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 .
Response to Amendment
The amendment filed 27 January 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: claim 27 recites "the distal or tip portion being operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage". In Applicant’s remarks regarding claim 27, Applicant fails to cite where in the specification it is disclosed the distal or tip portion is operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage. As such, it appears that the specification is devoid of any disclosure that the distal or tip portion is operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage.
Applicant is required to cancel the new matter in the reply to this Office Action.
Response to Arguments
Applicant’s arguments, see page 8 of applicant’s remarks, filed 27 January 2025, regarding the finality of the previous Office Action, have been fully considered and are persuasive. Applicant is correct that the previous Office Action of 09/27/2024 introduced a new grounds of rejection that was not necessitated by amendment as claim 1 merely incorporated the subject matter of claim 10. Therefore, the previous Office Action is not deemed final and a new non-final rejection (this current Office Action) is being issued.
Applicant’s arguments, see remarks, filed 27 January 2025, with respect to the rejection(s) of claim(s) 1, under 35 USC 102 & 103 as being unpatentable over McSherry and McSherry as modified by Staton, Slowey, McMillan and Giddings have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that discloses a swab enclosed in a sleeve/cage that collects/dislodges specimen.
Applicant’s arguments with respect to claim(s) 30, 31, 32, 34-36 & 48 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument (i.e., regarding Applicant’s arguments of the inapplicability of the McSherry reference).
Moreover, some of Applicant’s arguments, see remarks, filed 27 January 2025, are unpersuasive. Regarding Applicant’s argument that McSherry does not teach the swab head is fixed within the sheath, the Examiner notes that Applicant is introducing new matter into the disclosure since the disclosure does not describe the distal or tip portion of the collection swab is operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage. Therefore, Applicant’s argument that the McSherry reference does not teach the aforementioned limitation is moot because the disclosure does not support the aforementioned limitation, and further because the McSherry referenced is no longer relied upon.
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 27 & 36 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.
Claim 27 has been amended to recite "the distal or tip portion being operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage". In Applicant’s remarks regarding claim 27, Applicant fails to cite where in the specification it is disclosed the distal or tip portion is operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage. As such, it appears that the specification is devoid of any disclosure that the distal or tip portion is operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage. Therefore, the scope of the sleeve/cage and the collection swab is unclear because these newly added limitations present a new scope of the sleeve/cage and the collection swab.
Furthermore, claim 36 recites “wherein the plurality of supports are located on at least two different points on the cage or sleeve parallel with the distal or tip portion”. It appears that the specification is devoid of any disclosure that the plurality of supports are located on at least two different points on the cage or sleeve parallel with the distal or tip portion. Therefore, the scope of the plurality of supports of the sleeve or cage is unclear because there is a discrepancy between claim 36 and the disclosure of the claimed features of the plurality of supports.
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, 21-36 & 38-39 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 recites “a handle portion located at a proximal end of the collection swab, the handle portion configured to maneuver the collection swab within a desired location” [emphasis added] at lines 2-3 and “wherein the sleeve or cage is configured to dislodge and collect the specimen from a desired location as a surface of the sleeve or cages comes into contact with the desired location, the specimen being passed into the sleeve or cage to the distal or top portion” [emphasis added] at lines 7-9. It is unclear whether the “a desired location” at line 3 of the claim is the same as or different than the “a desired location” at lines 7-8 of the claim. For examination purposes, it will be interpreted that the “a desired location” at lines 3 and 7-8 are reciting the same desired location. The Examiner suggests Applicant amends lines 7-8 to recite “the desired location”.
Furthermore, claim 1 recites “wherein the sleeve or cage is configured to dislodge and collect the specimen” [emphasis added] at line 7 and “wherein the distal or tip portion is configured to capture the specimen” [emphasis added] at line 10. It is unclear how dislodging and collecting specimen is different from capturing specimen. The examiner respectfully requests clarification of how “dislodging and collecting” specimen with the sleeve or cage is different than “capturing” specimen with the distal or tip portion. For examination purposes, it will be interpreted that the sleeve or cage scrapes/abrades specimen into a biological fluid that is then absorbed/retained within the distal or tip portion of the collection swab.
