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 with traverse of Invention I, Claims 1-11, in the reply filed on 02/04/2026 is acknowledged. The traversal is on the ground(s) that the prior art reference of Kim does not disclose the technical feature of the applicant’s invention, and that Kim does not disclose a diagnostic patch.
This is found not persuasive as the arguments presented are directed towards the general nature of the invention without pointing towards the technical limitations. As indicated in the previous restriction, filed 11/04/2025, the examiner found that the indicated technical features were disclosed within the prior art. The applicant appears to indicate within the response, filed 02/04/2026, that that diagnostic patch of the present inventors is reflected in a patch that comprises two compartments (Page 4 of applicants arguments, filed 02/04/2026). However, as stated above, these arguments are directed towards the general nature of the invention without explicitly pointing towards the technical limitations. Additionally, while the indicated feature is found in the carrier layer of claim 12, it is not found in the carrier layer of claim 1. Claim 1 recites only an antigen containing compartment found in a carrier layer, while claim 12 recites both compartments being present within the carrier layer itself. As such, the feature indicated by the applicant is not common. In response to applicant's argument that Kim is not directed towards a diagnostic patch, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Kim discloses the structures as indicated in the previous restriction, filed 11/04/2025 (Examiner's Note: See also the 103 rejection below). As such, the applicant’s arguments are deemed as not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
(Examiner's Note: If the claims of Invention II are amended to reflect the common special technical feature as in claim 1, then the examiner would rejoin the nonelected claims upon allowance of the device of claim 1, subject to the requirements outlined below)
(Examiner's Note: All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.)
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 02/04/2026.
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).
Applicant’s cancellation of claim 2 and addition of claim 21, in the response filed 02/06/2026 is acknowledged.
Claims Pending
Claims 1, 3-11, and 21 are currently under examination.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the diagnostic skin patch (Claims 1, 2-11, and 21), permeation enhancer device (Claim 8), glass fiber layer (Claim 9), hydrogel (Claim 10), and microneedles (Claim 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims objected to because of the following informalities:
In claim 1, “degree inflammatory” (line 6), should read -degree of an inflammatory-,
Appropriate correction is required.
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:
Claim 1: The claim limitation “attaching means for the attachment of the patch on the skin surface of the patient” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “attaching” coupled with functional language “means for the attachment of the patch on the skin surface of the patient” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “attaching”,
Claim 1: The claim limitation “a permeation enhancer device that enhances the entry of the antigenic protein(s) to the epidermis” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “enhancer device” coupled with functional language “that enhances the entry of the antigenic protein(s) to the epidermis” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “enhancer device”,
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Adhesive, or equivalents thereof, as described on Page 12 (lines 19-21) of the disclosure filed on 03/20/2023.
Microneedles, or equivalents thereof, as described on Page 7 (lines 21-23) of the disclosure filed on 03/20/2023.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2-11, and 21 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 “wherein, by attaching the skin patch on the skin surface of the human patient, the SARS-CoV-2 antigenic protein enters the epidermis”, which reads as a method step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. (MPEP 2173.05 (p) citing In Re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011)). For examination purposes, this will be interpreted as without the method step.
The term “highly antigenic” in claim 3 is a relative term which renders the claim indefinite. The term “highly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as an antigenic protein.
Claim 4 recites the limitation “wherein the isolated and purified Spike protein or the antigenic fragment thereof lacks the natural cleavage site”, which fails to effectively define the metes and bounds of the claim as claim 3, which claim 4 is dependent on, recites “purified Spike protein and/or an antigenic fragments thereof”. Why has there been a change from a plurality of antigenic fragments, to a singular fragment, when it appears that claim 4 is referring to the same structure. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the antigenic fragments will be interpreted as one of the antigenic fragments from claim 3.
Claim 5 recites “wherein the isolated and purified Spike protein or one or more fragments thereof are produced in either of the following eukaryotic cells: mammalian cells, insect cells”, which reads as a method step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. (MPEP 2173.05 (p) citing In Re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011)). For examination purposes, this will be interpreted as without the method step.
Claim 7 recites the limitation “the recombinant SARS-CoV-2 antigenic protein(s)” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the recombinant SARS-CoV-2 antigenic protein(s)” will be interpreted as being the same protein from claim 1. (Examiner's Note: There was no previous indication as to more than a single antigenic protein in a prior claim).
Claim 8 recites the limitation “the recombinant SARS-CoV-2 antigenic protein(s)” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the recombinant SARS-CoV-2 antigenic protein(s)” will be interpreted as being the same protein from claim 1. (Examiner's Note: There was no previous indication as to more than a single antigenic protein in a prior claim).
