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 .
Receipt is acknowledged of IDS filed on 06/26/2026.
Claims 1, 7, 15, 17, 83, 84, and 85 have been amended.
Claims 1, 7, 10, 12-13, 15-18, 20, 26-31, 37, 39, 73, 75 and 83-88 are pending.
Claims 2-6, 8, 9, 11, 14, 19, 21-25, 32-36, 38, 40-72, 74, and 76-82 are cancelled.
Claims 20, 26-31, 37, 39, 73 and 75 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
1
Claims 1, 7, 10, 12, 13, 15-18 and 83-88 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.
In the instant case, the specification never explicitly states fractionating heparin to the ranges claimed in instant claim 1, 20kDa to 40kDa or a fractionated samples that has that range of molecular weights. The specification only states the high molecular weight can have a substantial fraction of the heparin chains have a high molecular weight (Applicant’s specification paragraph 0079), but a “fraction of” is different than “fractionated”.
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.
Claims 1, 7, 10, 12, and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to pharmaceutical composition comprising fractionated heparin and a pharmaceutically acceptable excipient. Based upon an analysis with respect to the claims as a whole, claim 1 is directed to a judicial exception (i.e., law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1, 7, 10, 12, and 13 recite naturally occurring compounds and as such is directed towards a law of nature and a natural phenomenon. The claimed compounds do not have markedly different characteristics from what occurs in nature, and are a “product of nature” exception. Further, the claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exceptions.
The rationale for this determination is explained below:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The subject matter, within the scope of the instant claims is construed as a composition comprising fractionated heparin and a pharmaceutically acceptable excipient.
So the answer to Step 1 is: Yes, the claims are drawn to a composition of matter.
Step 2A: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
The claimed subject matter appears to describe a compound that is a natural product, i.e., heparin. A pharmaceutically acceptable excipient can be water and heparin is a naturally occurring polysaccharide belonging to the family of glycosaminoglycans (GAG) ubiquitously present in mast cells (ODUAH. Heparin: Past, Present, and Future. Pharmaceuticals. 2016. Page 1, paragraph 1) and is considered “products of nature,” which falls within each of the categories: “laws of nature” and “natural phenomena.” Thus, the claims are drawn to judicially recognized exception. See p74623, left column, of the Federal Registry notice: …Courts have held that naturally occurring products and some man-made products that are essentially no different from a naturally occurring product are ‘‘products of nature’’ that fall under the laws of nature or natural phenomena exception. (Section I (3); pp. 74622-4, of the Federal Registry notice discusses Natural Products.).
The next question within step 2A is: does the nature based product show “markedly different characteristics” from any naturally occurring counterpart(s) in their natural state, based on structure, function and/or properties?
Heparin is a naturally occurring compound as evidenced by ODUAH above and water, which is a pharmaceutically acceptable excipient, is a naturally occurring product.
“The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. When there is no naturally occurring counterpart to the nature based product, the comparison should be made to the closest naturally occurring counterpart. In the case of a nature-based combination, the closest counterpart may be the individual nature-based components that form the combination, i.e., the characteristics of the claimed nature-based combination are compared to the characteristics of the components in their natural state”.
Establishment of a marked difference cannot be based on some inherent or innate characteristic of the naturally occurring counterpart. See p. 74623, footnote 28:
“To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (‘‘[The inventor did] not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.’’); In re Marden, 47 F.2d 958 (CCPA 1931) (eligibility of a claim to ductile vanadium held ineligible, because the ‘‘ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics’’). Further, a difference in a characteristic that came about or was produced independently of any effort or influence by applicant cannot show a marked difference. Roslin, 750 F.3d at 1338 (Because ‘‘any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee’ ’’ and were ‘‘uninfluenced by Roslin’s efforts’’, they ‘‘do not confer eligibility on their claimed subject matter’’ (quoting Funk Bros.)).
In the instant case, Applicant claims heparin and a pharmaceutically acceptable excipient, which can be water. Heparin and water are naturally occurring. There seems to be no indication in the specification that heparin has any characteristics (structural, functional or other properties) that are different from the naturally occurring counterpart in its natural state. Additionally as taught by HUNG (Basic Amino Acid Residues of Human Eosinophil Derived Neurotoxin Essential for Glycosaminoglycan Binding. International Journal of Molecular Sciences. 2013), high molecular weight heparin has a high level of inhibition 87% of cellular binding of eosinophil derived neurotoxin (EDN) when compared to low molecular weight heparin (Page 19072 paragraph 1). In other words, there seems to be no indication in the specification or otherwise that heparin do not naturally possess the ability to bind to eosinophil granule proteins, as recited by instant claim 10. Thus, the compounds do not have markedly different characteristics from what occurs in nature, and is a “product of nature exception”.