Claim 27 recites “wherein the sleeve or cage partially encompasses the distal or tip portion, the distal or tip portion being operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage” [emphasis added]. It is unclear how the distal or tip portion can be operationally fixed in position relative to the sleeve or cage and simultaneously operationally fixed within the sleeve or cage. For example, if the distal or tip portion is operationally fixed in a position distal from the sleeve or cage (i.e., the distal or tip portion is fixed away from the sleeve or cage during operation) the same sleeve or cage cannot be operationally fixed within the sleeve or cage. Therefore, for examination purposes, it will be interpreted that the distal or tip portion is either operationally fixed in position relative to the sleeve or cage or operationally fixed within the sleeve or cage.
Claim 29 recites “wherein the sleeve or cage is made of a material that is configured to collect and retain material from a desired location from a patient, and wherein retrieval of the material is performed from the sleeve or cage via use of centrifugal force” [emphasis added]. It is unclear whether the “a desired location” recited in the claim is the same as or different than the desired location recited in claim 1. For examination purposes, it will be interpreted that the “a desired location” of claim 29 is the same as the desired location of claim 1. The Examiner suggests Applicant amends claim 29 to recite “the desired location”.
Furthermore, the claim recites that the sleeve or cage is made of a material and is configured to collect and retain material from the desired location. As a result, it is unclear which “material” is retrieved via the use of centrifugal force. For examination purposes, it will be interpreted that the sleeve or cage is made of a material that is configured to collect and retain specimen from the desired location from a patient, and that the specimen is retrieved from the sleeve or cage via use of centrifugal force. The Examiner suggests Applicant amends the second and last instance of “material” in claim 29 to recite “the specimen”.
Claim 34 recites “the plurality of openings or passages” at lines 1-2. There is insufficient antecedent basis in the claim for “the plurality of openings or passages”, therefore it is unclear as to what plurality of openings or passages the claim is referring. For examination purposes, it will be interpreted that a size for each of a plurality of openings or passages is based on a spacing between the adjacent ribs of the plurality of ribs.
Claim 36 recites “wherein the plurality of supports are located on at least two different points on the cage or sleeve parallel with the distal or tip portion” [emphasis added]. It is unclear what this claim limitation is referring to, particularly regarding how the plurality of supports on the sleeve or cage are “parallel” with the distal or tip portion, as that seems to mean the plurality of supports are parallel to, and therefore not touching the distal or tip portion encompassed within the sleeve or cage, but the claim recites the plurality of supports are on the sleeve or cage portion. The Examiner respectfully requests clarification of this claim limitation. For examination purposes, it will be interpreted that the plurality of supports are parallel with the shaft of the collection swab, as demonstrated in fig. 14A and paragraphs 0034, 0062 of the instant application.
Claim 38 recites “wherein the sleeve or cage further comprises a braid arranged to configure the sleeve or cage to have one or more of a pre-determined capture rate, a pre-determined absorption rate, a pre-determined retention, or a pre-determined release”. It is unclear how the braid of the sleeve or cage configures the sleeve or cage to have one or more of a pre-determined capture rate, a pre-determined absorption rate, a pre-determined retention, or a pre-determined release because that would imply that there is a certain amount per unit of time the sleeve or cage is capable of sampling, but that can also be a function of the sampling location (i.e., the viscosity of the biological fluid of the desired location), and user movement (i.e., how the collection swab is maneuvered in the desired location). Furthermore, with respect to “pre-determined retention” or “pre-determined release”, it is unclear if that is referring to the amount of specimen retained, the timing of sampling or the desired location of sampling. The Examiner respectfully requests clarification of these claim limitations. For examination purposes, it will be interpreted that a pre-determined capture rate, a pre-determined absorption rate, a pre-determined retention, or a pre-determined release means the collection swab intrinsically has its own absorption/capture/retention rate based upon the design of the sleeve or cage and distal or tip portion of the collection swab, the sampling location, and how the collection swab is maneuvered withing the sampling location. Claim 39 is similarly rejected and interpreted.