Claim 8 recites the limitation “A diagnostic skin patch according to claim 2” in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this claim will be interpreted as being dependent on claim 1, rather than claim 2 (Examiner's Note: Claim 2 was previously canceled).
Claim 9 recites “wherein the matrix includes or consists of a glass fiber layer, onto which the antigen-storing compartment which includes one or more recombinant SARS-CoV-2 antigenic protein(s) dried on”, which reads as a method step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. (MPEP 2173.05 (p) citing In Re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011)). For examination purposes, this will be interpreted as without the method step.
Claim 11 recites the limitation “the permeation enhancer” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this claim will be interpreted as being dependent on claim 8, rather than claim 7. (Examiner's Note: The sole other indication of “permeation enhancer” is in claim 8. As such, it is assumed that this claim was intended to be dependent on claim 8 rather than claim 7).
Claim 21 recites the limitation “a patch according to claim 1 is applied to the skin surface of a human patient” This is a “use” claim that is indefinite, as the applicant fails to effectively define the metes and bounds of the claim. The applicant merely recites the use, without providing further detail as to how the use is practiced, and as such the claim indefinite. For examination purposes, this will be interpreted as if there was sufficient detail provided.
Claim 21 recites the limitation “if the degree of the inflammatory skin reaction in the skin area corresponding to the location of the antigen-carrying compartment exceeds the degree of inflammatory skin reaction in the skin area corresponding to the reference compartment, the presence of a cellular immune response against SARS-CoV-2 virus in the human patient is determined”, which fails to effectively define the metes and bounds of the claim as it is unclear whether the conditions followed by the “if…” statement occurs within the claim. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the “if…” statement will be interpreted as “when…” statement.
Claims 2-11 and 21 are dependent on claim 1, and as such are also rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because single "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. Therefore, the claim is rejected as it does not fall under a statutory category of 35 U.S.C. 101.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 11 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 11 recites the limitation “in which the permeation enhancer device contains microneedles penetrating the epidermis”, which is directed towards a human organism as it requires the epidermis as part of the claim language itself. As such, the claim is rejected.
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 claims are generally directed towards a diagnostic patch for detecting an immune response. The device comprises an antigen containing compartment with SARS-CoV-2 antigenic proteins in a carrier layer, a reference compartment without antigenic proteins, and an adhesive for attaching the patch to the skin of a patient.
Claim(s) 1, 3, 8, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US Pub. No. 20210330951) hereinafter Kim, and further in view of Lederman (US Pub. No. 20220016268) hereinafter Lederman.
Regarding claim 1, Kim discloses Diagnostic skin patch for detecting the cellular immune response against a SARS-CoV-2 virus in a human patient (Par. 58, “In certain embodiments, the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch)…”) (Par. 63, “the vaccine antigen may be a coronavirus vaccine antigen that is used for prophylaxis against a coronavirus, such as SARS-CoV-1, SARS-CoV-2, MERS-CoV, etc…”), substantially comprising:
- an antigen-containing compartment (Par. 58, “In certain embodiments, the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch). The path may also contain other elements to help maintain the desired flow of the drug compound. For example, the drug reservoir may be in fluid communication with a rate control membrane that helps control the flow rate of the drug compound by modulating its pressure downstream from the reservoir.”), containing a matrix comprising a recombinant SARS-CoV-2 antigenic protein (Par. 58, “In certain embodiments, the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch). The path may also contain other elements to help maintain the desired flow of the drug compound. For example, the drug reservoir may be in fluid communication with a rate control membrane that helps control the flow rate of the drug compound by modulating its pressure downstream from the reservoir.”) (Par. 54 (microneedles)) (Par. 63, “…In one particular embodiment, for example, the vaccine antigen may be a coronavirus vaccine antigen that is used for prophylaxis against a coronavirus, such as SARS-CoV-1, SARS-CoV-2, MERS-CoV, etc. Such vaccine antigens may be derived from a coronavirus or other type of virus…”), and
