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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to an ocular fluid collection device, and Species F, embodiment drawn to Figures 6A-6B, in the reply filed on 10/28/25 is acknowledged.
Claims 28, 29, and 32-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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:
“a compression mechanism“ in claim 1;
“a mechanism“ in claim 1;
“a mechanism“ in claim 5; and
“a compression mechanism“ in claim 6.
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 Objections
Claim 5 is objected to because of the following informalities: the positive recitation of “a mechanism” should apparently read “the mechanism” as it finds antecedent “to prevent retrograde flow of ocular fluid” in claim 1. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the positive recitation of “a compression mechanism” should apparently read “the compression mechanism” as it finds antecedent in claim 1. Appropriate correction is required.
Applicant is advised that should claim 14 be found allowable, claim 25 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
For claims 14 and 15, the claims are objected to because they include reference characters which are not enclosed within parentheses. Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 24 is 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 24 depends from canceled claim 23, rendering the scope of the claim indefinite. For the purposes of examination on the merits and in the interest of compact prosecution, claim 24 is being treated as depending from independent claim 15.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 6, 8, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyman et al. (US 2010/0047914 A1, hereinafter Peyman).
For claim 1, Peyman discloses a device for ocular fluid collection (Fig 3A), the device comprising inter alia:
a housing (syringe barrel) (Fig 3) ([0012-0038]) comprising a handle (right barrel portion) and a hub (left barrel portion) (Fig 3) ([0012-0038]);
a first needle (needle) (Fig 3) ([0012-0038]) having a gauge of 27, 28, 29, 30, 31, 32, 33, or 34 ([0012-0038]);
a collection chamber (syringe interior) (Fig 3) ([0012-0038]) having a proximal and distal end disposed within the housing and coupled at the proximal end to a distal end of the needle (Fig 3) ([0012-0038]); and
a vacuum system (plunger) (Fig 3) ([0012-0038]) within the housing configured to pull the ocular fluid through the needle and into the collection chamber (Fig 3) ([0012-0038]), the vacuum system comprising:
a vacuum chamber (right side of plunger); and
a compression mechanism (right plunger pushing face) connected to the vacuum chamber (Fig 3) ([0012-0038]); and
a mechanism (valve) (Fig 3) ([0012-0038]) to prevent retrograde flow of ocular fluid (Fig 3) ([0012-0038]).
For claim 3, Peyman discloses the device of claim 1, further comprising a self-sealing pierceable vacuum septum (left plunger sealing face) between the collection chamber and the vacuum chamber (Fig 3) ([0012-0038]).
For claim 5, Peyman discloses the device of claim 1, further comprising the mechanism (valve) (Fig 3) ([0012-0038]) to prevent retrograde flow of ocular fluid comprising a pinch valve, a microfluidic valve, a ball check valve, a diaphragm check valve, a swing check valve, a flapper valve, a stop-check valve, a lift-check valve, an in-line check valve, a duckbill valve, a pneumatic non-return valve, a Tesla check valve, or combinations thereof (Fig 3) ([0012-0038]).
For claim 6, Peyman discloses the device of claim 3, wherein the vacuum system further comprises: a vacuum conduit (slide) (Fig 3) ([0012-0038]) positioned at the distal end of the collection chamber (Fig 3) ([0012-0038]); and the compression mechanism configured to push or pull the vacuum chamber towards or away from the vacuum conduit (Fig 3) ([0012-0038]).
For claim 8, Peyman discloses the device of claim 1, wherein the distal end of the collection chamber comprises a fluid separation membrane (plunger stopper) (Fig 3) ([0012-0038]) configured to prevent collected fluid from exiting the collection chamber or contacting the vacuum chamber (Fig 3) ([0012-0038]).
For claim 13, Peyman discloses the device of claim 1, further comprising a dolphin nose tip (left front of syringe barrel) coupled to the housing (Fig 3) ([0012-0038]).
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.
Claim(s) 4, 14, 15, 16, 22, 24, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Feinsod et al. (US 2018/0271701 A1, hereinafter Feinsod).
For claims 14 and 15, Peyman discloses a device for ocular fluid collection, the device comprising inter alia:
a housing (syringe barrel) (Fig 3) ([0012-0038]) comprising a handle (right barrel portion) and a hub (left barrel portion) (Fig 3) ([0012-0038]);
a needle (needle) (Fig 3) ([0012-0038]) having a proximal and distal end Fig 3) ([0012-0038]) and comprising: a gauge of 27, 28, 29, 30, 31, 32, 33, or 34 Fig 3) ([0012-0038]);
a collection chamber (syringe interior) (Fig 3) ([0012-0038]) within the housing and coupled to the distal end of the needle (Fig 3) ([0012-0038]); and
a vacuum system (plunger) (Fig 3) ([0012-0038]) within the housing configured to pull the ocular fluid through the needle and into the collection chamber (Fig 3) ([0012-0038]).