Dependent claims are similarly rejected as their base claim.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication 20030028123, hereinafter referenced as "Pevoto".
With respect to claim 1, Pevoto teaches a collection swab 10 (i.e., an intra-vaginal self-administered cell collecting device) comprising (see figs. 1 & 2):
a handle portion 18 (i.e., a flexible retrieval member) located at a proximal end of the collection swab (see par 0019, figs. 1 & 2), the handle portion configured for a user to maneuver the collection swab within a desired location (see par 0019);
a distal or tip portion 14 (i.e., an absorbent member) connected to the handle portion 18 via a shaft portion (i.e., the shaft of the flexible retrieval member) and configured to collect a specimen from the desired location (see figs. 1 & 2, par 0016-0019),
and a sleeve or cage 16 (i.e., a textured cover that abrades vaginal tissue to slough off cells into the vaginal fluid that is then absorbed by the absorbent member) that encompasses the distal or tip portion of the collection swab (see figs. 1 & 2), wherein the sleeve or cage is configured to dislodge and collect the specimen from a desired location as a surface of the sleeve or cage comes into contact with the desired location, the specimen being passed into the sleeve or cage to the distal or tip portion (see par 0016 -0020, figs. 1 & 2), wherein the distal or tip portion is configured to capture the specimen from the desired location as the collection swab is maneuvered within the desired location and retain the specimen when the collection swab is removed from the desired location (see par 0016 -0020, figs. 1 & 2).
Claim Rejections - 35 USC § 103
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(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pevoto in view of US Patent Application Publication 20190118172 –as previously cited--, hereinafter referenced as "Staton".
With regards to claim 21, Pevoto teaches the collection swab of claim 1. Pevoto does not teach that the distal or tip portion is removably connected to the shaft portion of the collection swab, and wherein the removability is provided via a break portion in the shaft portion between the distal or tip portion and the handle portion.
Staton teaches that a distal or tip portion 34 of a sample collecting swab 14 is removably connected to a shaft portion 32 (i.e., an elongate rigid stem) of the swab 14 via a break portion 60 in the shaft portion 32 that is between the distal or tip portion 34 and the handle portion (i.e., the posterior of the elongate rigid stem) (see Staton, par 0017 & 0032, figs. 9 & 10).
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 collection swab of Pevoto such that the swab comprises a break portion in the shaft portion of the swab between the distal or tip portion and the handle portion of the swab because a break portion improves the collection swab of Pevoto by facilitating the separation of collected specimen in the tip portion of the swab from the handle portion of the swab once sampling has been completed for storage (see Staton, par 0032).
Claim(s) 22-32 & 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pevoto in view of Staton as applied to claim 21 above, and further in view of US Patent Application Publication 20100137741 --as previously cited-- hereinafter referenced as "Slowey".
With respect to claims 22 & 23, Pevoto in view of Staton teaches the collection swab of claim 21. Pevoto in view of Staton teaches that the distal or tip portion of the collection swab comprises an interior structure that provides retention of collected specimen (i.e., the intra-vaginal self-administered cell collecting device contains an absorbent member contained within a textured cover that absorbs vaginal fluid) (see Pevoto, par 0016-0020, figs. 1 & 2).
Pevoto in view of Staton does not teach that the distal or tip portion of the collection swab comprises a plurality of protrusions that are spaced apart from each other along a length of the tip portion of the swab, nor that the plurality of protrusions have a through hole located at an outermost tip of that protrusion, wherein the through hole is configured to break surface tensions of surfaces the collection swab comes into contact with, and wherein the through hole is configured to allow collection and retention of the specimen within the protrusion.