So the answer to Step 2A is: Yes, the claims are drawn to a natural composition.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exemption?
Claim 1 has no additional elements. As set forth above, there seems to be no indication in the specification or otherwise that heparin and a pharmaceutically acceptable excipient, such as water, do not naturally possess binding ability for eosinophil granule proteins. Because the claim does not include any additional features that could add “significant more” to the exception the answer to Step B is: No, the claims do not recite additional elements that amount significantly more than the judicial exception. In sum, applicant’s claims are not directed to a composition that is markedly different in structure from a naturally-occurring product. Therefore, the claims are not directed to patent-eligible subject matter.
The claims do not qualify as eligible subject matter, and are properly rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 7, 10, 12, 13, 17, 18, and 83-88 are rejected under 35 U.S.C. 103 as being unpatentable over PEASE (WO 2011/126984 A1) in view of HUNG (Basic Amino Acid Residues of Human Eosinophil Derived Neurotoxin Essential for Glycosaminoglycan Binding. International Journal of Molecular Sciences. 2013), CONNERS (The New Heparins. Under the Microscope. 2002.) and GRIFFITH (FRACTIONATION OF HEPARIN BY AFFINITY CHROMATOGRAPHY ON COVALENTLY-BOUND HUMAN a-THROMBIN. BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS. 1978.).
Regarding claim 1, PEASE teaches a pharmaceutical composition for diagnosing and monitoring eosinophilic esophagitis in a subject by administering the composition to a subject orally (Page 1, field of invention). The composition uses an antibody to binds to the eosinophil protein (PEASE claims 1 and 4) such as eosinophil derived neurotoxin (EDN) (claim 4). The composition can be made into a solution, which reads on pharmaceutically acceptable excipient (page 47, paragraph 3)
Regarding claims 10 and 12, PEASE teaches the composition binds to EDN (claim 4).
Regarding claim 13, PEASE teaches the composition is administered orally (page 1, field of invention).
Regarding claims 17 and 18, PEASE further teaches the composition is radiolabeled with Tc-99m (PEASE claims 6-7).
Regarding claim 83, PEASE teaches a pharmaceutical composition for diagnosing and monitoring eosinophilic esophagitis in a subject by administering the composition to a subject orally (Page 1, field of invention). The composition uses an antibody to binds to the eosinophil protein (PEASE claims 1 and 4) such as eosinophil derived neurotoxin (EDN) (claim 4). The composition can be made into a solution, which reads on pharmaceutically acceptable excipient (page 47, paragraph 3) PEASE further teaches the composition is radiolabeled with Tc-99m (PEASE claims 6-7).
Regarding claim 86, PEASE teaches the composition binds to EDN (claim 4).
Regarding claim 87, PEASE teaches the composition is administered orally (page 1, field of invention).
Regrading claim 88, PEASE further teaches the composition is radiolabeled with Tc-99m (PEASE claims 6-7).
PEASE does not teach using high molecular weight heparin in the composition or that the heparin is fractionated.
HUNG teaches high molecular weight heparin has a high level of inhibition 87% of cellular binding of eosinophil derived neurotoxin (EDN) when compared to low molecular weight heparin (Page 19072 paragraph 1). Various glycosaminoglycans (GAGs), including high molecular weight heparin, were tested for binding. Natural heparin is a heterogenous mixture of molecular weights ranging from 5,000 Da to over 40,000 (Page 19076, paragraph 1). The molecular weight of heparin chains is correlated to the molecular weight of the heparin itself.
Regarding claim 85, HUNG teaches high molecular weight heparin has a high level of inhibition 87% of cellular binding of eosinophil derived neurotoxin (EDN) when compared to low molecular weight heparin (Page 19072 paragraph 1). Furthermore, the prior art’s composition would have the same chemical/physical properties of “wherein a binding affinity of the heparin for one or more eosinophil granule proteins is greater than a binding affinity of a low molecular weight heparin for the one or more eosinophil granule proteins” as claimed by Applicant, because the prior art has the same ingredients as claimed by Applicant, unless proven otherwise.
