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 .
Summary
This Office Action sets forth a new grounds of rejection on unamended claims (namely, 35 U.S.C. 103 rejection of previously-allowable claims 11 and 12). Accordingly, this Office Action is being made Non-Final.
Therefore, the previous Office Action mailed 30 June 2026 has been withdrawn in lieu of the one presented below.
Claim(s) 1-14 is/are currently pending and considered.
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.
Claim(s) 13 is/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.
Regarding claim 13, introduction of “wherein the filling line has less stoppages over 8 hours than a filling line without the polymer composition” renders the claim indefinite because the limitation as written compares stoppages of the filling line to another filling line without the polymer composition without factoring in any other conditions (are the two filling lines identical other than the polymer coating? Does this comparison factor in possible operator errors?), making the scope of claimed limitation confusing. For the purposes of examination, the prior art is considered to have less stoppages of at least one filling line in existence.
Claim Rejections - 35 USC § 103
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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 6, and 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bookbinder (US 2017/0320773 A1) in view of Bayne (US 2016/0251260 A1).
Regarding claim 1, Bookbinder discloses a pharmaceutical filling line (“vials were prepared and run through a pharmaceutical filling line”, para 269) comprising:
an accumulator table (300);
a wash station (“washing”, para 169);
a filling station (“filling” para 171); and
wherein the accumulator table, the wash station, the filling station and the capping station each have a plurality of contact points with pharmaceutical containers loaded onto the pharmaceutical filling line (“A pressure sensitive tape (commercially available from Fujifilm) was inserted in between the vials to measure contact/impact forces between the vials and between the vials and the equipment.” Para 269; see also Figs. 36-37 and 39 showing friction between the coating and the equipment; see also Fig. 9 for multiple contact points); and
wherein at least some of the contact points are coated with a polymer chemical composition (para 269).
Bookbinder does not disclose the filling line comprising a capping station.
However, Bayne discloses a filling line comprising a capping station (“capping operations, para 181).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filling date of the claimed invention to have modified the filling line, as disclosed by Bookbinder, to comprise a capping station, as taught by Bayne, with the motivation to apply caps to the vials.
Regarding claim 2, modified Bookbinder discloses the pharmaceutical filling line of claim 1, the polymer chemical composition having a coefficient of friction of 0.7 or less (0.25; para 269).
Regarding claim 6, modified Bookbinder discloses the pharmaceutical filling line of claim 1, further comprising a star wheel (Bayne, “star wheels” para 6 and 128).
Regarding claim 8, modified Bookbinder discloses the pharmaceutical filling line of claim 1, further comprising a screw feeder (Bayne, 750) and a stationary guide (“stationary guide”, para 183).
Regarding claim 9, modified Bookbinder discloses the pharmaceutical filling line of claim 8, wherein at least some of the contact points are on the stationary guide (“Lateral loads on the containers are generally proportional to the number of containers between a stationary guide” para 183) and the screw feeder (see Fig. 58).
Regarding claim 10, modified Bookbinder discloses the pharmaceutical filling line of claim 8, wherein the pharmaceutical containers comprise a coating that comprises a polymer coating having a coefficient of friction less than or equal to 0.7 (Bookbinder – coefficient of friction of 0.25, para 269).
Regarding claims 11 and 12, modified Bookbinder discloses the pharmaceutical filling line of claim 10.
Bookbinder does not explicitly disclose wherein the polymer composition of the contact points is either the same as or different from the polymer composition of the coating.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the polymer composition of the contact points of modified Bookbinder to either be the same as or different from the polymer composition of the coating, since it would have been “obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. See MPEP2143-I.E. Specifically, there are only two identified, predictable solutions – same composition or different compositions of the two polymer compositions – and one having ordinary skill in the art would have a reasonable expectation of success.
Regarding claim 13, modified Bookbinder discloses the pharmaceutical filling line of claim 1, wherein the filling line has less stoppages over 8 hours than a filling line without the polymer composition (see 112(b) rejection above.
Claim(s) 3-5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bookbinder (US 2017/0320773 A1) in view of Hubertus (BR 112012022778 B1 – see machine translation mailed previously), further evidenced by Subject Application PG Pub. US 2026/0048880 A1)
Regarding claim 3, modified Bookbinder discloses the pharmaceutical filling line of claim 2.
Bookbinder does not explicitly disclose wherein the pharmaceutical filling line operates at an efficiency rate of at least 70 percent when set at a minimum operating speed of 600 containers per minute.
