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 .
Drawings
Figure1a, 1b, 1c should be designated by a legend such as --Prior Art-- because only that which is old is illustrated as detailed in instant application specification as-filed page 7 line 1-page 9 line 15 specifically see page 7 lines 1-6, page 8 lines 4-5. See MPEP § 608.02(g).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because: [a] reference character “3a” has been used to designate both “proximal end 3a” (instant application as-filed page 9 lines 24-25) and “distal end 3a” (instant application as-filed page 10 lines 24-25); [b] reference character “441” has been used to designate both “buttons 441” (instant application as-filed page 17 lines 18) and “a stop face 441” (instant application as-filed page 11 line 31).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Specification
The disclosure is objected to because of the following informalities:
“Le protection device … in page 9 line 18 needs to be corrected. A suggested correction is – [[Le]] The protection device --.
The listing of references in the specification such as in page 17 line 31 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 1 “wherein the body is capable of sliding on the tube in a longitudinal direction … the assembly means of the body and the complementary assembly means of the tube are capable of immobilizing the body in longitudinal translation in the first position and the second position” needs to be corrected. A suggested correction --wherein the body is [[capable of]] configured for sliding on the tube in a longitudinal direction … the assembly means of the body and the complementary assembly means of the tube are [[capable of]] configured for immobilizing the body in longitudinal translation in the first position and the second position-- to avoid potential intended use/functional limitation interpretation as detailed in MPEP 2111.04 which states inter alia that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (See MPEP 2111.04 ).
Each of claims 5-6, 8-9, 12-15, 18 recite “capable of” functional/intended use encompassing limitations which need to be corrected. A suggested correction is replacing “capable of” with –configured for-- to avoid potential intended use/functional limitation interpretation as detailed in MPEP 2111.04 which states inter alia that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (See MPEP 2111.04 ). As an example amend claim 5 “wherein the assembly means of the body and the complementary assembly means of the tube are capable of immobilizing the body irreversibly in longitudinal translation in the second position” to -- wherein the assembly means of the body and the complementary assembly means of the tube are [[capable of]] configured for immobilizing the body irreversibly in longitudinal translation in the second position--. Similar amendments are proposed for claims 6, 8-9, 12-15, 18 as well.
Each of claims 7-8, 11 recite “so as to” encompassing result-oriented/functional limitations which need to be corrected. A suggested correction is replacing “so as to” with –[[so]] in a manner as to-- to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “so as to” is required or not required. As an example amending claim 11 “said catheter comprising a hollow conduit, a distal portion of the conduit extending beyond the distal part of the body so as to be situated outside the protection device” to -- said catheter comprising a hollow conduit, a distal portion of the conduit extending beyond the distal part of the body [[so]] in a manner as to be situated outside the protection device--. Similar amendments are proposed for claims 7-8 as well.
Each of claims 6-8, 11 recite “when” encompassing conditional limitations which need to be corrected. A suggested correction is replacing “when” with –[[when]] while-- to avoid conditional limitation recitation which would raise question as to what occurs when the condition is not met. As an example amending claim 11 “a distal portion of the conduit extending beyond the distal part of the body … as to be situated outside the protection device when the protection device is in the sampling configuration, said distal portion of the conduit being arranged inside the distal part of the body when the protection device is in the protection configuration” to --a distal portion of the conduit extending beyond the distal part of the body …as to be situated outside the protection device [[when]] while the protection device is in the sampling configuration, said distal portion of the conduit being arranged inside the distal part of the body [[when]] while the protection device is in the protection configuration--. Similar amendments are proposed for claims 6-8.
Claim 10 “wherein the body comprises a proximal part communicating with the distal part via an interface opening said proximal part having an internal cross section narrowing towards said interface opening” needs to be corrected. A suggested correction is -- wherein the body comprises a proximal part communicating with the distal part via an interface opening, said proximal part having an internal cross section narrowing towards said interface opening--.
Claim 1 line 1 “A protection device for medical device comprising” needs to be corrected. A suggested correction is -- A protection device for medical device comprising: -- as the all the limitations in claim 1 lines 1-10 apply to claim 1 line 1 preamble.
Claim 11 line 1 “a protection device” needs to be corrected to –[[a]] the protection device—in light of its “A protection device” antecedent in claim 1 line 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1-18 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 in lines 1-2 recites “A protection device for medical device comprising a substantially cylindrical body and a tube” which renders this claim unclear. More specifically, it is unclear as to the limitation “comprises substantially cylindrical body and a tube” qualifies which of preceding structures or combination of structures i.e. protection device, medical device or both protection device and medical device.
Claim 13 line 3 recites “said distal end” which renders this claim unclear. More specifically, it is unclear as to whether claim 13 line 3 “said distal end” is the same as, different than or in addition to “a distal end bore” recited in claim 13 line 2.
