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 .
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 07/26/2023 and 01/19/2024, have been considered by the examiner.
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: The originally filed specification fails to provide proper antecedent basis for the claimed “fluid conduit” or “contamination prevention member” recited in independent claim 1. Specifically, the specification does not provide disclosure for “a fluid conduit coupled to a second end of the needle” or “a contamination prevention member adjacent to the container and at least partially defining an interior space that is at least substantially free of contamination during at least a portion of the pre-delivery state.”
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 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: “delivery member” in claim 1; “contamination prevention member” in claim 1; and “insertion mechanism” in claim 9.
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 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 1-12 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 1] The claim recites the limitation of “an interior space that is at least substantially free of contamination” in the 9th and 10th lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since the term “substantially” is a relative term which renders the claim indefinite. The term “substantially” 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. As such, the degree of “contamination” permissible by the claim is rendered indefinite. For purposes of examination, the phrase has been read out of the claim.
[Claim 1] Claim limitation “contamination prevention member” 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 written description fails to disclose a clear linkage/association for which structure(s) is/are responsible for performing the recited of functionality of “at least partially defining an interior space that is at least substantially free of contamination during at least a portion of the pre-delivery state.” 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 5] The claim recites the limitation of “a housing removable attachable to skin of the patient.” The examiner is unable to determine the metes and bounds of the claim, as the phrasing is grammatically incorrect. For purposes of examination, it is interpreted that the limitation should recite “a housing removably attachable to skin of the patient.”
[Claims 2-12] The claims are rejected based upon their dependency from independent clam 1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6, which depends directly from claim 5, recites the identical claim limitations of claim 5 (see 112b interpretation above). As such, claim 6 is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-8, 10, and 12, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kriesel et al. (USPN 5,330,426).
[Claims 1 and 10] Kriesel teaches a drug delivery device (figure 10) comprising:
a container (figure 5, items 30/distal portion of item 36) including a wall (figure 5, item 32) and a septum (figure 5, distal portion of item 36; see annotated figure below), wherein an inner surface of the wall (figure 5, item 32) and a proximal surface (see annotated figure below) of the septum (figure 5, distal portion of item 36) at least partially define a reservoir (figure 5, item 38) filled or fillable with a drug (figure 5, item 27);
a stopper (figure 5, proximal portion of item 36; see annotated figure below) movably disposed within the container (figure 5, items 30/distal portion of item 36) (column 6, lines 67-68; column 7, line 1);
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a needle (figure 5, item 47) having a pre-delivery state (figures 5 and 7) wherein a first end (proximal portion of item 47) of the needle (figure 5, item 47) is adjacent to the container (figure 5, items 30/distal portion of item 36) and a delivery state (figure 10) wherein the first end (proximal portion of item 47) of the needle (figure 5, item 47) is disposed through the proximal surface of the septum (figure 5, distal portion of item 36) into the reservoir (figure 5, item 38) of the container (figure 5, items 30/distal portion of item 36);
a fluid conduit (figure 10, items 28/52) coupled to a second end (distal portion of item 47) of the needle (figure 5, item 47);
a delivery member (figure 10, item 22) configured to be inserted into a patient and coupled in fluid communication with the reservoir (figure 5, item 38) of the container (figure 5, items 30/distal portion of item 36) via at least the fluid conduit (figure 10, items 28/52);
a contamination prevention member (figure 5, item 40) adjacent to the container (figure 5, items 30/distal portion of item 36) and at least partially defining an interior space (interior space on either side of item 42) that is at least substantially free of contamination (see 112b interpretation above) during at least a portion of the pre-delivery state (figures 5 and 7) (column 7, lines 1-4); and
wherein, prior to (figures 5 and 7) the delivery state (figure 10), the first end (proximal portion of item 47) of the needle (figure 5, item 47) is disposed at least temporarily within the interior space (interior space on either side of item 42) of the contamination prevention member (figure 5, item 40) (figures 5 and 7).
