DETAILED ACTION
Claims 1-8, 10-11, and 26 are pending. Of these, claim 11 is withdrawn as directed to a nonelected invention. Therefore, claims 1-8, 10, and 26 are under consideration on the merits.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/5/2026 has been entered.
Status of the Rejections
The 101 rejection is maintained.
The 112(b) rejection is withdrawn in part and maintained in part in view of the amendment, and a new rejection was necessitated by the amendment.
The 103 rejection is revised in view of the amendment.
The provisional double patenting rejection is revised in view of the amendment.
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 1-8, 10, and 26 are rejected under 35 U.S.C. 101 as lacking utility (Nature Based Product-Judicial Exception).
Claims 1-8, 10, and 26 are drawn to compositions of matter, which are one of the four categories of statutory subject matter. Therefore, whether the claims lack utility is determined by whether the claims are directed to a judicial exception, and, if so, whether the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, using the Step 2A Prong One, Step 2A Prong Two, and Step 2B analysis. See MPEP 2106.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Claim 1 is directed to a sterile and desiccated biomaterial comprising devitalized differentiated cells having tissue regenerating and/or repairing properties, and a particulate material wherein gelatin is the elected species, wherein the cells and the particulate material are embedded in an extracellular matrix. The skilled artisan would recognize that cells are products of nature, and claim 1 makes it clear that the particulate material also may be a product of nature by reciting that the particulate material may be an organic material such as demineralized bone matrix, gelatin, chitosan, chondroitin sulfate, collagen, elastin, fibrinogen, fibrin, fibronectin, proteoglycans, heparan sulfate proteoglycans, hyaluronic acid, polysaccharides, or laminins. Therefore, the present claims encompass compositions that contain only a mixture of naturally occurring components.
Since the claims read on mixtures of naturally-occurring components, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is an organ or skin from a deceased animal located in an arid desert environment. The skin or other organ would comprise an extracellular matrix comprising collagen. Differentiated cells having regenerating and/or repairing properties would be embedded within the collagen, and any organic material in the matrix would be a “particulate material” as recited by claim 1. For example, claim 1 recites that the particulate material may be an organic material such as elastin, and the skilled artisan would recognize that elastin would be present in the dermis layer of the skin.
While claim 1 further recites additional elements relating to the properties of the biomaterial, i.e., that the biomaterial is sterile and dessicated, and that the differentiated cells are devitalized and have tissue regenerating and/or repairing properties, tissue regenerating and/or repairing abilities are inherent properties of the cells present in body organs, and the cells in an organ or skin from a deceased animal located in an arid environment would become devitalized, sterile, and desiccated over time due to the environmental conditions. Therefore, claim 1 fails to recite any additional elements that would change the structure, function or other characteristics of the individual natural components in any way.
Consequently, claim 1 recites a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
Here, the language of claim 1, in addition to the recitation of structural elements of the biomaterial, recites the steps by which the biomaterial is generated, i.e., by contacting viable cells capable to under differentiation with a particulate material followed by culturing in a culture medium such that the cells secrete an extracellular matrix and synthesize a factors content to acquire tissue regenerating and/or repairing properties, and wherein the cells and the particulate material are embedded in the extracellular matrix so as to form a multidimensional structure. These limitations, however, merely specify the manner by which the biomaterial is made and therefore fails to recite any additional elements relating to a practical application of the exception. Therefore, claim 1 is directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05.
Here, the language of claim 1, in addition to the recitation of structural elements of the biomaterial, recites the steps by which the biomaterial is generated, i.e., by contacting viable cells capable to under differentiation with a particulate material followed by culturing in a culture medium such that the cells secrete an extracellular matrix and synthesize a factors content to acquire tissue regenerating and/or repairing properties, and wherein the cells and the particulate material are embedded in the extracellular matrix so as to form a multidimensional structure. These limitations, however, merely specify the manner by which the biomaterial is made and therefore fails to recite any additional element of the composition which would amount to ‘significantly more’ than the judicial exception itself and thus the claim as a whole does not amount to significantly more than the judicial exception.
Conclusion: Claim 1 which encompasses a composition that may comprise only a mixture of natural products, is not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Subsequently, claim 1 is directed toward a judicial exception under 35 USC 101. Additionally, dependent claims 2-8, 10, and 26 do not recite any further element which would be considered to provide ‘significantly more’ than the judicial exception.’ Consequently, claims 1-8 and 10 prima facie lack utility under 35 USC 101.
Response to Applicant’s Arguments
Applicant argues that base claim 1 has been amended to recite the steps used to obtain the biomaterial, such that the claim is not directed to a product of nature and/or the claim recites additional elements to qualify for the Step 2A Prong Two practical application.