Slowey teaches that a distal or tip portion 30 of a multi compartment body part scraping fluid collection device comprises a plurality of protrusions 36, and that each of the plurality of protrusions 36 are spaced apart from each other along a length of the distal or tip portion 30 (see Slowey, fig. 4, par 0051, 0057-0058, 0061-0062). Slowey further teaches that one or more of a plurality of protrusions 36 have a through hole 32 located at an outer-most tip of that protrusion 36, wherein the through hole 32 is configured to break surface tensions of surfaces the collection swab comes into contact with (Slowey, see fig. 4, par 0057-0058 & 0061-0062), and wherein the through hole is configured to allow collection and retention of the specimen within the protrusion (Slowey, fig. 4, par 0057-0058 & 0061-0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the interior absorbent member of the collection swab of Pevoto in view of Staton, with a swab head comprising a plurality of protrusions with through holes, as taught by Slowey, because a swab head comprising a plurality of protrusions with through holes in the interior of the distal or tip portion is a simple substitution of one swab head (the swab head of Slowey) for another (the swab head of Pevoto as modified by Staton) that facilitates more efficient sample collection due to additional scraping or swiping sample containing surfaces by the plurality of protrusions, and sample collection/retainment by the through holes once the surface has been scraped or swiped (see Slowey, par 0061-0062).
With respect to claim 24, Pevoto in view of Staton and in further view of Slowey teaches the collection swab of claim 23. Pevoto in view of Staton and in further view of Slowey fails to teach the collection swab comprises a plurality of protrusions that have a circular shape (i.e., a circular cross-section).
Slowey teaches that a collection swab comprises a plurality of protrusions 36 that have a circular shape (i.e., a circular cross section) (Slowey, see figs. 1-4).
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 tip or distal portion of Pevoto in view of Staton and in further view of Slowey such that the distal or tip portion comprises a plurality of circular shaped protrusions, as taught by Slowey, because the circular shape of the protrusions improves the collection swab of Pevoto in view of Staton and in further view of Slowey, by enclosing the maximum area for a given perimeter (as that is a natural property of circles), thus increasing the area by which specimen is collected in the protrusions of the interior portion of the collection swab.
With respect to claim 25, Pevoto in view of Staton and in further view of Slowey teaches the collection swab of claim 24. Pevoto fails to teach the desired sampling location includes a nasal cavity.
Staton teaches the sample collecting swab is used for testing surfaces, such as surfaces of the nasal cavity (Staton, see par 0014, 0031).
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 system of Pevoto such that the desired sampling location includes a nasal cavity because that would permit the testing of microorganisms in a nasal cavity of a subject (see Staton, par 0031).
With respect to claims 26 & 27, Pevoto in view of Staton and in further view of Slowey teaches the collection swab of claim 23. Pevoto further teaches the sleeve or cage 16 (i.e., textured) partially and entirely encompasses the distal or tip portion of the collection swab, the distal or tip portion being operationally fixed in position relative to the sleeve or cage and operationally fixed within the sleeve or cage (i.e., the textured cover fully covers the absorbent member or is only a molded portion of the absorbent member, wherein the absorbent member is fixed within the textured cover) (Pevoto, see par 0016-0018, claims 1-5).
With respect to claim 28, Pevoto in view of Staton and in further view of Slowey teaches the collection swab of claim 26.
Pevoto further teaches that the sleeve or cage 16 (i.e., textured cover) has a plurality of openings or passages configured to provide access to the distal or tip portion contained therein, and wherein the specimen is passed to the distal or tip portion via the plurality of openings or passages (Pevoto, see figs. 1 & 2, par 0016-0020).
With respect to claim 29, Pevoto as modified by Staton and Slowey teach the collection swab of claim 28.
