DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of Group I and Species W (Figures 24A-B) in the reply filed on 10/7/2025 is acknowledged. The traversal is on the ground(s) that. This is not found persuasive because Inventions I-III are not drawn to distinct inventions because they each require the suction device of Claim 54.
While Applicant is correct that Claim 54 is generic to each of Inventions I-III, the examiner maintains that each of these inventions are drawn to distinct subject matter that does not overlap in scope. As discussed in the Restriction Requirement, Invention I is drawn to a kit, Invention II is drawn to a method of using a suction device, and Invention III is drawn to a fluid communication assembly.
The requirement is still deemed proper and is therefore made FINAL.
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 applications, Application Nos. 13/381,885, 14/267,636, 15/198,690, 15/256,349, 15/681,165, and 16/547,273, 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 for the following reasons:
None of the claim language in claims 54-58 is supported in the specification. The claim language of instant claims 54-58 and 65-69 has been copied verbatim from US Patent 11,013,839, which is by different inventors and a different assignee.
The following claimed subject matter at the end of claims 54 and 65 is not supported in the instant specification or figures:
“wherein said connection portion comprises a duct wall at least partially defining a connection duct from said inlet to said outlet, said connection portion comprising a partition wall extending at least partially from said duct wall, wherein said fluid inlet extends in a circumferential direction, said fluid inlet further extending in an axial direction being substantially perpendicular to said circumferential direction, wherein said partition wall does not extend in the circumferential direction.”
Figures 24A-B do not show any structural specifics of a partition portion or partition portion extension, and therefore provide no support for a partition wall extending at least partially from said duct wall, wherein said fluid inlet extends in a circumferential direction, said fluid inlet further extending in an axial direction being substantially perpendicular to said circumferential direction, wherein saif partition wall does not extend in the circumferential direction.
Since independent claims 54 and 65 require limitations that are not supported in the specification or figures, Claims 54-58 and 65-69 are not entitled to the benefit of the prior applications
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
None of the language used or structural elements required in instant claims 54-58 and 65-69 are supported in the instant specification.
The examiner notes that claims 54-58 and 65-69 are identical to claims 1, 2, and 4-6 of US Patent No. 11,013,839 to Anderson. Without the benefit of Anderson’s specification, it would be impossible to ascertain what is being claimed in instant claims 54-58 and 65-69.
The examiner recommends rewriting the claims using language supported in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following elements must be shown or the feature(s) canceled from the claim(s):
A suction device comprising an attachment portion adapted to be attached to a wound cover member, said suction device comprising a fluid inlet being at least partially circumscribed by said attachment portion, said suction device also comprising a fluid outlet, said suction device further comprising a connection portion adapted to, at least during one operation condition of said suction device, provide a fluid communication between said fluid inlet and said fluid outlet, wherein said connection portion comprises a duct wall at least partially defining a connection duct from said inlet to said outlet, said connection portion comprising a partition wall extending at least partially from said duct wall, wherein said fluid inlet extends in a circumferential direction, said fluid inlet further extending in an axial direction being substantially perpendicular to said circumferential direction, wherein said partition wall does not extend in the circumferential direction.
A fluid outlet extends in a longitudinal direction (L), said partition wall extending in a partition wallextension (EPw) that is substantially parallel to said longitudinal direction (L).
A wound cover member comprising a film.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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 54-58 and 65-69 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.
Claims 54-58 and 65-69 fail to comply with the written description requirement for the following reasons:
None of the claim language in claims 54-58 is supported in the specification. The claim language of instant claims 54-58 and 65-69 has been copied verbatim from claims 1, 2, and 4-6 of US Patent 11,013,839, which is by different inventors and a different assignee. Without the benefit of Anderson’s specification, it would be impossible to ascertain what is being claimed in instant claims 54-58 and 65-69.
The following claimed subject matter at the end of claims 54 and 65 is not supported in the instant specification or figures:
“wherein said connection portion comprises a duct wall at least partially defining a connection duct from said inlet to said outlet, said connection portion comprising a partition wall extending at least partially from said duct wall, wherein said fluid inlet extends in a circumferential direction, said fluid inlet further extending in an axial direction being substantially perpendicular to said circumferential direction, wherein said partition wall does not extend in the circumferential direction.”
Figures 24A-B do not show any structural specifics of a partition portion or partition portion extension, and therefore provide no support for a partition wall extending at least partially from said duct wall, wherein said fluid inlet extends in a circumferential direction, said fluid inlet further extending in an axial direction being substantially perpendicular to said circumferential direction, wherein saif partition wall does not extend in the circumferential direction.
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 58 and 69 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.
