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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/23/2024, 07/15/2025, 03/17/2026, 07/17/2026, and 07/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Applications No. 18/414,400-Bott, 18/414,584-Bott, and 18/414,587-Bott. Although the claims at issue are not identical, they are not patentably distinct from each other because they are anticipated by the copending applications previously mentioned.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant Application
Application No. 18/414,400
Application No. 18/414,584
Application No.
18/414,587
1. Production facility, in particular for producing biological-pharmaceutical products, wherein the production facility comprises the following: - a clean-room area; - a lock device for feeding an object from an environment of the production facility into the clean-room area and/or for removing an object from the clean-room area; - a handling device for moving the object within the clean-room area; - a storage device arranged within the clean-room area, which comprises a plurality of storage locations for receiving a plurality of objects.
1. A production system, in particular for producing biological-pharmaceutical products, wherein the production system comprises:
a clean room region;
an airlock device for supplying an object from the surroundings of the production system into the clean room region and/or for removing an object from the clean room region;
a handling device for moving the object within the clean room region;
a storage device which is arranged within the clean room region and which comprises a plurality of storage spaces for receiving a plurality of objects.
1. Production facility, in particular for producing biological-pharmaceutical products, the production facility comprising:
a clean-room area;
a lock device for feeding an object from an environment of the production facility into the clean-room area and/or for removing an object from the clean-room area;
a handling device for moving the object within the clean-room area;
a storage device arranged within the clean-room area, which comprises a plurality of storage locations for receiving a plurality of objects.
1. Production plant, in particular for producing biological-pharmaceutical products, wherein the production plant comprises the following:
a clean room region;
a lock device for feeding an object from an environment of the production plant into the clean room region and/or for removing an object from the clean room region;
a handling device for moving the object within the clean room region;
a storage device arranged within the clean room region, which comprises a plurality of storage locations for receiving a plurality of objects.
Claim Objections
Claims 1-9 are objected to because of the following informalities: The insertion of “A” in front of “production facility” in claim 1, so it reads as follows: “A production facility…”. The subsequent claims, 2-9, should read as follows after the amendment of claim 1: “The production facility according to claim…”. Appropriate correction is required.
Claims 2-9 are objected to because of the following informalities: “Claim” does not need to be capitalized, i.e. “claim”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do the word “means,” and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “means” in claims 4, 6-9; the limitation(s) “transport units” in claims 6-7; the limitations “tool units” in claim 7; “disposal units” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is 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. the claim limitation "storage locations" is not adequately described by the claim nor is it defined in the specification of the instant application.
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 6-9 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 7, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “in particular” in claims 6-9 is a relative term which renders the claim indefinite. The term “in particular” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The previously mentioned term is not defined by the claim nor is it defined by the specification of the instant application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0067781 A1-Osborne (hereinafter “Osborne”).
Regarding claim 1, Osborne discloses production facility, in particular for producing biological-pharmaceutical products (an automated work station for the secure preparation of a final product for medical or pharmaceutical use of a determined composition and/or in determined quantities, para. [0001]), wherein the production facility comprises the following: - a clean-room area (the workstation conforms to the ISO 14644 (clean room standard), para. [0051], lines 1-2; a pharmacy room of a hospital, para. [0066], lines 2-3; isolated chamber 16, para. [0067], line 2);
- a lock device for feeding an object from an environment of the production facility into the clean-room area and/or for removing an object from the clean-room area (a lock device for introducing the vessels and containers into the loading area, para. [0013], lines 1-2; a lock device for unloading the final products from the workstation, para. [0017], lines 1-2; the loading area 18 is designed to form a lock device, for the introduction of the elements and components present in the loading area, para. [0068], lines 1-3);
- a handling device for moving the object within the clean-room area (at least one robot or one programmable logic controller for handling the objects contained in the storage area and/or in the preparation area, para. [0018]; the workstation comprises at least two robots (R1, R2), or programmable logic controllers for handling objects, para. [0020], lines 1-3);
- a storage device arranged within the clean-room area (storage area 20 disposed in workstation 10—where workstation 10 represents a pharmacy room of a hospital, para. [0067], lines 1-4, Fig. 1), which comprises a plurality of storage locations for receiving a plurality of objects (storage area 20 comprises groups 28 of shelves, para. [0071], line 2, Fig. 1; storage 20 is in particular the one containing all the vessels, para. [0082], lines 1-2; storage area 20 also stores syringes of different sizes, needle-less adaptors or pins for vials, flexible bags, etc., para. [0083], lines 1-6).