Pevoto further teaches the sleeve or cage is made of a material that is configured to collect and retain material from a desired location from a patient (i.e., the textured cover is textured to be mildly abrasive for sloughing off cells) (see Pevoto, par 0017).
Pevoto as modified by Staton fails to teach retrieval of the material is performed from the sleeve or cage via use of centrifugal force.
Slowey teaches centrifugation is a known method for removing samples from an absorbent material (see Slowey, par 0014).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to retrieve material from the sleeve or cage via the use of centrifugal force, as centrifugation is a known method for removing samples from absorbent materials (see Slowey, par 0014).
With respect to claims 30-32 & 38, Pevoto as modified by Staton and Slowey teaches the collection swab of claim 26.
Pevoto further teaches the sleeve or cage comprises a plurality of ribs that run perpendicular to the shaft portion and a plurality of supports that run parallel with the shaft portion (see Pevoto, figs. 1 & 2).
Pevoto as modified fails to teach the plurality of supports form perpendicular connections that resemble a “plus” sign at a distal most end of the sleeve or cage, the plurality of ribs are paddle-shaped, nor the sleeve or cage comprises a braid arranged to configure the sleeve or cage to have one or more of a pre-determined capture rate, a pre-determined absorption rate, a pre-determined retention, or a pre-determined release.
Nonetheless, it would be an obvious design choice to a person of ordinary skill in the art to
modify the shape of the sleeve or cage such that the plurality of supports form perpendicular connections that resemble a “plus” sign at a distal most end of the sleeve or cage, the plurality of ribs are paddle-shaped, and wherein the sleeve or cage comprises a braid arranged to configure the sleeve or cage to have one or more of a pre-determined capture rate, a pre-determined absorption rate, a pre-determined retention, or a pre-determined release. One of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the claimed shape of the sleeve or cage having the aforementioned features with the collection swab of the cited prior art because both provide the same or similar predictable results, e.g. making contact with a sample surface to retain a sample in an interior portion of a collection swab. See MPEP section 2144.04 IV. B. Changes in Shape.
Furthermore, it would be an obvious design choice to a person of ordinary skill in the art to modify the sleeve or cage such that the sleeve or cage has one or more of a pre-determined capture rate, a pre-determined absorption rate, a pre-determined retention, or a pre-determined release because one of ordinary skill in the art would have, through routine optimization, configured the shape of the sleeve or cage to have one or more of a pre-determined capture rate, a pre-determined absorption rate, a pre-determined retention, or a pre-determined release. Additionally, par 0018 of Pevoto provides a clear teaching that routine optimization is possible to determine the desired dimensions and shape of the textured cover based upon the desired factors of porosity to permit fluid to pass through to the absorbent member, texture for sloughing off cells/microorganisms, and shape for retaining the absorbent member.
Claim(s) 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pevoto in view of Staton and Slowey, as applied to claim 31 above, and further in view of US Patent 8641642 --as previously cited--, hereinafter referenced as "Giddings".
With respect to claim 33, Pevoto as modified teaches the collection swab of claim 31. Pevoto as modified does not teach that the distal or tip portion comprises a bolster and associated indents configured to attach to the sleeve or cage to the distal or tip portion, wherein the bolster and associated indents are located at a proximal end of the distal or tip portion.
Giddings teaches a collection swab 10 with a bolster 44 and associated indents 28 configured to attach to a distal end of the collection swab, the bolster 44 and associated indents 28 located at a proximal end of the collection swab (i.e., a mechanism that provides a snap-fit of the collection swab to a sleeve, cap, vial, etc.) (Giddings, see fig. 4A & 4B, Col 7, lines 33-49).
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 distal or tip portion of the collection swab of Pevoto as modified such that it comprises a bolster with associated indents because a bolster with indents enables the sleeve or cage it to be removed from the interior portion of the collection swab via the bolster and indents (Giddings, see fig. 4A & 4B, Col 7, lines 33-49).
With respect to claims 34-36, Pevoto as modified by Staton, Slowey and Giddings teaches the collection swab of claim 33.