Claim limitation “fluid communication means” in Claims 58 and 69 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 is devoid of the phrase “fluid communication means” and does not clearly disclose a structure associated with the claimed 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.
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
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 54-58 and 65-69 are rejected under pre-AIA 35 U.S.C. 102(a) as being clearly anticipated by Anderson (US 11,013,839).
See Figures 1-6.
The examiner notes that instant claims 54-58 are identical to claims 1, 2, and 4-6 of Anderson.
Instant claims 65-69 differ from claims 1, 2, and 4-6 of Anderson only in that independent claim 65 omits the phrase “wherein said partition wall does not extend in the circumferential direction.”
Claims 54-58 and 65-69 are rejected under pre-AIA 35 U.S.C. 102(b) as being clearly anticipated by Anderson (2018/0280596; hereinafter “Anderson 2018”).
See Figures 1-6. The examiner notes that all subject matter of instant claims 54-58 is disclosed in claims 1 and 8-13 of Anderson 2018.
Claims 54-56, 58, 65-67, and 69 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Vess et al. (US 2010/0305524).
With respect to Claims 54 and 65, Vess teaches a suction device 212 (Figure 3B) comprising:
an attachment portion (see annotated figure below; labeled as a flange 34 in similar figure 1; [0037]) adapted to be attached to a wound cover member 122,
said suction device comprising a fluid inlet (see annotated figure) being at least partially circumscribed by said attachment portion (the attachment portion is generally flange shaped and therefore circumscribes the inlet [0037]),
said suction device also comprising a fluid outlet (Figure 3B; see annotated figure below),
said suction device further comprising a connection portion 230 adapted to, at least during one operation condition of said suction device, provide a fluid communication between said fluid inlet and said fluid outlet (paragraph [0048]),
wherein said connection portion comprises a duct wall at least partially defining a connection duct from said inlet to said outlet (Figure 3B; see annotated figure below),
said connection portion comprising a partition wall extending at least partially from said duct wall (Figure 3B; see annotated figure below),
wherein said fluid inlet extends in a circumferential direction (this limitation has been interpreted to mean that the inlet extends circumferentially around the central axis of the fluid inlet and attachment portion) , said fluid inlet further extending in an axial direction being substantially perpendicular to said circumferential direction, wherein said partition wall does not extend in the circumferential direction (Figure 3B; see annotated figure below).
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Annotated Figure 3B of Vess
With respect to Claims 55 and 66, Vess teaches that the fluid outlet extends in a longitudinal direction (L), said partition wall extending in a partition wall extension (EPW) that is substantially parallel to said longitudinal direction (L). See the annotated figure below.
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Annotated Figure 3B of Vess
With respect to Claims 56 and 67, Vess teaches a kit for a negative pressure wound therapy system (Figures 1 and 3B), the kit comprising:
a suction device 212 according to one of claims 54 and 65 (Figure 3B; see the rejection of Claims 56 and 67 above); and
a wound cover member 222 adapted to be attached over a wound (Figure 3B; paragraph [0048]).
With respect to Claims 58 and 69, Vess teaches that the kit further comprises a fluid communication means (tube 236; Figure 3B; paragraph [0048]) adapted to provide a fluid communication between said fluid outlet and a negative pressure source (36, 38, 40; Figure 1. See paragraphs [0007], [0031], [0037-0038], [0047-0048], especially [0048].
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 57 and 68 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Vess.
With respect to Claims 57 and 68, Vess teaches the suction device and kit of claims 56, 58, 65, and 67, and further teaches the wound cover that covers the wound. In the description of Figure 1, Vess further teaches that the wound cover may comprise a polymeric or elastomeric wound cover film (paragraphs [0005], [0032], and [0034]), and it is abundantly clear that this disclosure applies to the wound cover in all embodiments, including wound cover 222 in Figure 3B.
However, in the event that applicant does not clearly envisage this interpretation, it would have been obvious to one of ordinary skill in the art at the time of invention to modify Vess’s embodiment of Figure 3B such that the wound cover 222 comprises a polymeric or elastomeric wound cover film, as suggested by Vess, in order to provide a well-known means for forming a substantially fluid-tight seal with the surrounding skin [0034].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eckstein (US 8,771,224) teaches an attachment device for NPWT having a plurality of parallel channels separated by one or more partition walls (Figures 5a-5b).
Adie (US 9,061,095) and Heagle (US 2010/0185163) each teach a NPWT device comprising a connector with an inlet and outlet at 90 degree angle (Figure 1b of Adie; Figures 1A-1C of Heagle).
Lockwood (US 2005/0004534) teaches a vented NPWT device having parallel suction and air leak channels (Figures 1-3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781