- a carrier layer that carries the antigen-containing compartment (Par. 58, “In certain embodiments, the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch). The path may also contain other elements to help maintain the desired flow of the drug compound. For example, the drug reservoir may be in fluid communication with a rate control membrane that helps control the flow rate of the drug compound by modulating its pressure downstream from the reservoir.”) (Par. 59, (backing material that has an adhesive coating)),
- attaching means for the attachment of the patch on the skin surface of the patient (Par. 59, “the transdermal delivery device may contain additional layers or materials that provide various benefits. For example, the assembly may include an adhesive layer that can help facilitate the attachment of the delivery device to a user's skin during use. Although not required, the adhesive layer is often disposed over the reservoir…”),
wherein, by attaching the skin patch on the skin surface of the human patient (Par. 58, (transdermal delivery of the drug)), the SARS-CoV-2 antigenic protein enters the epidermis (Par. 58, 63, (transdermal delivery of the drug)), where it is able to contact the patient's immune cells against SARS-CoV-2 and elicit an inflammatory cellular immune response in the skin (Par. 63, “In one particular embodiment, the drug compound may include a vaccine antigen, which is a substance that, when introduced to the body stimulates an immune response, such as T-cell activation and/or antibody production for prophylaxis against a virus. Vaccine antigens may include natural intact pathogens (e.g., bacterium or virus), a live attenuated virus, or portions and/or subunits of a pathogen, such as a single virus or bacterium protein. Vaccine antigens can also include cancer antigens or fragments thereof. In one particular embodiment, for example, the vaccine antigen may be a coronavirus vaccine antigen that is used for prophylaxis against a coronavirus, such as SARS-CoV-1, SARS-CoV-2, MERS-CoV…”) (Par. 54,58,59 (the transdermal drug delivery patch is capable of the indicated function)).
Kim fails to explicitly disclose a reference compartment, containing the matrix but not comprising SARS-CoV-2 antigenic protein, for comparing the degree inflammatory skin reaction in the skin area corresponding to the location of the antigen-containing compartment and the skin area corresponding to the reference compartment.
Kim does teach a reference component, containing the matrix (Par. 57, “A plurality of reservoirs may also be employed in certain embodiments for storing multiple materials for delivery. The reservoirs may be positioned adjacent to each other, either in a vertical or horizontal relationship. For instance, a first reservoir may contain a drug compound and a second reservoir may contain an excipient (e.g., delivery vehicle, such as alcohols, water, etc.; buffering agents; and so forth)…”), delivery of a plurality of materials from different compartments (Par. 57, “A plurality of reservoirs may also be employed in certain embodiments for storing multiple materials for delivery. The reservoirs may be positioned adjacent to each other, either in a vertical or horizontal relationship. For instance, a first reservoir may contain a drug compound and a second reservoir may contain an excipient (e.g., delivery vehicle, such as alcohols, water, etc.; buffering agents; and so forth)…”) (Par. 58, “the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch)…”), and drug delivery and analyte detection (Abstract)(Par. 65, “In addition to and/or in lieu of drug delivery, the microneedle assembly may also be employed as a sensor. For example, the microneedle assembly may be used only as a sensor…”) (Par. 66, “Examples of target analytes that the sensor may be used to detect include, but are not limited to, pH or metal ions, proteins, nucleic acids (e.g., DNA, RNA, etc.), drugs, sugars (e.g., glucose), hormones (e.g., estradiol, estrone, progesterone, progestin, testosterone, androstenedione, etc.), carbohydrates, or other analytes of interest…”).
However, Lederman teaches a reference, containing the matrix but not comprising SARS-CoV-2 antigenic protein (Par. 290, “the peptides are tested in a group of subjects by intradermally injecting the pools of peptides and a negative control (only solvent) in the ventral surface of the forearm, about 1 mm to about 2 mm within the dermis. 1 μg of the pools of peptides is injected intradermally in a 0.1 ml solution.” (negative control)), for comparing the degree inflammatory skin reaction in the skin area corresponding to the location of the antigen-containing (Par. 290, “The skin test preparation consists of 3 pools of peptides: (1) peptides of SEQ ID NO: 1-45; (2) peptides of SEQ ID NO: 46-167 and (3) peptides of SEQ ID NO: 168-183. The peptides are tested in a group of subjects by intradermally injecting the pools of peptides and a negative control (only solvent) in the ventral surface of the forearm…”) and the skin area corresponding to the reference (Par. 291, “skin reaction is monitored about 48 to 72 hours post-injection by measuring the longest and midpoint orthogonal diameters of the indurated area in millimeters…”) (Par. 292, “A positive immune reaction in a subject is indicative of the subject having developed a cell-mediated immune response to SARS-CoV-2 and, therefore, has developed cell-mediated immunity against SARS-CoV-2 or has an active SARS-CoV-2 infection. The skin tests may be also correlated with a serological immune response and any symptoms present in the subject.”).