However, Hubertus discloses an analogous filling line capable of operating a pharmaceutical filling line (filling line 100 that fills glass containers 110 – “Containers 10, however, can also be in the form of cans, boxes, bags, glasses, buckets, drums, or any other type” – with “over the counter (or otherwise) medicines such as acetaminophen and similar types of materials” translations p. 4 para 2) at a minimum operating speed of 600 containers per minute (“The potting line 100, therefore, can fill about 600 to about 800 containers per minute or more.” P. 7 para 2). Since the filling lines of Bookbinder and Hubertus are analogous, one having ordinary skill in the art would expect that the filling line of Bookbinder, which is silent on the operating speed, would be able to operate at the same or similar speed as Hubertus. Furthermore, one having ordinary skill in the arts in view of Hubertus would recognize that the method of Bookbinder can be benefited from the minimum operating speed of 600 containers or more, as disclosed by Hubertus, in order to meet high demands of products.
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filling date of the claimed invention to have modified the method, as disclosed by Bookbinder, to operate the pharmaceutical filling line at a minimum operating speed of 600 containers per minute, as taught by Hubertus, with the motivation to allow high speed production in order to meet demands. Note that the combination of Bookbinder and Hubertus would result in the step of receiving filled pharmaceutical containers from an output of the pharmaceutical filling line at an efficiency rate of at least 70 percent, since 1) one having ordinary skill in the art would recognize that the pharmaceutical filling line of Bookbinder in view of Hubertus yields to essentially the same filling line of Subject Application, and 2) the vials disclosed by Bookbinder was formed from the Reference Glass Composition and was coated with a low-friction polyimide based coating having a coefficient of friction of about 0.25 (Bookbinder para 269), which is far below the coefficient of friction of 0.7, which is the coefficient of friction requirement to yield the efficiency rate of at least 70 percent at the filling line set speed (vials per minute, vpm) of over 600 containers per minute, as evidenced by Subject Application (Figs. 58-69 and para 379-381 of Subject Application PG Pub. US 2023/0087680 A1).
Regarding claim 4, modified Bookbinder discloses the pharmaceutical filling line of claim 3, the pharmaceutical containers having an exterior surface at least partially coated with the polymer chemical composition (“the coated vials” para 269).
Regarding claim 5, modified Bookbinder discloses the pharmaceutical filling line of claim 4 further comprising a depyrogenation station operating at a temperature of at least 260° C., the polymer chemical composition being thermally stable when continuously exposed to the depyrogenation station (Bookbinder – “depyrogenation”, para 169; above 260 degrees as shown in para 170).
Regarding claim 14, modified Bookbinder discloses the pharmaceutical filling line of claim 3.
Bookbinder does not explicitly disclose wherein the efficiency rate is sustained for a minimum period of 2 hours.
However, Hubertus discloses that “the potting systems 100 described in this document can operate continuously for about 96 hours or more”, (translation p. 10, first paragraph). One having ordinary skill in the art in view of Bookbinder and Hubertus would recognize that the efficiency rate of a filling line is to be sustained for the entire duration of the filling operation in order to meet high demand, reduce downtime, and sustain low waste.
Therefore, given the information that the filling line as disclosed by Bookbinder in view of Hubertus can operate at an efficiency rate of at least 70 percent and for about 96 hours or more, it would have been obvious to one with ordinary skill in the art before the effective filling date of the claimed invention to understand that the efficiency rate, as disclosed by modified Bookbinder, can be sustained for a minimum period of 2 hours, as disclosed by Hubertus, in order to produce a target throughput through the entire duration of the filling operation.
Allowable Subject Matter
Claim(s) 7 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The claims in this application have been allowed because the prior art of record fails to disclose or make obvious the claimed invention including the following features:
Claim 7, “ wherein the star wheel comprises an inner stationary guide and an exterior station guide, and wherein the at least some of the contact points are on the inner stationary guide and the exterior station guide.”
The combination of the claimed limitations are novel and found to be allowable over the prior art. The cited references taken singly or in combination do not anticipate or make obvious the Applicant's claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (See PTO-892 Notice of References Cited).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Himchan Song whose telephone number is (571)272-4142. The examiner can normally be reached M-Th 9:00 a.m. - 4:30 p.m.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at (571) 270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HIMCHAN SONG/Examiner, Art Unit 3731
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