In response, this is not persuasive because the amendment to claim 1 to incorporate product by process steps does not result in a composition having markedly different characteristics from its naturally occurring counterpart based upon the evidence of record as discussed above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 4 recites “a polymer, including” followed by a list of species. The recitation of “including” renders the metes and bounds of the claim unclear, because it is unknown if “including” is intended to signal that the list of species following “including” is exhaustive such that the species of polymer must be selected from one of the species that is explicitly recited. Clarification is required. For the purpose of examination, claim 4 has been given its broadest reasonable interpretation, which is that the polymer is not limited to the recited list of exemplary species.
Response to Applicant’s Arguments
Applicant argues that the claims have been amended to delete the indefinite language, but claim 4 continues to recite “a polymer, including” which is indefinite as discussed above. Therefore, the rejection as to claim 4 is maintained.
Claims 1-8, 10, and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 “an organic material, including” followed by a list of species, and “aceramic material, including” followed by a list of species. The use of “including” renders the metes and bounds of the claim unclear, because it is unknown if “including” is intended to signal that the list of species following “including” is exhaustive such that the species must be selected from one of the species that is explicitly recited. Clarification is required. For the purpose of examination, claim 1 has been given its broadest reasonable interpretation, which is that the species is not limited to the recited list of exemplary species. Since dependent claims 2-8, 10, and 26 do not clarify the point of confusion, they are also rejected.
Additionally, since lines 4-5 of claim 1 recites the Markush language “selected from the group consisting of,” all species in the group should be separated by “and.” The list of ceramic material species, however, includes the use of “or” to separate species in front of “calcium hydroxide” and “combinations thereof.” Clarification is required. Since dependent claims 2-8, 10, and 26 do not clarify the point of confusion, they are also indefinite.
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.
Claims 1-8, 10, and 26 are rejected under 35 U.S.C. 103 as unpatentable over Egusa (US Pat. Pub. 2016/0287753 (published 10.6.2016); of record in IDS) in view of Kiminami et al. (published 6.23.2016)(US Pat. Pub. 2016/0175481).
As to claims 1-8,10, and 26, Egusa discloses a bone regeneration biomaterial comprising inactivated (“devitalized”) stem cells (i.e., the elected species of “cells” of claims 1-2) and mineral particles such as calcium phosphate particles (a “particulate material” of claims 1 and 4) embedded in an extracellular matrix (paragraphs 23 and 84). The stem cells may be sterilized (paragraph 105). The stem cells are inactivated via lyophilization (“freeze-drying” of claim 10 which will result in dessication of the biomaterial as recited by claim 1 (paragraph 23, step 12 and paragraph 105).
As to claims 1-8,10, and 26, Equsa does not further expressly disclose that the particulate material comprises the elected species of particulate of claims 1 and 4, i.e., gelatin, or that the biomaterial is obtained by contacting viable cells capable to under differentiation with a particulate material followed by culturing in a culture medium such that the cells secrete an extracellular matrix and synthesize a factors content to acquire tissue regenerating and/or repairing properties, and wherein the cells and the particulate material are embedded in the extracellular matrix so as to form a multidimensional structure as recited by claim 1. Nor does Equsa expressly teach that the number of viable cells is within the range of claims 3 and 26, or that the biomaterial comprises an altered factors content as recited by claim 5 such as altered growth factors and/or transcription factors (claim 6) such as one of the factors recited by claim 7 or RNA content as recited by claim 8. Nor does Equsa disclose that the particulate material further comprises one of the ingredients recited by claim 4, such as polylactic acid or PLGA.
Kiminami discloses a bone regeneration kit comprising a bioabsorbable polymer such as at least one of gelatin, polylactic acid, or PLGA, and a bone regeneration material such as a calcium phosphate having adsorbed inositol phosphate (paragraphs 1, 19, 22, 40). Kiminami teaches that the use of a combination of a particle comprising the bioabsorbable polymer and a particle comprising a calcium salt with adsorbed inositol phosphate provides a material that provides anti-washout properties after filling even when in contact with water such as blood or other biological fluids (paragraph 18).