Regarding claim 2, Osborne discloses wherein the production facility comprises a tool system and a supply device for supplying the tool system with consumable materials (the loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20 and/or, when the layout permits, directly into the preparation area 22, para. [0081], lines 1-4).
Regarding claim 3, Osborne discloses the supply device for storing consumable materials comprises or uses one or more storage locations of the storage device arranged within the clean-room area (loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20 and/or, when the layout permits, directly into the preparation area 22, para. [0081], lines 1-5).
Regarding claim 4, Osborne discloses wherein the lock device forms a component of the supply device or interacts therewith, consumable materials being able to be introduced into the clean-room area by means of the lock device (loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20 and/or, when the layout permits, directly into the preparation area 22, para. [0081], lines 1-5).
Regarding claim 5, Osborn discloses wherein the storage device forms a component of the supply device or interacts therewith (loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20 and/or, when the layout permits, directly into the preparation area 22, para. [0081], lines 1-5).
Regarding claim 6, Osborne discloses wherein, by means of a storage transport device of the storage device, in particular by means of one or more storage transport units of the storage transport device of the storage device, consumable materials supplied from an environment of the production facility can be supplied to one or more storage locations of the storage device (the storage area 20 is separated from the preparation area 22 in particular by a longitudinal vertical partition 56 in which is provided a rotating vertical carrousel 58 with multiple shelving units making it possible to transfer different elements and components from the loading area 20 to the preparation area 22, para. [0113], lines 1-6).
Regarding claim 7, Osborne discloses wherein, by means of a storage transport device of the storage device, in particular by means of one or more storage transport units of the storage transport device of the storage device (the storage area 20 is separated from the preparation area 22 in particular by a longitudinal vertical partition 56 in which is provided a rotating vertical carrousel 58 with multiple shelving units making it possible to transfer different elements and components from the loading area 20 to the preparation area 22, para. [0113], lines 1-6), consumable materials can be supplied to the tool system, in particular one or more tool units of the tool system, for example for supplying consumables and/or tool consumption means to one or more tool units of the tool system (the loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20 and/or, when the layout permits, directly into the preparation area 22, para. [0081], lines 1-4).
Regarding claim 8, Osborne discloses wherein the supply device comprises one or more disposal units by means of which in particular used, consumed and/or contaminated consumables and/or tool consumption means can be removed from the clean-room area (the preparation area 20 comprises an area 32 for securely treating and disposing of the waste issued from the final product preparation method as a whole, para. [0076], lines 1-3; the loading area 18, with its lock device function for introduction into the storage area 20, is used to introduce all the elements, components and consumables (disposables) into the storage area 20 and/or, when the layout permits, directly into the preparation area 22, para. [0081], lines 1-5).
Regarding claim 9, Osborne discloses wherein the supply device comprises a refilling device arranged within the clean-room area, by means of which a consumable, in particular present in liquid form, can be supplied to one or more storage devices of one or more workpiece carriers and/or one or more storage locations (the preparation area 22 is the one in which the final product preparation phase is implemented, in particular by mixing liquid products inside the vials, by weighing them, by transferring the liquid from a vial to a final container Such as an intravenous flexible IV bag or a syringe. It is also where adding diluents and decontaminating is carried out, para. [0086], lines 1-6; liquid pumping means 76, para. [0122], line 2).
Therefore, the reference of Osborne meet the limitations of claims 1-9.
Pertinent Prior Art
Applications 18/414,400, 18/414,584, and 18/414,587 correspond to the following Publication numbers: US20240190651A1, US20240150701A, and US20240158119A1, respectively, also cited in the double patenting rejection noted above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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