30% increase range under any depyrogenation conditions.
In claims 5 and 14, the Examiner does not find support for the limitations of the depyrogenation cycle conditions of “at least 250 C for at least 30 minutes” in the specification as originally filed. The closest support for these limitations is at [0170] and [0179], but there is no support for the open-ended ranges.
In claims 6 and 15, the Examiner does not find support for the limitations of the depyrogenation cycle conditions of “at least 250 C for up to 72 hours” in the specification as originally filed. The closest support for these limitations is at [0170] and [0179], but there is no support for the ranges being “at least” 250 C and “up to” 72 hours.
In claims 8, 9, 17 and 18, the Examiner does not find support for the concept of a “after a lyophilization cycle” in the specification as originally filed. The closest support for these limitations is at [0181]; however, “exposure to lyophilization conditions” would not support the concept of a “lyophilization cycle” as this is not a mere rephrasing.
Claims 1-18 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.
In claims 1 and 10, the limitations that the interior surface of the glass container consists of “a Type 1 glass composition according to ASTM Standard E438-92(2011)” renders the claim indefinite as there is no such glass composition according to that ASTM standard. The rejection can be overcome by changing the phrase to “a Type I glass composition according to ASTM Standard E438-92(2011)” which is how the claim will be interpreted.
In claim 10, the limitations that the interior surface of the glass container consists of a Type I glass that “comprises one or more of SiO2, B2O3, Al2O3, alkali oxides, alkaline oxides, and fining agents” with the requirement that the Type I glass composition “is a borosilicate” renders the claim indefinite because the first limitation requires only one of the silica or boric oxide in the glass while the second limitation would require both in the glass as a borosilicate. This does not make sense. The rejection can be overcome by deleting the first limitation, which is how the claim will be interpreted.
Claim Rejections - 35 USC § 102
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perrot (US 2012/0061342).
With regard to claims 1 and 10, Perrot discloses a coated glass bottle that is suitable for packaging pharmaceuticals that may comprise a borosilicate/Pyrex or a type I glass [0030], [0037], and [0038]. As can be seen in Figure 1, the container has a wall portion, heel portion and a floor portion. Teaching that it may package a pharmaceutical substance necessarily teaches applicants’ limitations of a pharmaceutical formulation stored within the glass body [0030]. The coating on the outside face may be a silicone that is substantially transparent [0041], [0047], and [0048].
Given the fact that the bottle is made from the same type of glass and polymer as is preferentially disclosed in applicants' specification and the fact that the container may be used for pharmaceuticals, it is the position of the Examiner that the article of Perrot will intrinsically meet the type 1 criteria according to USP <660>, the base resistance, and the hydrolytic resistance claimed. Lastly, since there is no coating on the interior surface of the container, the interior surface of the container will consist of the Type I glass composition and will not comprise a boron-rich layer as claimed.
Claim Rejections - 35 USC § 103
Claims 1, 2, 4-11 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Romberg et al. (4,882,210) in view of "European Pharmacopoeia 5.0" (http://pharmacyebooks.com/2009/09/european-pharmacopoeia-5-0-online.html, pg. 303) as evidenced by "Parylene Conformal Coating Specifications & Properties" (https://www.nbtc.cornell.edu/sites/default/files/Parylene%20Information%20Sheets.pdf).
With regard to claims 1, 2, 4-11 and 13-18, Romberg et al. disclose polyparaxylylene coatings, i.e. Parylene N, on the outside of glass containers meant for pharmaceuticals (col. 3, lines 54-66 and col. 4, lines 23-32). The glass container in the form of a bottle or jar will necessarily have a wall portion, heel portion and floor portion (col. 2, lines 49-56). Teaching that it is suited for pharmaceutical drug containers necessarily teaches applicants’ limitations of a pharmaceutical formulation stored within the glass body (col. 2, lines 37-40). The thickness of the coating may be 1 to 3 microns (col. 2, lines 33-37); however, Romberg et al. do not disclose what type of glass to use for the pharmaceutical container.
The "European Pharmacopoeia 5.0" standard for pharmaceutical containers teaches that the containers may be a Type I colourless glass container that is borosilicate glass (pg. 303).
Since Romberg et al. and the "European Pharmacopoeia 5.0" 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 known borosilicate glass for pharmaceuticals as the glass container of Romberg et al. This is a mere substitution of a known material for a known purpose.