Claim 16 recites “sampling said element to be sampled into the transfer device by creating a pressure drop in the transfer device by means of the syringe” which renders this claim unclear. More specifically, it is unclear as to what is meant by “sampling said element to be sampled into the transfer device". Examiner suggests amending to – [[sampling]] transferring said element to be sampled into the transfer device by creating a pressure drop in the transfer device by means of the syringe—or --[[sampling]] suctioning said element to be sampled into the transfer device by creating a pressure drop in the transfer device by means of the syringe--.
Dependent claims 2-18 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-18 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation 35 U.S.C. 112(f)
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:
Claims the term occurs in
Claim term
Corresponding Structures recited in original specification as-filed
1, 5, 6, 8
assembly means
340, 341, 342, slot, , see at least page 10 lines 17-18
1, 5, 6
complementary assembly means
440, 442, see at least page 11 lines 21-29, page 12 lines 4-5 , stud, projection
8
means for guiding in translation and immobilizing in rotation
Groove 342, see at least page 10 lines 26-28
8
complementary means for guiding in translation and immobilizing in rotation
projections 442, see at least page 12 lines 1-10
9, 14
fastening means
a locking screw, resilient clips, see at least page 19 lines 1-5
12
a proximal end assembly means
annular element or annular clip, see at least page 9 lines 16-18
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.
This application also includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means of the medical transfer assembly” in claim 16 in claim 16 “means of the syringe”.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification page 6 lines 26-33, page 17 lines 3-5, page 12 lines 31-33.
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
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 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 of this title, 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.
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.
Claims 1-3, 5, 6, 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dufresne et al. (Pub. No.: US 5817065 A, hereinafter referred to as "Dufresne") as evidenced by Kulstad (Pub. No.: US 20210085520 A1, hereinafter referred to as "Kulstad").
As per independent Claim 1, Dufresne discloses a protection device for medical device (Dufresne in at least fig. 2-4, abstract, col. 2-4, col. 6 lines 9-15 for example discloses relevant subject-matter. More specifically, Dufresne in at least fig. 2-3, abstract, col. 2 lines 4-14 for example discloses protection device 2 for medical device/needle) comprising
a substantially cylindrical body (see at least fig. 2-3, ref. ele. 4) and a tube (see at least fig. 2-3, ref. ele. 16), said body and tube being hollow and open at their ends (see fig. 2-3), wherein the body comprises distal part (see fig. 2-3 near end 10) and assembly means (see at least fig. 2-3, ref. ele. 24), the tube comprises complementary assembly means (see at least fig. 2-3, ref. ele. 18, 26), and further wherein the body is capable of sliding on the tube in a longitudinal direction from a first position corresponding to a sampling configuration of the protection device (see fig. 2) to a second position corresponding to a protection configuration of the protection device (see fig. 3), and the assembly means of the body (see at least fig. 2-3, ref. ele. 24) and the complementary assembly means of the tube (see at least fig. 2-3, ref. ele. 26) are capable of immobilizing the body in longitudinal translation in the first position and the second position (see abstract, fig. 2 vs. fig. 3, col. 3 lines 6-31).
Dufresne does not explicitly state that the body distal part is thermally insulating. However, Dufresne’s disclosure in col. 2 lines 42-45 stating “housing 4 is composed of a material adapted for use in a medical environment, such as moulded medical grade polypropylene or the like” makes obvious subject-matter as now explicitly, positively and specifically recited by the Applicants i.e. wherein the body comprises a thermally insulating distal part as polypropylene is well-known for having thermally insulating properties as evidenced by Kulstad [0027] (see at least Dufresne col. 2 lines 42-45 “housing 4 is composed of a material adapted for use in a medical environment, such as moulded medical grade polypropylene or the like”; Kulstad [0027] “thermally insulating sleeve comprises a material having poor thermal conductivity, such as a plastic… plastic is a thermoplastic, thermoset, or elastomer… sleeve is formed from polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyamides, polyester, polyurethane, or mixtures, co-polymers, and blends thereof.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the body distal part as taught by Dufresne, with the thermally insulated body distal part, as made obvious by Dufresne. A person of ordinary skill would have been motivated to do so in light of Kulstad, with a reasonable expectation of success, for the advantage of conferring thermal insulation to desired portions of device body.
As per dependent Claim 2, the Dufresne as evidenced by Kulstad as a whole further discloses protection device wherein the length of the protection device in the protection configuration is greater than the length of the protection device in the sampling configuration (Dufresne’s disclosure in at least fig. 2-3 wherein the length of the protection device in the protection configuration is different than the length of the protection device in the sampling configuration (see fig. 2 sampling/extended configuration and fig. 3 protection/retracted safety configuration makes recited subject-matter obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as a matter of minor modification or as a matter of design choice (see MEPE 2144.04) in order to derive a device that offers functionally equivalent protection and ease of operation of the enclosed medical device (Dufresne, col. 6 lines 9-10)).