Kim and Lederman are considered to be analogous art to the claimed invention as they are involved with devices on the skin of a user.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kim with that of Lederman to include a reference compartment, containing the matrix but not comprising SARS-CoV-2 antigenic protein, for comparing the degree inflammatory skin reaction in the skin area corresponding to the location of the antigen-containing compartment of Kim and the skin area corresponding to the reference compartment through the combination of references and adding the control of Lederman into an additional reservoir of Kim as it would have yielded the predictable result of providing a comparison to evaluate delayed type hypersensitivity response in a patient (Lederman (Par. 291-292)).
Regarding claim 3, modified Kim further discloses wherein the recombinant SARS-CoV-2 antigenic protein is a highly antigenic, isolated and purified Spike protein and/or an antigenic fragments thereof, that preserved the structure required for antigenicity (Kim (Par. 63, “In one particular embodiment, the drug compound may include a vaccine antigen, which is a substance that, when introduced to the body stimulates an immune response, such as T-cell activation and/or antibody production for prophylaxis against a virus. Vaccine antigens may include natural intact pathogens (e.g., bacterium or virus), a live attenuated virus, or portions and/or subunits of a pathogen, such as a single virus or bacterium protein. Vaccine antigens can also include cancer antigens or fragments thereof. In one particular embodiment, for example, the vaccine antigen may be a coronavirus vaccine antigen that is used for prophylaxis against a coronavirus, such as SARS-CoV-1, SARS-CoV-2, MERS-CoV…”)).
Regarding claim 8, modified Kim further discloses which contains an additional layer on the skin-contacting surface of the patch that facilitates the entry of the recombinant SARS-CoV-2 antigenic protein(s) to the epidermis (Kim (Par. 58, “In certain embodiments, the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch). The path may also contain other elements to help maintain the desired flow of the drug compound. For example, the drug reservoir may be in fluid communication with a rate control membrane that helps control the flow rate of the drug compound by modulating its pressure downstream from the reservoir.”) (Par. 54-55 (microneedles and skin)) (Par. 63, “…In one particular embodiment, for example, the vaccine antigen may be a coronavirus vaccine antigen that is used for prophylaxis against a coronavirus, such as SARS-CoV-1, SARS-CoV-2, MERS-CoV, etc. Such vaccine antigens may be derived from a coronavirus or other type of virus…”)), wherein the skin-contacting additional layer contains a permeation enhancer device that enhances the entry of the antigenic protein(s) to the epidermis (Kim (Par. 58, “In certain embodiments, the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch). The path may also contain other elements to help maintain the desired flow of the drug compound. For example, the drug reservoir may be in fluid communication with a rate control membrane that helps control the flow rate of the drug compound by modulating its pressure downstream from the reservoir.”) (Par. 54-55 (microneedles and skin)) (Par. 63, “…In one particular embodiment, for example, the vaccine antigen may be a coronavirus vaccine antigen that is used for prophylaxis against a coronavirus, such as SARS-CoV-1, SARS-CoV-2, MERS-CoV, etc. Such vaccine antigens may be derived from a coronavirus or other type of virus…”)).
Regarding claim 11, modified Kim further discloses in which the permeation enhancer device contains microneedles penetrating the epidermis (Kim (Par. 58, “In certain embodiments, the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch). The path may also contain other elements to help maintain the desired flow of the drug compound. For example, the drug reservoir may be in fluid communication with a rate control membrane that helps control the flow rate of the drug compound by modulating its pressure downstream from the reservoir.”) (Par. 54-55 (microneedles and skin)) (Par. 63, “…In one particular embodiment, for example, the vaccine antigen may be a coronavirus vaccine antigen that is used for prophylaxis against a coronavirus, such as SARS-CoV-1, SARS-CoV-2, MERS-CoV, etc. Such vaccine antigens may be derived from a coronavirus or other type of virus…”)).
Claim(s) 4-6 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Lederman as applied to claims 3 and 1 above, and further in view of Krammer (US Pub. No. 20240210415) hereinafter Krammer.
Kim and Lederman teach the device of claim 3 above.
Regarding claim 4, modified Kim fails to explicitly disclose the limitations of the claim.