As evidenced by "Parylene Conformal Coating Specifications & Properties", Parylene N has a coefficient of friction of 0.25 (Table 3), a melting point of 420 C (Table 4), and is transparent and colorless in the visible region (pg. 8).
Given all of this evidence, it is the position of the Examiner that the Parylene N coatings of Romberg et al. in view of "European Pharmacopoeia 5.0" would intrinsically meet the coefficient of friction, the coefficient of friction change after a depyrogenation cycle using the conditions claimed, the coefficient of friction change after a lyophilization cycle using the conditions claimed, the type 1 criteria according to USP <660>, the base resistance, and the hydrolytic resistance claimed. Lastly, since there is no coating on the interior surface of the container, the interior surface of the container will consist of the Type I glass composition and will not comprise a boron-rich layer 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9034442.
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 formed from Type glass according to ASTM E438-92 with a compressive stress layer. The present claims are broad enough to have all of the other limitations of the copending claims; however, the copending claims do not specifically teach the resistances 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 col. 15-22 and col. 31-32 of US 9034442 which define what is meant by the glass body, including chemical durability according to ISO 695, ISO 719, and USP <660> claimed; therefore, it would have been obvious to one of ordinary skill in the art to have made the glass body of the patented claims have the structure and properties as currently claimed.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23, 28-54 and 61-65 of U.S. Patent No. 10,117,806.
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 borosilicate glass. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach the Type IB ASTM E438-92 glass, the ISO 719 resistance, the ISO 695 resistance, and the Type 1 USP <660> durability; however, the copending independent claims do not specifically teach the properties in the independent claims.
It would have been obvious to one having ordinary skill to have made the copending independent claims be glass body having the same materials and properties as the glass body defined within the dependent copending claims.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,507,164.
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. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach Type IB ASTM E438-92 glass, the ISO 695 resistance, the ISO 719 resistance, and the USP <660> durability. The copending claims are a species of the pending claims, and therefore they render the pending claims obvious based on the anticipation type analysis, see MPEP 804.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,023,495.
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. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach Type IB ASTM E438-92 glass; however, the copending claims do not specifically teach the ISO 695 resistance, the ISO 719 resistance, and the USP <660> durability 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 [0104], [0110]-[0120], and [0156]-[0162] of as-filed specification of U.S. Patent No. 10,023,495 which define what is meant by the glass container, including the ISO 695 resistance, the ISO 719 resistance, and the USP <660> durability; therefore, it would have been obvious to one of ordinary skill in the art to have made the glass container have the same structure and properties as currently claimed.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-65 of U.S. Patent No. 10,307,333.
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. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach Type IB ASTM E438-92 glass, the ISO 695 resistance, the ISO 719 resistance, and the USP <660> durability claimed; however, the copending claims do not specifically teach them in the same independent claim.
It would have been obvious to one having ordinary skill to have made the copending independent claims be glass body having the same materials and properties as the glass body defined within the dependent copending claims.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,307,334.
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. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach Type I ASTM E438-92 glass, the ISO 695 resistance, the ISO 719 resistance, and the USP <660> durability. The copending claims are a species of the pending claims, and therefore they render the pending claims obvious based on the anticipation type analysis, see MPEP 804.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,786,431.
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. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach Type I ASTM E438-92 glass, the ISO 695 resistance, the ISO 719 resistance, and the USP <660> durability. The copending claims are a species of the pending claims, and therefore they render the pending claims obvious based on the anticipation type analysis, see MPEP 804.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,813,835.
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. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach borosilicate glass that meets the USP <660> durability and has no interior coating; however, the copending claims do not specifically teach the ISO 695 resistance and the ISO 719 resistance 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 col. 32 and 33 of U.S. Patent No. 10,813,835 which define what is meant by the glass container, including the ISO 695 resistance and the ISO 719 resistance; therefore, it would have been obvious to one of ordinary skill in the art to have made the glass container have the same structure and properties as currently claimed.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,951,072.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both drawn to glass containers/packages comprising a body of glass. The present claims are broad enough to have all of the other limitations of the copending claims. The copending claims teach Type I ASTM E438-92 glass, the ISO 695 resistance, the ISO 719 resistance, and the USP <660> durability. The copending claims are a species of the pending claims, and therefore they render the pending claims obvious based on the anticipation type analysis, see MPEP 804.
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
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