As per dependent Claim 3, the Dufresne as evidenced by Kulstad as a whole further discloses protection device wherein the distal part of the body is formed by a double cylindrical wall (see fig. 2-3, abstract “tubular housing (4) as well as a double-ended cannula (16) mounted within the housing”; col. 2 lines 47-48 “cannula 16 extends so as to be axially aligned with the housing 4” i.e. coaxial ).
As per dependent Claim 5, the Dufresne as evidenced by Kulstad as a whole further discloses protection device wherein the assembly means of the body and the complementary assembly means of the tube are capable of immobilizing the body irreversibly in longitudinal translation in the second position (fig. 2-3, col. 3 lines 6-31 discloses assembly means of the body 24 and the complementary assembly means 26 of the tube are capable of immobilizing the body irreversibly in longitudinal translation in the second position).
As per dependent Claim 6, the Dufresne as evidenced by Kulstad as a whole further discloses protection device wherein the assembly means of the body comprise a first slot and a second slot (col. 3 lines 6-31 “two slots 24”), the complementary assembly means of the tube comprise a stud (col. 3 lines 6-31 boss 26), said stud being capable of nesting in the first slot when the protection device is in the sampling configuration (fig. 2) and nesting in the second slot when the protection device is in the protection configuration (fig. 3).
As per dependent Claim 8, the Dufresne as evidenced by Kulstad as a whole further discloses protection device wherein the assembly means of the body comprise means for guiding in translation and immobilizing in rotation capable of engaging with complementary means for guiding in translation and immobilizing in rotation of the tube when said body is in the first position or in the second position, so as to immobilize the body in rotation about a longitudinal axis and to guide the sliding of the body on the tube (fig. 2-3, abstract, ref. ele. 26, col. 3 lines 6-31 for example discloses the assembly means 24 of the body comprise means/slots for guiding in translation and immobilizing in rotation capable of engaging with complementary means/boss for guiding in translation and immobilizing in rotation of the tube when said body is in the first position or in the second position, so as to immobilize the body in rotation about a longitudinal axis and to guide the sliding of the body on the tube. See at least abstract “holder (2) includes a tubular housing (4) as well as a double-ended cannula (16) mounted within the housing (4) for slidably moving between an extended distal position, wherein the cannula (16) projects from the housing (4) and is exposed…and a retracted proximal position, wherein the cannula (16) is safely located within the housing (4)”; col. 3 lines 6-31 “slot 24 for sliding engagement by a respective radial boss 26 extending from the carrier 18”).
As per dependent Claim 9, the Dufresne as evidenced by Kulstad as a whole further discloses protection device wherein the tube comprises fastening means (fig. 2-3, ref. ele. 18, col. 2 lines 47-50) capable of fastening the tube on the medical device (fig. 2-3).
As per dependent Claim 10, the Dufresne as evidenced by Kulstad as a whole further discloses protection device wherein the body (fig. 2, ref. ele. 4) comprises a proximal part communicating with the distal part via an interface opening 12 said proximal part having an internal cross section narrowing in certain body longitudinal portions towards said interface opening (col. 2 lines 35-41 “ outer tubular housing 4 …defines a cylindrical sleeve or barrel which extends to another end of the housing… coaxial aperture 12 is formed within a central boss 14, provided on the outer surface of the end wall 10.”).
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Dufresne as evidenced by in view of Toner et al. (Pub. No.: US 20130260452 A1, hereinafter referred to as “Toner”).
As per dependent Claim 4, Dufresne as evidenced by Kulstad discloses protection device according to claim 1 (see claim 1), wherein the protection device comprises a hollow cylinder arranged in the distal part of the body (see fig. 2-3 “housing 4 defines a cylindrical sleeve or barrel which extends to another end of the housing”)
Dufresne as evidenced by Kulstad does not explicitly disclose high thermal conductivity feature i.e. cylinder being produced from a material having a high thermal conductivity
However, in an analogous medical device field of endeavor, Toner discloses a medical sample collection device comprising a cylinder being produced from a material having a high thermal conductivity (Toner in at least [0008], [0014] discloses medical device comprising a sample collector that is shaped like a cylinder and produced from a material having a high thermal conductivity. See at least[0014] “tube can be made of any thermally conductive material including, but not limited to, plastic, glass, quartz, stainless steel, sapphire, gold, silver, copper, diamond, titanium, palladium, and platinum.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the body hollow cylinder of the protection device for medical device as taught by Dufresne, by further ensuring the body hollow cylinder is produced from a material having a high thermal conductivity, as taught by Kulstad. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of extending protection such as protecting cells from injury, maintaining their viability, and, in the case of embryonic stem cells, maintaining their pluripotency to mammalian cells to other cells such as adult stem cells, embryonic stem cells, oocytes, sperm, embryos, zygotes, and other types of cells (Toner, [0008]).