Pevoto further teaches the plurality of supports are located on at least two different points on the cage or sleeve parallel with the distal or tip portion (i.e., the plurality of supports are parallel with the shaft of the collection swab) (see Pevoto, figs. 1 & 2), and a size for each of a plurality of opening or passages is based on a spacing between the adjacent ribs of the plurality of ribs (i.e., the sizing of the openings of the textured cover is based on the spacing of the mesh) (see Pevoto, figs. 1 & 2, par 0016-0018).
Pevoto as modified fails to teach the sleeve or cage further comprises protrusions corresponding to where the plurality of supports and the plurality of ribs are connected to each other.
Nonetheless, it would be an obvious design choice to a person of ordinary skill in the art to
modify the shape of the sleeve or cage such that there are protrusions corresponding to where the plurality of supports and the plurality of ribs are connected to each other. One of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the claimed shape of the sleeve or cage having the aforementioned features with the collection swab of the cited prior art because both provide the same or similar predictable results, e.g. making contact with a sample surface to retain a sample in an interior portion of a collection swab. See MPEP section 2144.04 IV. B. Changes in Shape.
Claim(s) 39 & 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pevoto in view of Slowey, in further view of Giddings.
With respect to claim 39, Pevoto teaches a collection swab 10 (i.e., an intra-vaginal self-administered cell collecting device) comprising (see Pevoto, figs. 1 & 2) comprising:
a handle 18 (i.e., a flexible retrieval member) located at a proximal end of the collection swab (see Pevoto, par 0019, figs. 1 & 2), the handle portion configured for a user to maneuver the collection swab within a desired location (see Pevoto, par 0019);
a tip 14 (i.e., an absorbent member) connected to the handle portion 18 via a shaft portion (i.e., the shaft of the flexible retrieval member) and configured to collect a specimen from the desired location (see Pevoto, figs. 1 & 2, par 0016-0019),
and a removable sleeve 16 (i.e., a textured cover that abrades vaginal tissue to slough off cells into the vaginal fluid that is then absorbed by the absorbent member) that encompasses the tip (see Pevoto, figs. 1 & 2), wherein the removable sleeve comprises a plurality of openings configured to provide access to the tip contained therein, wherein removable sleeve is configured to capture the specimen from the desired location as the collection swab is maneuvered within the desired location and retain the specimen when the collection swab is removed from the desired location, and wherein specimen is passed to the tip through the plurality of openings (see Pevoto, par 0016 -0020, figs. 1 & 2).
Pevoto does not teach the tip comprises a plurality of protrusions having a through hole configured to collect and retain the specimen therein, the removable sleeve comprises a proximal support ring comprising apertures, the removable sleeve comprises one or more braids having a pre-determined absorption rate and a pre-determined release rate, nor that the tip comprises indents configured to interface with the apertures of the proximal support ring of the removable sleeve, the indents located at a proximal end of the tip.
Slowey teaches that a distal or tip portion 30 of a multi compartment body part scraping fluid collection device comprises a plurality of protrusions 36, and that each of the plurality of protrusions 36 are spaced apart from each other along a length of the distal or tip portion 30 (see Slowey, fig. 4, par 0051, 0057-0058, 0061-0062).Slowey further teaches that one or more of a plurality of protrusions 36 have a through hole 32 located at an outer-most tip of that protrusion 36, wherein the through hole 32 is configured to break surface tensions of surfaces the collection swab comes into contact with (Slowey, see fig. 4, par 0057-0058 & 0061-0062), and wherein the through hole is configured to allow collection and retention of the specimen within the protrusion (Slowey, fig. 4, par 0057-0058 & 0061-0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the interior absorbent member of the collection swab of Pevoto, with a plurality of protrusions with through holes, as taught by Slowey, because a plurality of protrusions with through holes in the interior of the distal or tip portion is a simple substitution of one swab head (the swab head of Slowey) for another (the swab head of Pevoto) that facilitates more efficient sample collection due to scraping or swiping sample containing surfaces by the plurality of protrusions, and sample collection/retainment by the through holes once the surface has been scraped or swiped (see Slowey, par 0061-0062).