As to claims 1-8,10, and 26, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Egusa biomaterial by incorporating a gelatin particulate along with a polylactic or PLGA particulate into the biomaterial as an additional particulate to the mineral particulate taught by Egusa, along with calcium phosphate particles with adsorbed inositol phosphate, because Kiminami teaches that combining a gelatin, polylactic acid, and/or PLGA particle with a calcium mineral particle with inositol phosphate adsorbed on its surface in a bone regeneration material results in an improved material that provides anti-washout properties after filling, such that the skilled artisan reasonably would have expected that incorporating such particles into the Kiminami bone regeneration material would advantageously impart anti-washout properties to the material. The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
The modified prior art composition as discussed above will comprise the viable cell count of claims 3 and 26 and an altered factors content as recited by claim 5 such as altered growth factors and/or transcription factors (claim 6) such as one of the factors recited by claim 7 or RNA content as recited by claim 8, because it comprises the same ingredients recited by the claims and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Regarding the limitation of claim 1 that the biomaterial is obtained by contacting viable cells capable to under differentiation with a particulate material followed by culturing in a culture medium such that the cells secrete an extracellular matrix and synthesize a factors content to acquire tissue regenerating and/or repairing properties, and wherein the cells and the particulate material are embedded in the extracellular matrix so as to form a multidimensional structure, this limitation renders claim 1 into a product by process claim, such that its patentability is determined by the structure of the composition and not the steps by which it is made. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
Here, the product by process steps recited by claim 1 result in a sterile, dessicated multidimensional structure comprising an extracellular matrix in which the cells and the particulate material are embedded, which is the same structure of the biomaterial taught by Egusa as discussed above. Therefore, the structure of the claimed biomaterial claim is the same as or obvious from a product of the prior art based upon the evidence of record.
Response to Applicant’s Arguments
Applicant argues that Egusa discloses cell aggregates wherein the mineral is deposited in situ by the cells themselves during differentiation, and does not disclose adding a separate, preformed particulate material by contacting viable cells with the material as recited by claim 1 as amended. Applicant argues that Kiminami hypothesizes that the reason for the anti-washout property discussed therein is thought to be due to interaction between the gelatin particle and an inositol phosphate adsorbed on the surface of a particle comprising a calcium salt. Applicant further argues that Egusa’s mineral deposits do not contain inositol phosphate, and concludes that the cited art therefore does not support that combining the teachings of the references as laid out in the rejection would predictably yield anti-washout properties.
In response, and as discussed in the revised grounds of rejection, it would have been prima facie obvious to incorporate calcium phosphate particles having adsorbed inositol phosphate into the Equsa biomaterial in order to obtain the anti-washout properties.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8, 10, and 26 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of U.S. Pat. Appl. No. 17/273,143 and in view of Egusa (US Pat. Pub. 2016/0287753) and/or Kiminami et al. (US Pat. Pub. 2016/0175481) where indicated below.
The teachings of Egusa and Kiminami are relied upon as discussed above.
The reference claims recite a biomaterial comprising stem cells and gelatin particles in an extracellular matrix.
Although the reference claims do not recite that the biomaterial is sterile and desiccated such that it comprises devitalized cells, it would have been prima facie obvious to use sterile and desiccated cells in light of Egusa’s suggestion that a biomaterial comprising stem cells and gelatin particulate material embedded in an extracellular matrix can be lyophilized and sterilized. The resulting composition will possess a number of viable cells is within the ranges of claims 3 and 26, and the biomaterial will comprise an altered factors content as recited by claim 5 such as altered growth factors and/or transcription factors (claim 6) such as one of the factors recited by claim 7 or RNA content as recited by claim 8, because it comprises the same ingredients recited by the claims and a product cannot be separated from its properties.
Although the reference claims do not recite the incorporation of a polylactic or PLGA particulate material as recited by claim 4, it would have been prima facie obvious to do so because Kiminami teaches that combining a gelatin, polylactic acid, and/or PLGA particle with a calcium mineral particle with inositol phosphate adsorbed on its surface in a bone regeneration material results in an improved material that provides anti-washout properties after filling.
Although the reference claims do not recite that the biomaterial is obtained by contacting viable cells capable to under differentiation with a particulate material followed by culturing in a culture medium such that the cells secrete an extracellular matrix and synthesize a factors content to acquire tissue regenerating and/or repairing properties, and wherein the cells and the particulate material are embedded in the extracellular matrix so as to form a multidimensional structure as recited by claim 1, this language renders claim 1 into a product by process claim, such that its patentability is determined by the structure of the composition and not the steps by which it is made. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
Here, the product by process steps recited by claim 1 result in a sterile, dessicated multidimensional structure comprising an extracellular matrix in which the cells and the particulate material are embedded, which is the same structure of the biomaterial taught by the reference claims as discussed above. Therefore, the structure of the claimed biomaterial claim is the same as or obvious from the reference composition based upon the evidence of record.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Response to Applicant’s Arguments
Applicant argues that a terminal disclaimer has been filed.
In response, the terminal disclaimer was disapproved. Therefore, the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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