As per dependent Claim 17, the combination of Dufresne (as evidenced by Kulstad) and Toner as a whole further discloses protection device wherein the material having a high thermal conductivity is aluminium (Examiner notes that instant application as-filed is silent as to the criticality of specific high thermal conductivity material recited as evidenced in instant application as-filed page 12 lines 31-33. Consequently, Toner’s disclosure in [0008], [0014] of a sample collector that is shaped like a cylinder and produced from a material having a high thermal conductivity such as gold, silver, copper, diamond, titanium, palladium, and platinum reads on the subject-matter as now explicitly, positively and specifically recited by the Applicants. See at least [0014] “tube can be made of any thermally conductive material including, but not limited to, plastic, glass, quartz, stainless steel, sapphire, gold, silver, copper, diamond, titanium, palladium, and platinum.”).
Contingently Allowable Subject-Matter
As per dependent claims 7, 11, dependent claims 7, 11 would be contingently 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 in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 12-16, 18, dependent claims 12-16, 18 would be contingently 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 in addition to overcoming any other rejections/objections enumerated above.
Additionally, as per dependent claims 12-16, 18, dependent claims 12-16, 18 are being objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per independent Claim 7, the prior art of record fails to disclose or render obvious protection device wherein said stud comprises a stop face abutting against stop faces respectively of the first and second slots when the body is respectively in the first and second positions, the stop face of the first slot being inclined with respect to the stop face of the stud so as to allow sliding of the body from the first position to the second position, the stop face of the second slot being parallel to the stop face of the stud so as to immobilize the body irreversibly in the second position including all the other features, structures, steps, specific arrangement and combination of features, structures and steps in dependent claim 7 including all of the limitations of the respective base claim and any intervening claims.
As per independent Claim 11, the prior art of record fails to disclose or render obvious a medical transfer assembly comprising the protection device according to claim 1 and a transfer device, said transfer device comprising a catheter and a syringe mounted at a proximal end of the catheter, said transfer device being arranged partly in the tube of the protection device, said catheter comprising a hollow conduit, a distal portion of the conduit extending beyond the distal part of the body so as to be situated outside the protection device when the protection device is in the sampling configuration, said distal portion of the conduit being arranged inside the distal part of the body when the protection device is in the protection configuration including all the other features, structures, steps, specific arrangement and combination of features, structures and steps in dependent claim 11 including all of the limitations of the respective base claim and any intervening claims.
However, none of the prior art discloses or renders obvious all the features, structures, steps, specific arrangement and combination of features, structures and steps as in dependent claim 7 and claim 11.
Additionally, as per dependent claims 12-16, 18 would be contingently allowable based on their direct/indirect dependency on respective contingently allowable base claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20100016799 A1 to Schweitzer et al. for disclosing medical protection device similar to that disclosed.
Prior art US 20030208101 A1 to Cecchi for disclosing an embryo transfer catheter assembly, which includes an outer guide cannula, and an inner catheter, which is slidably disposed in a bore in the guide cannula similar to that disclosed. The catheter includes a soft distal end, which carries the embryo, and a more rigid outer cannula, which protects the inner catheter during use.
Prior art US 20190083135 A1 to Alvarez discloses transfer assembly includes a protective element and a carrier element similar to that disclosed. The protective element includes a pliable, hollow protective valve member having a pivot cutaway portion. A tubular member of the protective element depends from a surface of the hollow protective valve member. The protective valve member is configured to define a stop for limiting the insertion of the tubular member.
Prior art US 20040092791 A1 to Bateman et al. discloses apparatus for use in handling an oocyte or embryo including a tube adapted for use in the handling of the oocyte or embryo and an elongate jacket extending along the tube, the jacket being arranged to maintain the temperature within the tube. This prior art is similar in terms of providing flexible thermally insulating jackets/portions on protection device to that disclosed.
Prior art US 20020111562 A1 to Richards discloses cellular collection apparatus and method for collecting a nonintrusive cell or tissue sample for medical procedures similar to that disclosed.
Prior art US 20160143631 A1 to Zavala discloses biological sample collector similar to that disclosed that has an internal collection assembly disposed within the outer body of absorbent material. The internal collection assembly includes a funnel having an opening at the distal end of the outer body configured to face the uterine cervix when the outer body is positioned in the vaginal cavity, and a reservoir in fluid communication with the funnel.
Prior art US 6610005 B1 to Tao discloses catheter system utilizing a protective catheter sleeve for introducing a catheter for embryo protection and deposit similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791