However, Krammer teaches wherein the isolated and purified Spike protein or the antigenic fragment thereof lacks the natural cleavage site (Par. 397, “This protocol can be used for both expression vectors, the one expressing secreted RBD as well as the one expressing a soluble, trimeric version of the SARS-CoV-2 spike protein. Expression levels of the RBD are very high in our hands (>20 mg/L culture) while expression levels for the full-length spike are lower (approximately 1 mg/L). Therefore, we use the recombinant RBD (FIG. 4B) for initial screening ELISAs and the full-length spike (FIG. 4A) for confirmatory ELISAs (as described in Part II, Basic Protocol 2). Preparation of plasmids for mammalian cell expression are not described here. The expression vector constructs were described previously (Amanat, 2020). In brief, the sequences used for both proteins are based on the genomic sequence of the first isolate, Wuhan-Hu-1, which was released on January 10th 2020 (GenBank: MN908947.3). Sequences were codon optimized for mammalian cell expression. The full-length spike protein sequence was modified to remove the polybasic cleavage site, which is recognized by furin and to add a pair of stabilizing mutations (FIG. 4A). These two modifications were included to enhance the stability of the protein based on published literature”).
Kim, Lederman, and Krammer are considered to be analogous art to the claimed invention as they are involved with biological detection.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kim and Lederman with that of Krammer to include wherein the isolated and purified Spike protein or the antigenic fragment thereof lacks the natural cleavage site through the substitution of proteins as it would have yielded the predictable result of improving protein stability (Krammer (Par. 397)).
Regarding claim 5, modified Kim fails to explicitly disclose the limitations of the claim.
However, Krammer teaches wherein the isolated and purified Spike protein or one or more fragments thereof are produced in either of the following eukaryotic cells: mammalian cells, insect cells (Par. 397, “This protocol can be used for both expression vectors, the one expressing secreted RBD as well…” “…Sequences were codon optimized for mammalian cell expression. The full-length spike protein sequence was modified to remove the polybasic cleavage site, which is recognized by furin and to add a pair of stabilizing mutations (FIG. 4A). These two modifications were included to enhance the stability of the protein based on published literature”) (Par. 571, “We generated two different versions of the spike protein. The first construct expresses a full length trimeric and stabilized version of the spike protein and the second only the much smaller receptor binding domain (RBD)…” “…The same vectors as for the full length S protein were used to express the RBD. In mammalian cells, the RBD domain gave outstanding yields”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kim and Lederman with that of Krammer to include wherein the isolated and purified Spike protein or one or more fragments thereof are produced in either of the following eukaryotic cells: mammalian cells, insect cells for the reasoning as indicated in claim 4 above.
Regarding claim 6, modified Kim fails to explicitly disclose the limitations of the claim.
However, Krammer teaches wherein the recombinant SARS-CoV-2 virus protein antigen fragment is the receptor binding domain (RBD-protein) of the Spike protein (Par. 397, “This protocol can be used for both expression vectors, the one expressing secreted RBD as well…” “…Sequences were codon optimized for mammalian cell expression. The full-length spike protein sequence was modified to remove the polybasic cleavage site, which is recognized by furin and to add a pair of stabilizing mutations (FIG. 4A). These two modifications were included to enhance the stability of the protein based on published literature”) (Par. 571, “We generated two different versions of the spike protein. The first construct expresses a full length trimeric and stabilized version of the spike protein and the second only the much smaller receptor binding domain (RBD)…” “…The same vectors as for the full length S protein were used to express the RBD. In mammalian cells, the RBD domain gave outstanding yields”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kim and Lederman with that of Krammer to include wherein the recombinant SARS-CoV-2 virus protein antigen fragment is the receptor binding domain (RBD-protein) of the Spike protein for the reasoning as indicated in claim 4 above.
Kim and Lederman teach the device of claim 1 above.
Regarding claim 9, modified Kim fails to explicitly disclose the limitations of the claim.
Kim does disclose differing matrix materials (Kim (Par. 56, “The reservoir may be an open volume space, gel, solid structure, etc. Nevertheless, in most embodiments, the reservoir is a solid matrix through which the drug compound is capable of flowing…” “… polymeric materials are often used to form the solid matrix, such as silicones, acrylic resins, olefinic polymers (e.g., ethylene vinyl acetate), plasticized polyvinyl acetate/polyvinyl chloride resins, plasticized hydrolyzed polyvinyl alcohol, rubber-based adhesives (e.g., polyisobutylenes extended with a solvent such as mineral oil), plasticized polyvinyl chloride, polyethylene glycols and polypropylene glycols of varying molecular weights, cellulose esters, etc…”)).