For claims 14 and 15, Peyman discloses the claimed invention as set forth above, except for explicitly disclosing: the needle comprising the proximal end comprising a three bevel geometry having a primary bevel surface having a primary bevel angle (Ap) between about 50 and about 100 with respect to a longitudinal axis of the needle, a secondary bevel surface having an angle (As) between about 90 and about 180 with respect to a longitudinal axis of the needle, and a tertiary bevel surface having an angle (As) between about 90 and about 180 with respect to a longitudinal axis of the needle, the secondary bevel surface and the tertiary bevel surface having a tertiary bevel angle (At) between about 150 and about 30° with respect to a transverse axis of the needle, a primary bevel length (L3) between about 0.90 mm and about 1.30 mm, and a lumen length (L2) between about 0.5 mm and 0.9 mm;
For claims 14 and 15, however, Feinsod in the same field of ocular syringe aspiration endeavor, teaches a syringe needle (11) comprising a plurality lengths with a plurality of bevels and angles specifically configured for piercing a cornea ([0018, 0051, 0053, 0063]).
Thus for claims 14 and 15, although Peyman in view of Feinsold is not explicit with respect to the claimed bevel angles and lengths, at the time of the invention it would have been obvious to one having ordinary skill in the art to configure the needle with the proximal end comprising a three bevel geometry having a primary bevel surface having a primary bevel angle (Ap) between about 50 and about 100 with respect to a longitudinal axis of the needle, a secondary bevel surface having an angle (As) between about 90 and about 180 with respect to a longitudinal axis of the needle, and a tertiary bevel surface having an angle (As) between about 90 and about 180 with respect to a longitudinal axis of the needle, the secondary bevel surface and the tertiary bevel surface having a tertiary bevel angle (At) between about 150 and about 30° with respect to a transverse axis of the needle, a primary bevel length (L3) between about 0.90 mm and about 1.30 mm, and a lumen length (L2) between about 0.5 mm and 0.9 mm. Given the finite number of identified, predictable solutions (angles and lengths), and with a reasonable expectation of success (piercing cornea for aspiration), it would have been obvious to one of ordinary skill in the art to try adjusting the bevel angle(s) and length(s) for insertion of the needle into the cornea while “minimizing the risk of contacting other intraocular structures” (Feinsold [0074]) and while enabling aspiration of ocular fluid with the syringe.
For claims 4 and 16, Peyman in view of Feinsold discloses the claimed invention as set forth above, except for explicitly disclosing wherein the needle comprises an internal portion between about 14 mm and about 26 mm in length disposed inside the housing and an external portion between about 4 mm and about 6 mm in length disposed outside the housing.
For claims 4 and 16, although Peyman in view of Feinsold is not explicit with respect to the needle lengths disposed inside and outside the housing, at the time of the invention it would have been obvious to one having ordinary skill in the art to configure the needle with an internal portion between about 14 mm and about 26 mm in length disposed inside the housing and an external portion between about 4 mm and about 6 mm in length disposed outside the housing. Given the finite number of identified, predictable solutions (needle length and stiffness), and with a reasonable expectation of success (piercing cornea for aspiration), it would have been obvious to one of ordinary skill in the art to try adjusting the relative ratios amongst interior and exterior needle lengths for insertion of the needle into the cornea to “facilitate penetration of the outer layer of the eye, namely just the cornea, just slightly entering the anterior chamber, minimizing the risk of contacting other intraocular structures” (Feinsold [0051]) and while enabling aspiration of ocular fluid with the syringe.
For claim 22, Peyman in view of Feinsod discloses the device of claim 15, wherein Peyman discloses the device further comprises a dolphin nose tip (left front of syringe barrel) coupled to the housing (Fig 3) ([0012-0038]).
For claim 24, Peyman in view of Feinsod discloses the device of claim 23, wherein Peyman discloses the device further comprises a valve (valve) (Fig 3) ([0012-0038]) configured to prevent retrograde flow of the ocular fluid comprising a pinch valve, ball check valve, a diaphragm check valve, a swing check valve, a flapper valve, a stop- check valve, a lift-check valve, an in-line check valve, a duckbill valve, a pneumatic non- return valve, a Tesla check valve, or combinations thereof (Fig 3) ([0012-0038]).
For claim 25, Peyman in view of Feinsod an discloses the device of claim 15, wherein Peyman discloses the vacuum system comprises a vacuum chamber (right side of plunger), a decompression handle (right plunger pushing face), a vacuum conduit (slide), vacuum septum (plunger stopper), or combinations thereof (Fig 3) ([0012-0038]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for collecting ocular fluid.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791