CONNERS teaches that a nonuniform size of heparin distribution can lead to unpredictable dose response, due to the different sizes of heparin in the heterogenous mixture have different effects (page 42, paragraphs 2-3). This means a more unform size of heparin will allow it to be more specific in its effect on the patient being administered it.
GRIFFITH teaches that to get a uniform size, fractionating via affinity chromatography can be used (abstract). Gel filtration can be used to fractionate the heparin into molecular size classes (abstract).
Note, Applicant recites that high molecular weight heparin, heparin with a molecular weight of 20 kDa or greater (such as the heparin recited in instant claim 1), is heparin with a high purity, i.e., a substantial fraction of the heparin chains have a high molecular weight (Applicant’s specification, paragraph 0079 and 00159). It appears Applicant is using “fractionated” to mean heparin that has been filtered or separated to have a uniform weight.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate high molecular weight heparin. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the EDN binding antibodies used in PEASE and high molecular weight heparin are functional equivalents of binding agents for EDN commonly used in the pharmaceutical industry. Furthermore, HUNG teaches that high molecular weight heparin has a high level of cellular binding of EDN.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate fractionating the heparin. The person of ordinary skill in the art would have been motivated to make those modifications because it makes the heparin a uniform size which prevents an unpredictable dose effect on the patient and reasonably would have expected success because the references are in the same field of endeavor, such as heparin for administration to a patient.
Regarding claims 1 and 83, the reference does not specifically teach the heparin molecular weight range or heparin chain molecular weight as claimed by the Applicant. The heparin molecular weight and heparin chain molecular weight is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal heparin molecular weight and heparin chain molecular weight in order to best achieve desired results, such as increased binding to the eosinophil derived neurotoxins. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of heparin molecular weight would have been obvious at the time of Applicant’s invention. Furthermore, MPEP 2114.05 states, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”.
Regarding claims 7 and 84, the reference does not specifically teach the effective amount of heparin as claimed by the Applicant. The effective amount of heparin is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the effective amount of heparin in order to best achieve desired results, such having enough heparin for proper binding to the EDN. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the effective amount of heparin would have been obvious at the time of Applicant’s invention.
Claims 1, 7, 10, 12, 13, 15-18 and 83-88 are rejected under 35 U.S.C. 103 as being unpatentable over PEASE (WO 2011/126984 A1) and HUNG (Basic Amino Acid Residues of Human Eosinophil Derived Neurotoxin Essential for Glycosaminoglycan Binding. International Journal of Molecular Sciences. 2013) in view of GREENHAWT (The Management of Eosinophilic Esophagitis. Clinical Management Review. 2013.).
PEASE and HUNG teach Applicant’s invention as discussed above.
PEASE and HUNG do not teach adding a glucocorticoid.
Regarding claims 15 and 16, GREENHAWT teaches that oral administration of glucocorticoids are effective in the treatment of eosinophilic esophagitis (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a glucocorticoid to the composition. The person of ordinary skill in the art would have been motivated to make those modifications, because oral administration of glucocorticoids are effective in the treatment of eosinophilic esophagitis, and reasonably would have expected success because the references are in the same field of endeavor, such as oral treatments eosinophilic esophagitis.
Response to Arguments
Applicant argues the references do not teach using fractionated heparin.
The examiner does not find the argument persuasive because as discussed above, CONNERS teaches the importance of having a uniform size of heparin for administration to a patient, a nonuniform size of heparin distribution can lead to unpredictable dose response, due to the different sizes of heparin in the heterogenous mixture have different effects. This means a more unform size of heparin will allow it to be more specific in its effect on the patient being administered it. GRIFFITH teaches that to get a uniform size, fractionating via affinity chromatography can be used and that gel filtration can be used to fractionate the heparin into molecular size classes. Note, Applicant recites that high molecular weight heparin, heparin with a molecular weight of 20 kDa or greater (such as the heparin recited in instant claim 1), is heparin with a high purity, i.e., a substantial fraction of the heparin chains have a high molecular weight (Applicant’s specification, paragraph 0079 and 00159). It appears Applicant is using “fractionated” to mean heparin that has been filtered or separated to have a uniform weight.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate fractionating the heparin. The person of ordinary skill in the art would have been motivated to make those modifications because it makes the heparin a uniform size which prevents an unpredictable dose effect on the patient and reasonably would have expected success because the references are in the same field of endeavor, such as heparin for administration to a patient.
Applicant argues that an articulated rational has not been provided for optimization.