Pevoto in view of Slowey does not teach the removable sleeve comprises a proximal support ring comprising apertures, the removable sleeve comprises one or more braids having a pre-determined absorption rate and a pre-determined release rate, nor that the tip comprises indents configured to interface with the apertures of the proximal support ring of the removable sleeve, the indents located at a proximal end of the tip.
Giddings teaches a collection swab 10 with a bolster 44 and associated indents 28 configured to attach to a distal end of the collection swab, the bolster 44 and associated indents 28 located at a proximal end of the collection swab (i.e., a mechanism that provides a snap-fit of the collection swab to a sleeve, cap, vial, etc.) (Giddings, see fig. 4A & 4B, Col 7, lines 33-49).
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 distal or tip portion of the collection swab of Pevoto as modified such that it comprises a bolster with associated indents as taught by Giddings because a bolster with indents enables the sleeve or cage to be removed from the interior portion of the collection swab via the bolster and indents (Giddings, see fig. 4A & 4B, Col 7, lines 33-49).
Pevoto as modified by Slowey and Giddings fails to teach that the removable sleeve comprises one or more braids having a pre-determined absorption rate and a pre-determined release rate. However, it would be an obvious design choice to a person of ordinary skill in the art to modify the sleeve or cage such that it comprises one or more braids having a pre-determined absorption rate and a pre-determined release rate because one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the claimed shape of the sleeve or cage having the aforementioned features with the collection swab of the cited prior art because both provide the same or similar predictable results, e.g. making contact with a sample surface to retain a sample in an interior portion of a collection swab. See MPEP section 2144.04 IV. B. Changes in Shape.
With respect to claim 40, Pevoto teaches a collection swab 10 (i.e., an intra-vaginal self-administered cell collecting device) comprising (see Pevoto, figs. 1 & 2) comprising:
a handle 18 (i.e., a flexible retrieval member) located at a proximal end of the collection swab (see Pevoto, par 0019, figs. 1 & 2), the handle portion configured for a user to maneuver the collection swab within a desired location (see Pevoto, par 0019);
a tip 14 (i.e., an absorbent member) connected to the handle portion 18 via a shaft portion (i.e., the shaft of the flexible retrieval member) and configured to collect a specimen from the desired location (see Pevoto, figs. 1 & 2, par 0016-0019),
and a removable sleeve 16 (i.e., a textured cover that abrades vaginal tissue to slough off cells into the vaginal fluid that is then absorbed by the absorbent member) that encompasses the tip (see Pevoto, figs. 1 & 2), wherein the removable sleeve comprises a plurality of openings configured to provide access to the tip contained therein, wherein removable sleeve is configured to capture the specimen from the desired location as the collection swab is maneuvered within the desired location and retain the specimen when the collection swab is removed from the desired location, and wherein specimen is passed to the tip through the plurality of openings (see Pevoto, par 0016 -0020, figs. 1 & 2).
Pevoto further teaches the sleeve or cage comprises a plurality of ribs that run perpendicular to the shaft portion and a plurality of supports that run parallel with the shaft portion (see Pevoto, figs. 1 & 2), wherein the plurality of supports are located on at least two different points on the cage or sleeve parallel with the distal or tip portion (see Pevoto, figs. 1 & 2), , wherein the plurality of ribs are arranged over the tip encompassed by the sleeve, the distal most point of the sleeve disposed adjacent to the distal most point of the tip (see Pevoto, figs. 1 & 2), wherein the plurality of ribs and the plurality of supports are arranged to form a plurality of passageways, wherein the plurality of passageways are configured to pass the specimen therethrough to the tip encompassed therein (see Pevoto, figs. 1 & 2, par 0016-0018), and wherein a size for each of a plurality of opening or passages is based on a spacing between the adjacent ribs of the plurality of ribs (i.e., the sizing of the openings of the textured cover is based on the spacing of the mesh) (see Pevoto, figs. 1 & 2, par 0016-0018).