However, Krammer teaches wherein the matrix includes or consists of a glass fiber layer, onto which the antigen-storing compartment which includes one or more recombinant SARS-CoV-2 antigenic protein(s) dried on (Par. 148, “a recombinant soluble SARS-CoV-2 spike protein described herein is immobilized (e.g., coated) on a solid support and the binding of antibody in a sample (e.g., a biological sample) to the recombinant soluble SARS-CoV-2 spike protein is detected. Solid supports include silica gels, resins, derivatized plastic films, glass surfaces, cellulose, polyacrylamide, nylon, polystyrene, polyvinyl chloride, polypropylene, beads (e.g., glass beads, plastic beads, magnetic beads, or polystyrene beads), or alumina gels. In some embodiments, a recombinant soluble SARS-CoV-2 spike protein described herein is immobilized (e.g., coated) on a bead (e.g., a glass bead, plastic bead, magnetic bead, or polystyrene bead), a test strip, a microtiter plate, a membrane, a glass surface, a slide (e.g., a microscopy slide), a microarray, a column (e.g., a chromatography column), or a biochip.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kim and Lederman with that of Krammer to include wherein the matrix includes or consists of a glass fiber layer, onto which the antigen-storing compartment which includes one or more recombinant SARS-CoV-2 antigenic protein(s) dried on through the combination of references as differing support structures are known in the art (Krammer (Par. 148)), and it would have yielded the same or similar result of supporting the protein (Krammer (Par. 148)).
Regarding claim 10, modified Kim fails to explicitly disclose the limitations of the claim.
Kim does disclose in which the matrix contains a hydrogel (Kim (Par. 56, “The reservoir may be an open volume space, gel, solid structure, etc. Nevertheless, in most embodiments, the reservoir is a solid matrix through which the drug compound is capable of flowing…” “… polymeric materials are often used to form the solid matrix, such as silicones, acrylic resins, olefinic polymers (e.g., ethylene vinyl acetate), plasticized polyvinyl acetate/polyvinyl chloride resins, plasticized hydrolyzed polyvinyl alcohol, rubber-based adhesives (e.g., polyisobutylenes extended with a solvent such as mineral oil), plasticized polyvinyl chloride, polyethylene glycols and polypropylene glycols of varying molecular weights, cellulose esters, etc…”)).
However, Krammer teaches further discloses in which the matrix contains a hydrogel, in which the antigen-storing compartment includes one or more recombinant, SARS-Co V-2 antigenic protein(s) embedded in the hydrogel (Par. 148, “a recombinant soluble SARS-CoV-2 spike protein described herein is immobilized (e.g., coated) on a solid support and the binding of antibody in a sample (e.g., a biological sample) to the recombinant soluble SARS-CoV-2 spike protein is detected. Solid supports include silica gels, resins, derivatized plastic films, glass surfaces, cellulose, polyacrylamide, nylon, polystyrene, polyvinyl chloride, polypropylene, beads (e.g., glass beads, plastic beads, magnetic beads, or polystyrene beads), or alumina gels. In some embodiments, a recombinant soluble SARS-CoV-2 spike protein described herein is immobilized (e.g., coated) on a bead (e.g., a glass bead, plastic bead, magnetic bead, or polystyrene bead), a test strip, a microtiter plate, a membrane, a glass surface, a slide (e.g., a microscopy slide), a microarray, a column (e.g., a chromatography column), or a biochip.”) .
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kim and Lederman with that of Krammer to include in which the matrix contains a hydrogel, in which the antigen-storing compartment includes one or more recombinant, SARS-Co V-2 antigenic protein(s) embedded in the hydrogel through the combination of references as differing support structures are known in the art (Krammer (Par. 148)), and it would have yielded the same or similar result of supporting the protein (Krammer (Par. 148)).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Lederman as applied to claim 1 above, and further in view of Sathyanarayanan (US Pub. No. 20250114445) hereinafter Sriram.
Kim and Lederman teach the device of claim 1 above.
Regarding claim 7, modified Kim fails to explicitly disclose the limitations of the claim.
However, Sriram teaches wherein the recombinant SARS-CoV-2 antigenic protein(s) are present in extracellular vesicles (ECVs), by which the protein(s) preserve the structure required for antigenicity (Par. 114, “present disclosure is directed to an engineered EV that delivers one or more antigens, e.g., derived from a coronavirus, e.g., SARS-CoV-1 virus and/or SARS-CoV-2 virus. The EV platform allows luminal expression of one or more antigens and surface expression of one or more antigens designed to create a modular vaccination system. Various adjuvants can be incorporated into the EVs...”).