The examiner does not find the argument persuasive because as discussed above, the molecular weight can be increased to a specific size to increase binding to the eosinophil derived neurotoxins.
Applicant argues, Hung does not recognize fractionation or the specific molecular weight
parameters as result-effective variables. Hung's unfractionated heparin is described as already exhibiting the desired 87% inhibition of cellular binding of EDN, so a person of ordinary skill in the art
would have no motivation to fractionate it.
The examiner does not find the argument persuasive because as discussed above, CONNER teaches that a nonuniform size of heparin distribution can lead to unpredictable dose response, due to the different sizes of heparin in the heterogenous mixture have different effects (page 42, paragraphs 2-3). This means a more unform size of heparin will allow it to be more specific in its effect on the patient being administered it. GRIFFITH teaches that fractionating the heparin is a way of achieving this uniform size of heparin.
Therefor it would be obvious to incorporate fractionating the heparin to maintain the high binding desired and prevent any unwanted side effects in the patient.
Applicant argues, the prior art teaches away from high molecular weight heparin.
The examiner does not find the argument persuasive because as discussed above, PEASE is towards a composition that binds to the eosinophil protein and HUNG teaches that high molecular weight achieves a high binding to the eosinophil protein. Although some of the references discuss that low molecular weight heparin is preferred for other compositions, only high molecular weight heparin achieves the desired function needed for PEASE.
Applicant argues, that there is no reasonable expectation of success. The as-filed specification explains that "the lack of uniformity in chain length [in native heparin] creates major difficulties in isolating a particular molecular weight of heparin" and that "there has not been similar progress in developing methods of purifying high molecular weight heparin" (paragraph [0077]). This demonstrates that a person of ordinary skill would not have had a reasonable expectation of success in obtaining the claimed fractionated heparin composition.
The examiner does not find the argument persuasive because as discussed above, GRIFFITH teaches a method of isolating specific molecular weights using gel filtration. It is unclear why this method could not be used for the specific molecular weights claimed in instant claim 1. Furthermore, even if a method is specifically towards isolating the low molecular weight heparin, the high molecular weight heparin would inherently also be isolated out since the low molecular weight heparin in the composition would be isolated from (taken out of) the mixture, this would only leave the high molecular weight heparin. Even if methods discard the high molecular weight heparin, the method still achieved an isolation of high molecular weight heparin.
Applicant argues that the claimed range is critical as described in the declaration. The Declaration under 37 C.F.R. § 1.132 by Dr. Gerald J. Gleich, filed November 17, 2025, demonstrates that the claimed fractionated high molecular weight heparin exhibits a 2.4-fold improvement in molar potency compared to unfractionated heparin. This is a difference in kind, not merely degree, as it represents a fundamentally different mechanism of action through multiple binding sites or stronger electrostatic interactions. The Declaration further demonstrates a 7.7-fold improvement in molar potency of high molecular weight heparin over low molecular weight heparin. Specifically, as shown in Table 1 of the Declaration, high molecular weight heparin having an average molecular weight of 23 kDa exhibited an IC50 of 2.26E-07 M, compared to 5.48E-07 M for unfractionated heparin and l.75E-06 M for low molecular weight heparin. These results demonstrate that the claimed molecular weight range represents a critical range where superior efficacy is achieved, which was not disclosed or suggested by the prior art.
The examiner does not find the argument persuasive because, in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980).
In the instant case, as discussed above, HUNG teaches high molecular weight heparin has a high level of inhibition 87% of cellular binding of eosinophil derived neurotoxin (EDN) when compared to low molecular weight heparin (Page 19072 paragraph 1). HUNG teaches the unexpected results claimed by Applicant. Furthermore, Table 1, of the declaration, does indeed show high molecular weight heparin and unfractionated heparin, the molecular weights of the two are different (high molecular weight heparin is 23 kDa, while unfractionated heparin is 15 kDa). Therefor it is unclear if these “unexpected properties” as claimed are indeed due to the fractionation of heparin or simply due to the molecular weight of the two heparins tested and the high molecular weight heparin having a higher molecular weight, since as discussed in the rejection via HUNG, high molecular weight heparin binds better to the eosinophil derived neurotoxin.
Additionally, even if the results are seen as unexpected, since the composition is comprised of a naturally occurring product, that is also taught in the prior art, it appears that the results are a newly discovered property of a product and not unexpected results. MPEP 2112 states, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618
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