DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6 April 2026 has been entered.
Drawings
The drawings were received on 20 February. These drawings are unacceptable as they contain new matter. The specification and drawings as originally filed to not support that the removal station 413 includes an “upper surface 409” as there is no original indication that the top of the removal station 413 is in the form of a “surface.” Further, there is no original basis for an upper surface which is “operative to interact with the sheath 503 as a heating surface.” Therefore, new corrected drawings must be supplied with the numeral removed.
Specification
The amendment filed 6 April 2026 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: the entirety of the amendments. It is noted that there is no exception to allow for the introduction of “prior art” into a specification of an application. Any subject matter which was not described in the application as filed can be considered to be new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Interpretation
The preamble of claims 1, 5 and 14 are not viewed to be further limiting. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997).
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.
The limitations of “means for heating the sheath” in claims 4, 12, and 20 are viewed to invoke §112(f).
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless 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: “a remotely operated manipulation system for protection and/or unprotection of the fluid path“ in claims 1 and 5; and “a removal station” in claims 1, 5 and 20.
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.
Claims 1-20 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 regard to claims 1, 5 and 14, as the claim limitation “a removal station” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, and the specification and drawings have been amended with new matter that would change the interpretation of the claim limitation, claims 1, 5 and 14 have been rejected as failing the written description requirement in accordance with MPEP § 2163.06(I). The MPEP states “[i]n an instance in which the claims have not been amended, per se, but the specification has been amended to add new matter, a rejection of the claims under 35 U.S.C. 112, first paragraph should be made whenever any of the claim limitations are affected by the added material.”
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 1-20 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 regard to claims 1, 5 and 14, claim limitation “a removal station” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The Specification does not describe the removal station’s structure as stated in the Patent Board Decision mailed 18 September 2025. The decision states that the “Specification identifies a variety of ways in which the sheath can be removed, but none of these descriptions identified removal station structure sufficient to perform the entirety of the removal station’s function.” Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The amended specification received 6 April 2026 includes new matter as stated above and is thus viewed to also fail the written description requirement.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
10. Claim limitation “means for heating a sheath” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not describe the removal station’s structure in any detail as noted in the Patent Board Decision mailed 18 September 2025. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-11 and 13-19 are rejected under pre-AIA 35 U.S.C. 102(a,e) as being anticipated by Ronsick et al. (US 2010/0288060; hereinafter “Ronsick”).
In regard to claims 1-3, Ronsick discloses an apparatus comprising a remotely operated manipulation system comprising a robotic arm manipulation system (robotic transfer mechanism 1910) capable of protecting and/or unprotecting a fluid path (robotic transfer mechanism 1910 can cooperate with a station for automatically removing and replacing the sheath of the needle 3202), and a removal station (see [0211]) that includes a surface operative to interact with part of the sheath. The manipulation system further includes a robot end tool which includes at least one surface that is shaped to hold the end piece as described in [0107] with the disclosure of “robot gripping and handling mechanisms.” See Figures 2, 15, 27, 31-34, and 43A and paragraphs [0054], [0106], [0107], [0110], [0111], [0153], [0211], [0241]-[0242] and [0255].
In regard to claims 5-7, the above rejection of claims 1-3 are applied in the same manner for the identical limitations. Ronsick discloses a controlled environment enclosure (insulated incubation enclosure 1812) which is capable of operating with a fluid path as recited. See Figure 27 and [0229]. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP § 2114).
In regard to claims 8-11, Ronsick discloses wherein the fluid path includes a peristaltic pump (rolling diaphragm pump 1710) and a fluid container (syringe body 3200) which are capable of being received within the enclosure (insulated incubation enclosure 1812). See Figures 31-36 and paragraphs [0241] and [0245].
In regard to claim 13, Ronsick discloses a controller (robot controller PC 4906) for communicating control instructions to the robotic arm manipulation system (robot 1910). See Figure 50 and [0293]-[0295].
In regard to claims 14 and 15, Ronsick discloses an apparatus comprising a remotely operated manipulation system comprising a robotic arm manipulation system (robotic transfer mechanism 1910) capable of positioning a fluid path (robotic transfer mechanism 1910 can cooperate with a station for automatically removing and replacing the sheath of the needle 3202) which is capable of filling pharmaceutical containers, and a removal station (see [0211]) that includes a surface operative to interact with part of the sheath. The manipulation system further includes a robot end tool which includes at least one surface that is shaped to hold the end piece as described in [0107] with the disclosure of “robot gripping and handling mechanisms.” Ronsick discloses a controller (robot controller PC 4906) for communicating control instructions to the robotic arm manipulation system (robot 1910) which would also enable the fluid path to fill pharmaceutical containers. Ronsick discloses a controlled environment enclosure (insulated incubation enclosure 1812) which is capable of operating with the fluid path. See Figures 2, 15, 27, 31-34, 43A, and 50 and paragraphs [0054], [0106], [0107], [0110], [0111], [0153], [0211], [0229], [0241]-[0242], [0255], and [0293]-[0295]. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP § 2114).
In regard to claims 16-19, Ronsick discloses wherein the fluid path includes a peristaltic pump (rolling diaphragm pump 1710) and a fluid container (syringe body 3200) which are capable of being received within the enclosure (insulated incubation enclosure 1812). See Figures 31-36 and paragraphs [0241] and [0245].
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 4, 12 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ronsick.
In regard to claim 4, 12 and 20, Ronsick is silent in regard to the removal station including means for heating the sheath. The Examiner takes Official Notice that it is well understood in the art that selective heating can be used to loosen friction fittings. For example, heating is widely used to loosen tight lids and bolts. Therefore, it would have been within the ambit of one of ordinary skill in the art at the time of the invention to have used heating means in the removal station to loosen the sheath on the needle of the apparatus of Ronsick without creating any new or unexpected results. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Response to Arguments
Applicant's arguments filed 6 April 2026 have been fully considered but they are not persuasive.
Applicant argues that “the preamble of the noted Claims recite structural items that serve to define the recited elements of the Claims are requests (sic) that the preamble be considered in that context.” The Examiner respectfully disagrees. The Applicant has not provided any rationale as to why the preamble should be considered beyond the mere conclusion that the preamble recites “structural items.” The Examiner has correctly interpreted the preamble as being non-limiting as the body of the claim fully and intrinsically sets forth all the limitations of the claimed invention. If Applicant desires a “structural item” recited in the preamble to be further limiting, the “structural item” should be amended into the body of the claim.
Applicant argues that the specification has been amended “without adding new matter” as the amendments “add the text regarding prior art systems and how in light of the knowledge of one of ordinary skill would interpret the original specification.” The Examiner has fully considered the argument but has not found it to be persuasive. As the amendments add subject matter which was not present in the application as filed, the amendments are considered to be new matter. There is simply no exception to allow for “prior art” to be amended into a patent application without the amendment being considered new matter, nor is there any reason to believe that the subject matter is “common general knowledge in this field” or having “predictable mechanical interactions.”
Applicant argues that the “courts have long recognized that amendments clarifying how a disclosed mechanical structure operations or what it inherently includes do not add new matter.” The Examiner has fully considered the argument but has not found it to be persuasive. The amendments to the specification go beyond “clarifying” as simply no mechanical structure was originally disclosed. Therefore, the amendments clearly constitute new matter as the amendments regard structural arrangements wherein the specification as originally presented only contained a description of the intended function of the component.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY C CLEVELAND whose telephone number is (571)270-5041. The examiner can normally be reached M-F 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY C CLEVELAND/Primary Examiner, Art Unit 1774
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