Kim, Lederman, and Sriram are considered to be analogous art to the claimed invention as they are involved with immune responses.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Kim and Lederman with that of Sriram to include wherein the recombinant SARS-CoV-2 antigenic protein(s) of Kim are present in extracellular vesicles (ECVs), by which the protein(s) preserve the structure required for antigenicity through the combination of references as it would have yielded the predictable result of transporting the antigen to the desired location (Sriram (Par. 114)).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Lederman as applied to claim 1 above, and further in view of Kasempimolporn et al. (“Application of transdermal patches with new skin test reagents for detection of latent tuberculosis”, 2019) hereinafter Kasempimolporn (Examiner's Note: in IDS provided by applicant, filed 04/03/2025).
Kim and Lederman teach the device of claim 1 above.
Regarding claim 21, modified Kim further discloses A diagnostic method for detecting the cellular immune response against SARS-CoV-2 virus in a human patient (Kim (Par. 58, “In certain embodiments, the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch)…”) (Par. 63, “the vaccine antigen may be a coronavirus vaccine antigen that is used for prophylaxis against a coronavirus, such as SARS-CoV-1, SARS-CoV-2, MERS-CoV, etc…”)), comprising:
- a patch according to claim 1 (as taught by Kim and Lederman in claim 1 above) is applied to the skin surface of a human patient (Par. 55, “Regardless of the type employed, the microneedle assembly can deliver a controlled volume of a drug compound through the skin. For example, the microneedle assembly may be placed adjacent to the skin of a subject (e.g., human) and pressure may be applied thereto so that the microneedles penetrate into at least the stratum corneum of the epidermis.”).
Kim fails to explicitly disclose at least 12 or at least 24 hours, after application of the patch, the patch is removed.
Kim does teach a controlled release (Kim (Par. 58, “The particular materials, thickness, etc. of the rate control membrane can vary based on multiple factors, such as the viscosity of the drug compound, the desired delivery time, etc. The rate-controlling membrane may, for instance, include a permeable, semi-permeable or microporous material. Suitable membrane materials include, for instance, fibrous webs (e.g., woven or nonwoven), apertured films, foams, sponges, etc…”)) and time for sufficient contact with the skin (Kim (Par. 65, “Regardless, the microneedles may be placed into contact with the skin of a subject and allowed to remain for a period of time sufficient to contact a bodily fluid (e.g., blood) from the subject that contains an analyte of interest.”)).
However, Kasempimolporn teaches at least 12 or at least 24 hours, after application of the patch, the patch is removed (Page 1316, Col. 2, “The patches were then removed 48 h later, and the results were read after a further 24 h.”) (Page 1317, Col. 1, (patches removed after 48 hour)).
Kim, Lederman, and Kasempimolporn are considered to be analogous art to the claimed invention as they are involved with immune responses.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Kim and Lederman with that of Kasempimolporn to include at least 12 or at least 24 hours, after application of the patch of Kim, the patch of Kim is removed through the combination of references as it would have yielded the predictable result of contacting the bodily fluid for sufficient time (Kim (Parr. 65)) and evaluate delayed type hypersensitivity response in a patient (Lederman (Par. 291-292)) (Kasempimolporn (Page 1317, Col. 1-2 (Par. 1))).
Kim fails to explicitly disclose after removal of the patch, at least 36 or at least 48 hours after application, the extent of the inflammatory skin reaction is observed in the skin area corresponding to the location of the antigen-carrying compartment and the skin area corresponding to the location of the reference compartment, comparing the degree of inflammatory skin reactions in the skin area corresponding to the location of the antigen-carrying compartment and in the skin area corresponding to the reference compartment, wherein the antigen-carrying compartment and the reference compartment are created in separated areas, and if the degree of the inflammatory skin reaction in the skin area corresponding to the location of the antigen-carrying compartment exceeds the degree of inflammatory skin reaction in the skin area corresponding to the reference compartment, the presence of a cellular immune response against SARS-CoV-2 virus in the human patient is determined.