Pevoto does not teach the tip comprises a plurality of protrusions having a through hole configured to collect and retain the specimen therein, the plurality of supports curving at a distal end of the sleeve and intersecting at a distal most point of the sleeve, and a support ring comprising a plurality of apertures configured to interface with the plurality of indents to attach the sleeve to the proximal end of the tip, and wherein at least one of the plurality of circular protrusions has its through hole aligned within an opening defined by at least one of the plurality of passageways formed.
Slowey teaches that a distal or tip portion 30 of a multi compartment body part scraping fluid collection device comprises a plurality of protrusions 36, and that each of the plurality of protrusions 36 are spaced apart from each other along a length of the distal or tip portion 30 (see Slowey, fig. 4, par 0051, 0057-0058, 0061-0062).Slowey further teaches that one or more of a plurality of protrusions 36 have a through hole 32 located at an outer-most tip of that protrusion 36, wherein the through hole 32 is configured to break surface tensions of surfaces the collection swab comes into contact with (Slowey, see fig. 4, par 0057-0058 & 0061-0062), and wherein the through hole is configured to allow collection and retention of the specimen within the protrusion (Slowey, fig. 4, par 0057-0058 & 0061-0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the interior retention means of the collection swab of Pevoto, with a plurality of protrusions with through holes, as taught by Slowey, because a plurality of protrusions with through holes in the interior of the distal or tip portion is a simple substitution of one swab head (the swab head of Slowey) for another (the swab head of Pevoto) that facilitates more efficient sample collection due to scraping or swiping sample containing surfaces by the plurality of protrusions, and sample collection/retainment by the through holes once the surface has been scraped or swiped (see Slowey, par 0061-0062).
Pevoto in view of Slowey does not teach the plurality of supports curve at a distal end of the sleeve and intersect at a distal most point of the sleeve, a support ring comprising a plurality of apertures configured to interface with the plurality of indents to attach the sleeve to the proximal end of the tip, and wherein at least one of the plurality of circular protrusions has its through hole aligned within an opening defined by at least one of the plurality of passageways formed.
Giddings teaches a collection swab 10 with a bolster 44 and associated indents 28 configured to attach to a distal end of the collection swab, the bolster 44 and associated indents 28 located at a proximal end of the collection swab (i.e., a mechanism that provides a snap-fit of the collection swab to a sleeve, cap, vial, etc.) (Giddings, see fig. 4A & 4B, Col 7, lines 33-49).
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 distal or tip portion of the collection swab of Pevoto as modified such that it comprises a bolster with associated indents as taught by Giddings because a bolster with indents enables the sleeve or cage to be removed from the interior portion of the collection swab via the bolster and indents (Giddings, see fig. 4A & 4B, Col 7, lines 33-49).
Pevoto as modified by Slowey and Giddings fails to teach the plurality of supports curve at a distal end of the sleeve and intersecting at a distal most point of the sleeve, and wherein at least one of the plurality of circular protrusions has its through hole aligned within an opening defined by at least one of the plurality of passageways formed. However, it would be an obvious design choice to a person of ordinary skill in the art to modify the sleeve or cage such that it the plurality of supports curve at a distal end of the sleeve and intersect at a distal most point of the sleeve, and wherein at least one of the plurality of circular protrusions has its through hole aligned within an opening defined by at least one of the plurality of passageways formed because one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the features of the cited prior art because both provide the same or similar predictable results, e.g. making contact with a sample surface to retain a sample in an interior portion of a collection swab. See MPEP section 2144.04 IV. B. Changes in Shape.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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, Charles Marmor II can be reached on (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.J.C./ Examiner, Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, RD00