[Claim 2] Kriesel teaches the limitations of claim 1, upon which claim 2 depends. In addition, Kriesel discloses a distal surface (figure 5, item 36a) of the septum (figure 5, distal portion of item 36) and a proximal surface of the contamination prevention member (figure 5, item 40) are spaced by a distance in at least the pre-delivery state (figures 5 and 7).
[Claim 3] Kriesel teaches the limitations of claim 1, upon which claim 3 depends. Kriesel also discloses the interior space (interior space on either side of item 42) of the contamination prevention member (figure 5, item 40) is sterile during the at least a portion of the pre-delivery state (figures 5 and 7) (column 7, lines 1-4).
[Claim 4] Kriesel teaches the limitations of claim 1, upon which claim 4 depends. Kriesel further discloses wherein, in at least the delivery state (figure 10), at least a portion (figure 5, item 36a) of the septum (figure 5, distal portion of item 36) is disposed within the interior space (interior space on either side of item 42) of the contamination prevention member (figure 5, item 40).
[Claims 5 and 6] Kriesel teaches the limitations of claim 1, upon which claims 5 and 6 depend. Kriesel also teaches a housing (figure 10, item 12) removably attachable to skin of the patient (see 112b interpretation above) (The examiner notes the structure taught by Kriesel is functionally capable of being “removably attachable to skin of the patient.”)
[Claims 7 and 8] Kriesel teaches the limitations of claim 6, upon which claims 7 and 8 depend. In addition, Kriesel discloses the needle (figure 5, item 47) and the fluid conduit (figure 10, items 28/52) are disposed at least partially within the housing (figure 10, item 12) (figure 10).
[Claim 12] Kriesel teaches the limitations of claim 1, upon which claim 12 depends. Kriesel also teaches the delivery member (figure 10, item 22) comprises a cannula (column 6, lines 50-56).
Claim Rejections - 35 USC § 103
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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kriesel et al. (USPN 5,330,426), in view of Tenczar (USPN 4,022,205).
[Claim 11] Kriesel teaches the limitations of claim 1, upon which claim 11 depends. Kriesel does not specifically disclose the fluid conduit comprises at least one flexible tube.
However, Tenczar teaches a delivery device (figure 1, items 10/36) comprising a container (figure 1, item 10), a needle (figure 1, item 30), a contamination prevention member (figure 1, item 16), and a fluid conduit (figure 4, item 44) coupled with an end of the needle (figure 1, item 30); wherein the fluid conduit (figure 4, item 44) comprises at least one flexible tube (column 3, line 68; column 4, lines 1-2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the fluid conduit taught by Kriesel, with the use of a flexible tube, as taught by Tenczar, in order to provide increased functionality and control, by allowing for a means by which therapeutic fluid might be easily redirected from a point of origin to a treatment site on a patient.
Allowable Subject Matter
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 prior art of record fails to disclose or render obvious the structure recited in dependent claim 9.
The closest prior art of record is Kriesel et al. (USPN 5,330,426) and Tenczar (USPN 4,022,205).
The prior art of record fails to teach among all the limitations or render obvious a structure comprising a drug delivery device comprising:
a container including a wall and a septum, wherein an inner surface of the wall and a proximal surface of the septum at least partially define a reservoir filled or fillable with a drug;
a needle having a pre-delivery state wherein a first end of the needle is adjacent to the container and a delivery state wherein the first end of the needle is disposed through the proximal surface of the septum into the reservoir of the container;
a fluid conduit coupled to a second end of the needle;
a delivery member configured to be inserted into a patient and coupled in fluid communication with the reservoir of the container via at least the fluid conduit;
a contamination prevention member adjacent to the container and at least partially defining an interior space that is at least substantially free of contamination during at least a portion of the pre-delivery state; and
wherein, prior to the delivery state, the first end of the needle is disposed at least temporarily within the interior space of the contamination prevention member.
Specifically, regarding dependent claim 9, the prior art to Kriesel and Tenczar, either alone or in combination, fails to disclose or render obvious the specific structural and/or functional features as claimed;
wherein the device further comprises:
an insertion mechanism configured to move at least a portion of the delivery member through an opening in a wall of the housing for insertion into the skin of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 01/15/2026