Kim does teach a reference component (Par. 57, “A plurality of reservoirs may also be employed in certain embodiments for storing multiple materials for delivery. The reservoirs may be positioned adjacent to each other, either in a vertical or horizontal relationship. For instance, a first reservoir may contain a drug compound and a second reservoir may contain an excipient (e.g., delivery vehicle, such as alcohols, water, etc.; buffering agents; and so forth)…”), delivery of a plurality of materials from different locations (Par. 57, “A plurality of reservoirs may also be employed in certain embodiments for storing multiple materials for delivery. The reservoirs may be positioned adjacent to each other, either in a vertical or horizontal relationship. For instance, a first reservoir may contain a drug compound and a second reservoir may contain an excipient (e.g., delivery vehicle, such as alcohols, water, etc.; buffering agents; and so forth)…”) (Par. 58, “the microneedle assembly and drug reservoir(s) may be integrated together in the form of a transdermal delivery device (e.g., patch)…”), and drug delivery and analyte detection (Abstract)(Par. 65, “In addition to and/or in lieu of drug delivery, the microneedle assembly may also be employed as a sensor. For example, the microneedle assembly may be used only as a sensor…”) (Par. 66, “Examples of target analytes that the sensor may be used to detect include, but are not limited to, pH or metal ions, proteins, nucleic acids (e.g., DNA, RNA, etc.), drugs, sugars (e.g., glucose), hormones (e.g., estradiol, estrone, progesterone, progestin, testosterone, androstenedione, etc.), carbohydrates, or other analytes of interest…”).
However, Lederman further teaches
- at least 36 or at least 48 hours after application , the extent of the inflammatory skin reaction is observed in the skin area corresponding to the location of the antigen-carrying and the skin area corresponding to the location of the reference (Par. 291, “skin reaction is monitored about 48 to 72 hours post-injection by measuring the longest and midpoint orthogonal diameters of the indurated area in millimeters…”) (Par. 307, “Delayed type hypersensitivity reactions are assessed after 48, 78 and 96 hours after administration”) (Par. 305, “The subjects are injected at pre-determined sites two inches apart from each other on the volar aspect of one forearm with a 0.1 mL 1× dose of each of the peptide pools, followed by the administration of a 0.1 mL 10× dose of each of the peptide pools, vehicle control (negative control), and commercially available Candida albicans antigens (CANDIN®) (positive control) at pre-determined sites on the volar aspect of the other forearm. Each subject will receive a total of 8 intradermal injections at least 2 inches apart.”) (Par. 296, “Example 4. Skin Test Using the Methods of this Disclosure”),
- comparing the degree of inflammatory skin reactions in the skin area corresponding to the location of the antigen-carrying and in the skin area corresponding to the reference, wherein the antigen-carrying and the reference are created in separated areas (Par. 305, “The subjects are injected at pre-determined sites two inches apart from each other on the volar aspect of one forearm with a 0.1 mL 1× dose of each of the peptide pools, followed by the administration of a 0.1 mL 10× dose of each of the peptide pools, vehicle control (negative control), and commercially available Candida albicans antigens (CANDIN®) (positive control) at pre-determined sites on the volar aspect of the other forearm. Each subject will receive a total of 8 intradermal injections at least 2 inches apart.”) (Par. 291, “skin reaction is monitored about 48 to 72 hours post-injection by measuring the longest and midpoint orthogonal diameters of the indurated area in millimeters…”), and
- if the degree of the inflammatory skin reaction in the skin area corresponding to the location of the antigen-carrying exceeds the degree of inflammatory skin reaction in the skin area corresponding to the reference, the presence of a cellular immune response against SARS-CoV-2 virus in the human patient is determined (Par. 291, “skin reaction is monitored about 48 to 72 hours post-injection by measuring the longest and midpoint orthogonal diameters of the indurated area in millimeters…”) (Par. 292, “A positive immune reaction in a subject is indicative of the subject having developed a cell-mediated immune response to SARS-CoV-2 and, therefore, has developed cell-mediated immunity against SARS-CoV-2 or has an active SARS-CoV-2 infection. The skin tests may be also correlated with a serological immune response and any symptoms present in the subject.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Kim, Lederman, and Kasempimolporn with that of Lederman to include after removal of the patch of Kim, at least 36 or at least 48 hours after application, the extent of the inflammatory skin reaction is observed in the skin area corresponding to the location of the antigen-carrying compartment of Kim and the skin area corresponding to the location of the reference compartment, comparing the degree of inflammatory skin reactions in the skin area corresponding to the location of the antigen-carrying compartment of Kim and in the skin area corresponding to the reference compartment, wherein the antigen-carrying compartment of Kim and the reference compartment are created in separated areas, and if the degree of the inflammatory skin reaction in the skin area corresponding to the location of the antigen-carrying compartment of Kim exceeds the degree of inflammatory skin reaction in the skin area corresponding to the reference compartment, the presence of a cellular immune response against SARS-CoV-2 virus in the human patient is determined through the combination of references and adding the control of Lederman into an additional reservoir of Kim as it would have yielded the predictable result of providing a comparison to evaluate delayed type hypersensitivity response in a patient (Lederman (Par. 291-292)).
Conclusion
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/ARI S PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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